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IND Approval Marks Key Step in Beginning of Potentially Pivotal Trial of Berubicin
HOUSTON (December 17, 2020) – CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) (“CNS” or the “Company”), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announced that the Investigational New Drug (IND) application for its lead product candidate, Berubicin, for the treatment of Glioblastoma Multiforme (GBM) is now approved and in effect as filed with the US Food and Drug Administration (FDA). The Company will initiate its trial during the first quarter of 2021 to investigate the efficacy of Berubicin in adults with GBM who have failed first-line therapy. Recent correspondence between the Company and the FDA resulted in modifications to the previously disclosed trial design, including designating overall survival (OS) as the primary endpoint of the study. OS is a rigorous endpoint that the FDA has recognized as a basis for approval of oncology drugs when a statistically significant improvement can be shown relative to a randomized control arm.
“Since becoming a public company, our clear focus has been on advancing the clinical development of Berubicin. We will now rapidly move to initiate our Phase 2 trial of Berubicin for adults with GBM and expect to begin enrolling patients in the first quarter of next year,” commented John Climaco, CEO of CNS Pharmaceuticals. “The Company will transform within the next several months as Berubicin becomes the subject of up to three active clinical trials, which include our randomized, controlled Phase 2 trial in the U.S., and 2 trials planned by our sublicensee WPD in Poland. We are entering an area with significant unmet medical need since the current treatment paradigm for GBM remains bleak, as this aggressive and currently incurable form of brain cancer continues to claim high mortality rates. We have a tremendous opportunity ahead of us as we continue our mission to improve patient outcomes for GBM and build on the promising results demonstrated by Berubicin in its Phase 1 clinical trial.”
As previously announced, the planned trial will evaluate the efficacy of Berubicin in patients with GBM who have failed primary treatment for their disease. Results will compare Berubicin to the current standard of care, with a 2 to 1 randomization of patients to either receive Berubicin or Lomustine. The trial’s adaptive design is intended to allow an interim analysis of the data to demonstrate meaningful differences in efficacy between treatments and then to allow an adjustment to the size of the patient population in the trial for maximum efficiency in terms of time in development. Based on this, the trial has the potential to provide data to the FDA that may allow an expedited pathway for development. However, there can be no assurance that the FDA will support any potential request for an expedited pathway to approval or further development.
About CNS Pharmaceuticals, Inc.
CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. related to a completed Phase 1 clinical trial with Berubicin in malignant brain tumors, which Reata conducted in 2006. In this trial the overall response rate of stable disease or better was 44%. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of Feb. 20, 2020. These Phase 1 results represent a limited patient sample size and, while promising, are not a guarantee that similar results will be achieved in subsequent trials. By the end of the first quarter of 2021, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland. Its second drug candidate, WP1244, is a novel DNA binding agent that has shown in preclinical studies that it is 500 times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.
For more information, please visit www.CNSPharma.com.
Forward-Looking Statements
Some of the statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company and WPD to initiate clinical trials during the first quarter of 2021, and whether the planned clinical trial will provide data to the FDA to allow an expedited pathway for development. These statements relate to future events, future expectations, plans and prospects. Although CNS believes the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including those discussed under Item 1A. “Risk Factors” in CNS’s most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in its Form 10-Q filings and in its other public filings with the SEC. Any forward-looking statements contained in this press release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
CONTACTS:
Investor Relations Contact
James Salierno
The Ruth Group
646-536-7028
Media Contact
Annika Parrish
The Ruth Group
(720) 412-9042
Corporate Communications
InvestorBrandNetwork (IBN)
Los Angeles, California
www.InvestorBrandNetwork.com
310.299.1717 Office
Editor@InvestorBrandNetwork.com
SOURCE: CNS Pharmaceuticals, Inc
Expects to initiate Phase 2 trial during the first quarter of 2021
Houston, TX – November 17, 2020 – CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) (“CNS” or the “Company”), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announced that it has submitted an Investigational New Drug (IND) application, which has been accepted for review, to the U.S. Food and Drug Administration (FDA) for Berubicin in the treatment of Glioblastoma Multiforme (GBM). The Company plans to evaluate the efficacy of Berubicin in a Phase 2 Trial for adults with GBM who have failed first-line therapy and commence the trial within the first quarter of 2021, pending the FDA’s acceptance of the Company’s filing.
“Our laser focus from the beginning has been to start the next phase of the investigation of Berubicin for the treatment of this deadly disease as quickly as possible,” commented John Climaco, CEO of CNS Pharmaceuticals. “Our team has worked tirelessly for the past year, making several inroads on our manufacturing and clinical efforts to achieve this important milestone. We believe we are optimally positioned to continue to execute our plan and initiate our Phase 2 trial in the first quarter of 2021. We continue to build on the positive results Berubicin demonstrated in the Phase 1 study in high grade gliomas and look forward to advancing its clinical development in these patients, with the end goal of addressing the unmet medical need of better treatment for patients diagnosed with GBM.”
The planned Phase 2 trial will evaluate the efficacy of Berubicin in patients with GBM who have failed primary treatment for their disease, and results will be compared to the current standard of care, with 2 to 1 randomization of the 243 patients to Berubicin or Lomustine. The trial will include an interim analysis that will evaluate the comparative effectiveness of these treatments. The trial’s adaptive design is intended to allow this interim analysis of the data to demonstrate meaningful differences in efficacy between treatments and then to allow an adjustment to the size of the patient population in the trial for maximum efficiency in terms of time in development. Based on this, the trial has the potential to provide data to the FDA that may allow an expedited pathway for development. However, there can be no assurance that the FDA will support any potential request for an expedited pathway to approval or further development.
About CNS Pharmaceuticals, Inc.
CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. related to a completed Phase 1 clinical trial with Berubicin in malignant brain tumors, which Reata conducted in 2006. In this trial the overall response rate of stable disease or better was 44%. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of Feb. 20, 2020. These Phase 1 results represent a limited patient sample size and, while promising, are not a guarantee that similar results will be achieved in subsequent trials. By the end of 2020, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland. Its second drug candidate, WP1244, is a novel DNA binding agent that has shown in preclinical studies that it is 500 times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.
For more information, please visit www.CNSPharma.com.
Forward-Looking Statements
Some of the statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to seek accelerated approval from the FDA of a New Drug Application (NDA) following the planned Berubicin trial. These statements relate to future events, future expectations, plans and prospects. Although CNS believes the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including those discussed under Item 1A. “Risk Factors” in CNS’s most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in its Form 10-Q filings and in its other public filings with the SEC. Any forward-looking statements contained in this press release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
CONTACTS:
Investor Relations Contact
James Salierno
The Ruth Group
646-536-7028
Media Contact
Annika Parrish
The Ruth Group
(720) 412-9042
Corporate Communications:
InvestorBrandNetwork (IBN)
Los Angeles, California
www.InvestorBrandNetwork.com
310.299.1717 Office
Editor@InvestorBrandNetwork.com
SOURCE: CNS Pharmaceuticals, Inc.
Dr. Wen’s appointment bolsters the Company’s neuro-oncology expertise in preparation for upcoming clinical trials of Berubicin in glioblastoma
Houston, TX – August 27, 2020) – CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) (“CNS” or the “Company”), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announces Patrick Wen, M.D., a professor of neurology at Harvard Medical School and director of the Center for Neuro-Oncology at Dana-Farber Cancer Institute, has joined the Company’s Science Advisory Board.
“We are excited to add Dr. Wen, a neuro-oncologist with a passion for and background in investigating cures for deadly brain cancers, such as glioblastoma, to our Science Advisory Board,” commented John Climaco, CEO of CNS Pharmaceuticals. “We believe Dr. Wen’s extensive experience in the field of neuro-oncology will prove invaluable as we continue to prepare for our upcoming Berubicin clinical trials. The addition of Dr. Wen strongly complements our strategy to further drive the development of Berubicin as we look forward to initiating our Phase I pediatric and Phase II adult studies in Poland and our Phase II trial in the U.S.”
Dr. Wen is an accomplished neuro-oncologist with a proven track record of treating brain tumors and neurologic complications of cancer. He graduated from the Medical College of St. Bartholomew’s Hospital, University of London, and completed his internal medicine training at the University of London postgraduate hospitals. Subsequently, Dr. Wen completed his neurology residency in the Harvard-Longwood Neurology Training Program. He is currently a professor of neurology at Harvard Medical School and a director of the Center for Neuro-Oncology at Dana-Farber.
As previously announced, CNS Pharmaceuticals recently engaged USA-based Pharmaceutics International, Inc. (Pii) and Italian BSP Pharmaceuticals SpA (BSP) for the production of the Berubicin drug product. The Company decided to implement a dual-track drug product manufacturing strategy to mitigate COVID-19-related risks, diversify its supply chain, and provide for localized availability of Berubicin. CNS has completed synthesis of Berubicin active pharmaceutical ingredient (API) and has shipped API to both manufacturers to prepare an injectable form of Berubicin for clinical use.
About CNS Pharmaceuticals, Inc.
CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. related to a completed Phase 1 trial with Berubicin in GBM, which Reata conducted in 2006. In this trial, 44% of patients experienced a statistically significant improvement in progression-free survival. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of Feb. 20, 2020. By the end of 2020, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland. The Company’s second drug candidate, WP1244, is a novel DNA binding agent that has shown in preclinical studies that it is 500 times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.
Forward-Looking Statements
Some of the statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to initiate its Phase 2 trial by the end of 2020. These statements relate to future events, future expectations, plans and prospects. Although CNS believes the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology, including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including those discussed in the Company’s SEC filings, including under Item 1A. “Risk Factors” in the Company’s most recently filed Form 10-K, filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in the Company’s Form 10-Q filings and in its other public filings with the SEC. Any forward-looking statements contained in this press release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
CONTACTS:
Investor Relations Contact
James Salierno / Kait Brosco
The Ruth Group
646-536-7028 / 7032
jsalierno@theruthgroup.com
kbrosco@theruthgroup.com
Media Contact
Kirsten Thomas
The Ruth Group
(508) 280-6592
kthomas@theruthgroup.com
Source: CNS Pharmaceuticals, Inc.
Selects Worldwide Clinical Trials as Contract Research Organization Partner
Houston, TX – August 20, 2020 – CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) (“CNS” or the “Company”), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announced it has engaged Worldwide Clinical Trials (“Worldwide”) as the contract research organization (“CRO”) for its upcoming Berubicin clinical trials.
Worldwide is a a full-service, midsize, global CRO that provides drug development services to biopharmaceutical companies in clinical trials. Worldwide specializes in therapeutic areas where there remain unmet medical needs, including CNS disorders and oncology. Worldwide provides proactive insight and operational support and has successfully managed clinical trials across more than 60 countries.
“Designing and operating trials in areas of high unmet medical need, such as glioblastoma, is a challenging and complex task for any company. We are excited to bring on a high caliber partner such as Worldwide, which has extensive expertise in CNS and oncology, as our CRO for the upcoming Berubicin clinical trials,” commented John Climaco, CEO of CNS Pharmaceuticals. “Engaging Worldwide is one of the key pieces of our preparations. We maintain that their insight and unparalleled experience in trials of this nature provide the best opportunity to further drive Berubicin’s clinical development. We believe that with Worldwide’s deep clinical CNS and oncology experience, and through our achievements in trial preparation, we are optimally positioned for our upcoming Phase II Berubicin trials in adults in the US and Poland as well as our Phase I pediatric trial.”
“The relationship between CNS Pharmaceuticals and Worldwide exemplifies state-of-the-art strategic program development – innovative program design coupled to exceptional clinical and operational acumen for a compound that offers considerable promise to both adults as well as children with such devastating illnesses,” commented Michael F. Murphy, MD, PhD, Chief Medical and Scientific Officer at Worldwide. “Speaking on behalf of our organization, it is a privilege to express our personal and professional commitment to its success.”
The Company’s decision to engage Worldwide as its CRO for the upcoming Berubicin clinical trials is the latest milestone in a series of recent preparation achievements. The Company has been active in implementing its strategic plan and engaged US-based Pharmaceutics International, Inc., (Pii) and Italy-based BSP Pharmaceuticals S.p.A., (BSP) for the production of Berubicin drug product. The decision to add both Pii and BSP as manufacturers of Berubicin was part of the Company’s strategy to implement a dual-track drug product manufacturing strategy. The Company believes this dual-track strategy will help mitigate COVID-19 related risks, diversify its supply chain, and provide for localized availability of Berubicin. Furthermore, CNS completed synthesis of Berubicin Active Pharmaceutical Ingredient (API) and shipped API to both manufacturers to prepare an injectable form of Berubicin for clinical use.
About CNS Pharmaceuticals, Inc.
CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. related to a completed Phase 1 clinical trial with Berubicin in malignant brain tumors which Reata conducted in 2006. In this trial, 44% of patients experienced a statistically significant improvement in clinical benefit. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of February 20, 2020. By the end of 2020, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland. Its second drug candidate, WP1244, is a novel DNA binding agent that has shown in preclinical studies that it is 500-times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.
About Worldwide Clinical Trials
Worldwide Clinical Trials employs more than 1,700 professionals around the world, with offices in North and South America, Eastern and Western Europe, Russia, and Asia. Founded by physicians committed to advancing medical science, Worldwide is out to change how the world experiences CROs—in the best possible way. From early phase and bioanalytical sciences through late phase, post-approval and real-world evidence, we provide world-class, full-service drug development services.
With infrastructure and talent spanning 60 countries, we execute predictable, successful studies with operational excellence across a range of therapeutic areas, including central nervous system, cardiovascular, metabolic, general medicine, oncology and rare diseases. We never compromise on science or safety. We’re never satisfied with the status quo. We’re the Cure for the Common CRO.
Forward-Looking Statements
Some of the statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to initiate its Phase 2 trial by the end of 2020. These statements relate to future events, future expectations, plans and prospects. Although CNS believes the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including those discussed in the Company’s SEC filings, including under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this press release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
CONTACTS:
Investor Relations Contact
James Salierno
The Ruth Group
(646) 536-7028
Media Contacts
Kirsten Thomas
The Ruth Group
(508) 280-6592
Lindsey Johnson
Worldwide Clinical Trials
(484) 832-1059
Source: CNS Pharmaceuticals, Inc.
Houston, TX – July 15, 2020 – CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) (“CNS” or the “Company”), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today provided an update on the manufacturing strategy for Berubicin drug product, its lead drug candidate for the treatment of glioma brain tumors.
In June, CNS Pharmaceuticals successfully engaged USA-based Pharmaceutics International, Inc., (Pii) and Italian BSP Pharmaceuticals S.p.A., (BSP), respectively, for the production of Berubicin drug product. The Company decided to implement a dual-track drug product manufacturing strategy in order to mitigate both COVID-19 related risks, as well as to diversify its supply chain and reduce the risk that inefficiencies could impact the Company’s clinical timeline. The Company’s decision to have both a European and United States manufacturer also provides for localized availability of Berubicin for the upcoming Phase I Pediatric and Phase II adult studies in Poland and the U.S. Phase II trial. As previously announced, CNS completed synthesis of Berubicin Active Pharmaceutical Ingredient (API) and has now shipped API to two companies, Pii and BSP, that will prepare an injectable form of Berubicin ready for clinical use. This is an important step to allow CNS to initiate clinical studies in GBM patients.
“Our decision to contract both Pii and BSP represents a key part of our overall strategy to get Berubicin back into clinical trials as soon as possible,” stated John Climaco, CEO of CNS Pharmaceuticals. “Importantly, we felt it prudent to diversify our production strategy given the difficulty of predicting COVID-19 related risks and supply chain constraints. With our laser focus on initiating our Phase 2 trial by the end of the 2020, we believe the decision to engage both manufacturers positions us optimally to continue to execute on our timeline and reduce the risks of delays.”
About CNS Pharmaceuticals, Inc.
CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. related to a completed Phase 1 trial with Berubicin in GBM which Reata conducted in 2006. In this trial, 44% of patients experienced a statistically significant improvement in progression-free survival. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of February 20, 2020. By the end of 2020, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland. Its second drug candidate, WP1244, is a novel DNA binding agent that has shown in preclinical studies that it is 500-times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.
Forward-Looking Statements
Some of the statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to initiate its Phase 2 trial by the end of 2020. These statements relate to future events, future expectations, plans and prospects. Although CNS believes the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including those discussed in the Company’s SEC filings, including under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this press release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
CONTACTS:
Investor Relations Contact
James Salierno / Kait Brosco
The Ruth Group
646-536-7028 / 7032
Media Contact
Kirsten Thomas
The Ruth Group
(508) 280-6592
Source: CNS Pharmaceuticals, Inc
Houston, TX – July 8, 2020 – CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) (“CNS” or the “Company”), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, announced today it has completed shipping its Active Pharma Ingredient (API) to both Maryland based Pharmaceutics International, Inc., (Pii) and Italian BSP Pharmaceuticals S.p.A., (BSP), respectively, for the production of Berubicin.
“As we continue to prepare for our upcoming Berubicin Phase 2 trial, ensuring proper manufacturing and delivery of drug product is a key priority,” stated John Climaco, CEO of CNS Pharmaceuticals. “We are excited to execute on yet another key milestone, and deliver Berubicin’s API to our trusted partners PII and BSP. We will continue our focus on executing upon all of the necessary steps as we look to pave the way for our upcoming U.S. Phase 2 trial, expected to initiate during the fourth quarter of this year.”
CNS previously entered into manufacturing contracts with Pii and BSP for the production of Berubicin, its lead drug candidate for the treatment of glioma brain tumors. The decision to implement a binary manufacturing strategy mitigates COVID-19 related manufacturing risks for the upcoming Phase I study in Poland and the upcoming U.S. Phase 2 trial. The first API shipments to PII and BSP commenced in June.
About CNS Pharmaceuticals, Inc.
CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. related to a completed Phase 1 trial with Berubicin in GBM which Reata conducted in 2006. In this trial, 44% of patients experienced a statistically significant improvement in progression-free survival. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of February 20, 2020. In the second half of 2020, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland. Its second drug candidate, WP1244, is a novel DNA binding agent that has shown in preclinical studies that it is 500-times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.
Forward-Looking Statements
Some of the statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to initiate its Phase 2 trial in the fourth quarter of this year. These statements relate to future events, future expectations, plans and prospects. Although CNS believes the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including those discussed in the Company’s SEC filings, including under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this press release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
CONTACTS:
Investor Relations Contact
James Salierno / Kait Brosco
The Ruth Group
646-536-7028 / 7032
Media Contact
Kirsten Thomas
The Ruth Group
(508) 280-6592
Source: CNS Pharmaceuticals, Inc.
Houston, TX – April 23, 2020 – CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) (“CNS” or the “Company”), a biotechnology company specializing in the development of novel treatments for brain tumors, today announced it has filed an application with the U.S. Food and Drug Administration (FDA) to receive Orphan Drug Designation (ODD) for its lead product Berubicin.
Under a prior developer, Berubicin, then known as RTA 744, was granted ODD by the FDA for the treatment of malignant gliomas. In the prior developer’s Phase 1 trial of Berubicin, 44% of the patients demonstrated a significant improvement in progression free survival. Additionally, one patient in this study experienced a complete response to his treatment with Berubicin.
“We are excited to announce the Orphan Drug application submission for Berubicin, as it would grant special status and accelerate the development of Berubicin to treat glioblastoma, one of the world’s most aggressive forms of cancer,” stated John Climaco, CEO of CNS Pharmaceuticals. “We are pleased to continue to execute upon our strategic initiatives and submit our application within the anticipated timeline outlined within our previous filings. We feel cautiously optimistic about the application, given the past Orphan Drug Designation of the molecule and positive Phase 1 results. We look forward to initiating a Phase II trial evaluating the effect of Berubicin on patients with glioblastoma later this year.”
The Orphan Drug Act (“ODA”) provides for granting special status to a drug or biological product to treat a rare disease or condition upon request of a sponsor. This status is referred to as orphan designation (or sometimes “orphan status”).
The FDA grants Orphan Drug Designation status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics. The FDA defines rare diseases as those affecting fewer than 200,000 people in the United States at any given time. Due to small patient numbers, treatment for these rare diseases would not be considered economically feasible without government programs to support their economic viability. Orphan Drug Designation would qualify Berubicin for certain benefits and incentives, including seven years of marketing exclusivity if regulatory approval is ultimately received for the designated indication, potential tax credits for certain activities, eligibility for orphan drug grants, and the waiver of certain administrative fees. The receipt of Orphan Drug Designation status does not change the regulatory requirements or process for obtaining marketing approval.
About Berubicin
Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin treatment of brain cancer patients appeared to demonstrate positive responses that include one durable complete response in a Phase 1 human clinical trial conducted by Reata.
About CNS Pharmaceuticals, Inc.
CNS Pharmaceuticals is a biotechnology company specializing in the development of novel treatments for primary and metastatic brain and central nervous system tumors. Its lead candidate Berubicin is proposed for the treatment of glioblastoma, a type of brain cancer currently considered incurable, as well as for pancreatic and ovarian cancers, and lymphomas. The Company entered into an intellectual property (IP) agreement with Houston Pharmaceuticals, Inc. and a Purchase Agreement with Reata. For more information, visit www.cnspharma.com.
Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to receive orphan drug designation for Berubicin and to commence Phase II trials of Berubicin this year. These statements relate to future events, future expectations, plans and prospects. Although CNS believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under in our SEC filings, including under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
Investor Relations Contact
James Salierno / Kait Brosco
The Ruth Group
646-536-7028 / 7032
jsalierno@theruthgroup.com
kbrosco@theruthgroup.com
Media Contact
Kirsten Thomas
The Ruth Group
(508) 280-6592
kthomas@theruthgroup.com
Source: CNS Pharmaceuticals, Inc.
CNS Pharmaceuticals to receive 50% of net sales on resulting anti-viral commercial products, including WP1122, in certain international markets
Houston, TX – April 13, 2020 – CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) (“CNS” or the “Company”), a biotechnology company specializing in the development of novel treatments for brain tumors, announced that independent research by the University of Frankfurt found 2-deoxy-D-glucose (“2-DG”) to reduce replication of SARS-CoV-2, the virus that causes COVID-19, by 100% in in vitro testing.
Researchers at the University of Frankfurt disclosed the findings in their article submitted to NatureResearch on March 11, 2020 (Bojkova, D et al; DOI: 10.21203/rs.3.rs-17218/v1) (https://www.researchsquare.com/article/rs-17218/v1). The authors reported that inhibiting glycolysis with non-toxic concentrations of 2-DG completely prevented SARS-CoV–2 replication in Caco–2 cells. Glycolysis is a process by which cells convert glucose into energy and infected (host) cells are induced by viruses to dramatically increase their dependence on glycolysis. 2-DG inhibits glycolysis because, although it appears to cells to be glucose, it is in fact a decoy that cannot be converted into energy.
As previously announced, CNS entered into an agreement with WPD Pharmaceuticals Inc. (CSE: WBIO), for the development of several preclinical drug candidates including WP1122. WP1122, which is being tested on a range of viruses including the coronavirus SARS-CoV-2, is a prodrug of the glucose decoy called 2-deoxy-D-glucose, or 2-DG. While the free form of 2-DG is rapidly metabolized and ineffective within minutes of entering the body, WP1122 has a much longer half-life, potentially enabling it to deliver quantities adequate for a therapeutic effect. WPD Pharmaceuticals previously licensed rights to a portfolio of drug candidates, including WP1122, from Moleculin Biotech, Inc. for certain territories.
“We are extremely encouraged by this breakthrough discovery of WP1122’s potential efficacy in fighting COVID-19,” commented John M. Climaco, CEO of CNS Pharmaceuticals. “We believe these findings represent a significant catalyst and incentive to expedite the development of WP1122. We look forward to working closely with WPD Pharmaceuticals to continue the advancement of the WP1122 program toward a potential life-saving treatment for this deadly disease, the death toll from which is nearly 100,000 lives worldwide this year and climbing every hour.”
Under the CNS Agreement, WPD will receive a portion of the development costs from CNS for WP1122 and other drug candidates for antiviral indications, and CNS will receive certain economic rights. WPD received an upfront cash payment from of $225,000 and CNS has committed to a milestone payment of $775,000 upon the successful completion of a Phase 2 study. In return for the funding, CNS is entitled to receive 50% of the net sales, less WPD’s license costs, of resulting commercial products in WPD’s licensed territories, other than Poland. Those territories include 29 countries in Europe and Asia, including Russia.
About CNS Pharmaceuticals, Inc.
CNS Pharmaceuticals is a biotechnology company specializing in the development of novel treatments for primary and metastatic brain and central nervous system tumors. Its lead candidate Berubicin is proposed for the treatment of glioblastoma, a type of brain cancer currently considered incurable, as well as for pancreatic and ovarian cancers, and lymphomas. The Company entered into an intellectual property (IP) agreement with Houston Pharmaceuticals, Inc. and a Purchase Agreement with Reata. For more information, visit www.cnspharma.com.
Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of WPD to develop the drug candidates subject to the development agreement. These statements relate to future events, future expectations, plans and prospects. Although CNS believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under in our SEC filings, including under the heading “Risk Factors” in the Form S-1 we filed with the SEC on October 7, 2019. Any forward-looking statements contained in this release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
Investor Relations Contact
James Salierno / Kait Brosco
The Ruth Group
646-536-7028 / 7032
Media Contact
Kirsten Thomas
The Ruth Group
(508) 280-6592
Source: CNS Pharmaceuticals, Inc.
Testing of drug candidate WP1122 to be done by leading Government funded research institution specializing in infectious diseases including COVID-19
Vancouver, BC – March 24, 2020 – WPD Pharmaceuticals Inc. (CSE: WBIO)(FSE: 8SV1) (the “Company” or “WPD”) a clinical stage pharmaceutical company, announces it has entered into a development agreement (the “Agreement”) with CNS Pharmaceuticals, Inc. (“CNS”)(NASDAQ:CNSP) for the development of several preclinical drug candidates including WP1122, which will be tested on a range of viruses including the coronavirus SARS-CoV-2.
WPD has licensed rights to a portfolio of drug candidates, including WP1122, through its license partner, Moleculin Biotech, Inc. (“Moleculin”)(NASDAQ:MBRX). Recently, Moleculin entered into an agreement with a leading government funded research facility in the United States to conduct research on its patented portfolio of molecular inhibitors, including drug candidate, WP1122, for antiviral properties against a range of viruses, including Coronavirus. WP1122 is a prodrug of 2-DG (2-deoxy-D-glucose) that, based on recently developed preclinical data, appears to overcome 2-DG’s lack of drug-like properties and is able to significantly improve tissue/organ concentration.
Under the CNS Agreement, WPD will receive a portion of the development costs from CNS for WP1122 and other drug candidates for antiviral indications, and CNS will receive certain economic rights. WPD received an upfront cash payment from of $225,000 and CNS has committed to a milestone payment of $775,000 upon the successful completion of a Phase 2 study. In return for the funding, CNS is entitled to receive 50% of the net sales of resulting commercial products in WPD’s 31 licensed territories, but Poland may become exempted from the list on certain milestones being achieved. Those 31 territories include countries in Europe and Asia, and include Russia.
Mariusz Olejniczak, CEO of WPD commented, “We look forward to partnering with CNS through this Agreement for the development of antiviral drug candidates, including WP1122. We are grateful to be able to join forces with them and help the urgent fight against deadly viral infections such as the coronavirus that causes Covid-19.”
The Company also announces it has retained 1157667 BC Ltd. as corporate advisors and has granted them 500,000 options at $0.86.
About WPD Pharmaceuticals
WPD is a biotechnology research and development company with a focus on oncology, namely research and development of medicinal products involving biological compounds and small molecules. WPD has 10 novel drug candidates with 4 that are in clinical development stage. These drug candidates were researched at institutions including the Mayo Clinic and Emory University, and WPD currently has ongoing collaborations with Wake Forest University and leading hospitals and academic centers in Poland.
WPD has entered into license agreements with Wake Forest University Health Sciences and sublicense agreements with Moleculin Biotech, Inc. and CNS Pharmaceuticals, Inc., respectively, each of which grant WPD an exclusive, royalty-bearing sublicense to certain technologies of the licensor. Such agreements provide WPD with certain research, development, manufacturing and sales rights, among other things. The sublicense territory from CNS Pharmaceuticals and Moleculin Biotech includes 31 countries in Europe and Asia, including Russia.
On Behalf of the Board
‘Mariusz Olejniczak’
Mariusz Olejniczak
CEO, WDP Pharmaceuticals
Contact:
Investor Relations
Email: investors@wpdpharmaceuticals.com
Tel: 604-428-7050
Web: www.wpdpharmaceuticals.com
Cautionary Statements:
Neither the Canadian Securities Exchange nor the Investment Industry Regulatory Organization of Canada accepts responsibility for the adequacy or accuracy of this release.
This press release contains forward-looking statements. Forward-looking statements are statements that contemplate activities, events or developments that the Company anticipates will or may occur in the future. These forward-looking statements include that we will use the funds from CNS to help the urgent fight against coronavirus and that we can attain all the additional funding of $775,000. Factors which may prevent the forward looking statement from being realized is that we don’t reach milestones required and don’t receive any additional funds from CNS; that our research does not result in any advance against viral diseases; that competitors or others may successfully challenge a granted patent and the patent could be rendered void; that we are unable to raise sufficient funding for our research; that we may not meet the requirements to receive the grants awarded; that our drugs don’t provide positive treatment, or if they do, the side effects are damaging; competitors may develop better or cheaper drugs; and we may be unable to obtain regulatory approval for any drugs we develop. Readers should refer to the risk disclosure included from time-to-time in the documents the Company files on SEDAR, available at www.sedar.com. Although the Company believes that the assumptions inherent in these forward-looking statements are reasonable, they are not guarantees of future performance and, accordingly, they should not be relied upon and there can be no assurance that any of them will prove to be accurate. Finally, these forward-looking statements are made as of the date of this press release and the Company assumes no obligation to update them except as required by applicable law.
Source: WPD Pharmaceuticals Inc.
Houston, TX – March 23, 2020 – CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) (“CNS” or the “Company”), a biopharmaceutical company primarily specializing in the development of novel treatments for cancers of the brain and central nervous system, announces it has entered into an agreement with WPD Pharmaceuticals Inc. (CSE: WBIO) for the development of several preclinical drug candidates including WP1122, which is being tested on a range of viruses including the coronavirus SARS-CoV-2. WPD Pharmaceuticals previously licensed rights to a portfolio of drug candidates, including WP1122, from Moleculin Biotech, Inc. for certain territories. WPD Pharmaceuticals was founded by Dr. Waldemar Priebe, the founder of the Company.
According to WPD Pharmaceuticals, WP1122 is a prodrug of 2-DG (2-deoxy-D-glucose) that, based on recently developed preclinical data, appears to overcome 2-DG’s lack of drug-like properties and is able to significantly increase tissue/organ concentration.
“We are pleased to expand our relationship with WPD Pharmaceuticals and to broaden our product pipeline to include antiviral drug candidates,” commented John M. Climaco, CEO of CNS Pharmaceuticals. “While our primary focus remains in oncology, given our expertise in working with compounds like WP1122 we are grateful to be able to help in the urgent fight against deadly viral infections such as the coronavirus that causes Covid-19. This agreement complements our existing clinical programs by expanding our potential market opportunities.”
Under the terms of the agreement, CNS agreed to fund a portion of the development costs of WP1122 and other drug candidates for antiviral indications in exchange for certain economic rights. CNS made an upfront cash payment of $225,000 and committed to a milestone payment of $775,000 to WPD Pharmaceuticals upon the successful completion of a Phase 2 study. In return, CNS is entitled to receive 50% of the net sales, less WPD’s license costs, of resulting commercial products in WPD’s licensed territories, other than Poland. Those territories include 29 countries in Europe and Asia, including Russia.
About CNS Pharmaceuticals, Inc.
CNS Pharmaceuticals is developing novel treatments primarily for cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of GBM, an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals related to a completed Phase 1 trial with Berubicin in GBM which Reata conducted in 2006. In this trial, 44% of patients experienced a statistically significant improvement in progression-free survival. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of February 2020. In the second half of 2020, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland. Its second drug candidate, WP1244, is a novel DNA binding agent that has been shown in preclinical studies to be 500-times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation. For more information, please visit www.cnspharma.com.
Forward-Looking Statements
Some of the statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of WPD Pharmaceuticals to develop the drug candidates subject to the development agreement. These statements relate to future events, future expectations, plans and prospects. Although CNS believes the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including those discussed in the Company’s SEC filings, including under the heading “Risk Factors” in the Form S-1 filed on October 7, 2019. Any forward-looking statements contained in this press release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
CONTACTS:
CNS Pharmaceuticals
Christopher S. Downs, CFO
(646) 734-5383
or
LHA Investor Relations
Yvonne Briggs
(310) 691-7100
Source: CNS Pharmaceuticals, Inc
Phase 2 Clinical Trials to Begin subject to FDA IND Approval
Houston, TX – March 3, 2020 – CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) (“CNS” or the “Company”), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, announces as of February 2020, a patient from the Phase 1 clinical trial for the treatment of glioblastoma multiforme (“GBM”), conducted by Reata Pharmaceuticals, Inc., remains cancer free. GBM is an aggressive type of brain cancer and, currently, there are no effective therapies approved to treat this disease.
In the Phase 1 trial, 44% of patients experienced a statistically significant improvement in progression-free survival. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response, which is defined by the National Cancer Institute as the disappearance of all signs of cancer in response to treatment. This initial trial was conducted in 2006 and as of February 2020, the patient has remained cancer free for over 13 years.
“We are delighted to provide this update on Berubicin’s potential capabilities given the unmet need for this aggressive disease,” commented John M. Climaco, Chief Executive Officer of CNS Pharmaceuticals. “We are looking forward to initiating our Phase 2 clinical trial in the second half of this year with our partner, WPD Pharmaceuticals, Inc. In addition, we expect WPD Pharmaceuticals, Inc. to commence a first-ever Phase 1 trial in children later this year. As previously announced, the pediatric trial will be conducted at Children’s Memorial Health Institute, the largest pediatric hospital in Poland.” WPD Pharmaceuticals, Inc. was founded by Dr. Waldemar Priebe, the founder of the Company.
About Berubicin
Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin treatment of brain cancer patients appeared to demonstrate positive responses that include one durable complete response in a Phase 1 human clinical trial conducted by Reata Pharmaceuticals, Inc.
About CNS Pharmaceuticals, Inc.
CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of GBM, an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. related to a completed Phase 1 trial with Berubicin in GBM which Reata conducted in 2006. In this trial, 44% of patients experienced a statistically significant improvement in progression-free survival. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of February 20, 2020. In the second half of 2020, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland. Its second drug candidate, WP1244, is a novel DNA binding agent that has been shown in preclinical studies to be 500-times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation. For more information, please visit www.cnspharma.com.
Forward-Looking Statements
Some of the statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to initiates its Phase 2 clinical trial in the second half of this year, and the ability of WPD Pharmaceuticals to commence a Phase 1 trial in children later this year. These statements relate to future events, future expectations, plans and prospects. Although CNS believes the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including those discussed in the Company’s SEC filings, including under the heading “Risk Factors” in the Form S-1 filed on October 7, 2019. Any forward-looking statements contained in this press release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
CONTACTS:
CNS Pharmaceuticals
Christopher S. Downs, CFO
(646) 734-5383
or
LHA Investor Relations
Yvonne Briggs
(310) 691-7100
Source: CNS Pharmaceuticals, Inc.
In addition to potential upcoming Phase II clinical trial evaluating the efficacy of Berubicin in patients with Glioblastoma
Houston, TX – February 11, 2020 – CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) (“CNS” or the “Company”), a biotechnology company specializing in the development of novel treatments for brain tumors, today announced its plan to initiate a Phase I clinical trial for Berubicin in pediatric brain cancer in Poland in collaboration with WPD Pharmaceuticals, Inc. (CSE: WBIO) (“WPD”), a Polish corporation founded by Dr. Waldemar Priebe, the founder of the Company.
The Company, in collaboration with WPD, will conduct the upcoming Phase I clinical trial at Children’s Memorial Health Institute (“Children’s Memorial”), the largest pediatric hospital in Poland. The Company believes this Phase I trial of Berubicin at Children’s Memorial represents the first ever investigation of an anthracycline and topoisomerase II inhibitor in pediatric brain tumors. WPD and CNS are currently working with Children’s Memorial to complete documentation for the upcoming study and EMA scientific advice meeting.
As previously announced, CNS entered into a sublicense agreement with WPD which granted WPD commercial rights in a limited territory to Berubicin, including research and development. Subsequently, WPD was awarded a $6 million grant from the EU/Polish National Center for Research and Development. WPD plans to utilize funds from the grant to fund the upcoming Phase I trial and CNS is committed to fully support these studies with its internal expertise.
“We are extremely excited to further expand the scope of Berubicin and potentially bring a new hope for pediatric brain tumor patients in Poland and subsequently around the world,” stated John Climaco, CEO of CNS Pharmaceuticals. “We look forward to initiating what we believe to be the first investigation of a unique topoisomerase II inhibitor that appears to be able to cross the blood-brain barrier in pediatric brain tumors as we continue to drive the clinical development of Berubicin in the upcoming Phase II trial in adult patients.”
About Berubicin
Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin treatment of brain cancer patients appeared to demonstrate positive responses that include one durable complete response in a Phase 1 human clinical trial conducted by Reata.
About CNS Pharmaceuticals, Inc.
CNS Pharmaceuticals is a biotechnology company specializing in the development of novel treatments for primary and metastatic brain and central nervous system tumors. Its lead candidate Berubicin is proposed for the treatment of glioblastoma, a type of brain cancer currently considered incurable, as well as for pancreatic and ovarian cancers, and lymphomas. The Company entered into an intellectual property (IP) agreement with Houston Pharmaceuticals, Inc. and a Purchase Agreement with Reata. For more information, visit www.cnspharma.com.
Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to further the clinical development of Berubicin in the United States and Poland. These statements relate to future events, future expectations, plans and prospects. Although CNS believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under in our SEC filings, including under the heading “Risk Factors” in the Form S-1 we filed with the SEC on October 7, 2019. Any forward-looking statements contained in this release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
Investor Relations Contact
James Salierno / Kait Brosco
The Ruth Group
646-536-7028 / 7032
Media Contact
Kirsten Thomas
The Ruth Group
(508) 280-6592
Source: CNS Pharmaceuticals, Inc.
Houston, TX – January 28, 2020 – CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) (“CNS” or the “Company”), a biotechnology company specializing in the development of novel treatments for brain tumors, today announced that Anthem Biosciences of Bangalore, India (Anthem) has completed a pilot run of the recrystallization of the Reata Pharmaceuticals, Inc. API (Reata). It has also completed a lyophilization of the API. Samples of the drug product, which include 299 capped vials have been shipped to Intertek Pharmaceutical Services (Intertek) for further analysis and release.
As previously announced, the FDA agreed in a preclinical submission that CNS could use Reata API as long as it was reprocessed and released under GMP conditions, and that the new lyophilized form of the drug product could be used during the Company’s upcoming clinical trial. Anthem, a full-service provider of GMP manufacturing for APIs, completed this pilot run of the Reata API. The pilot run recrystallization passed all specifications at Intertek. The recrystallized API was shipped to Lyophilization Technology, Inc. a leader of GMP lyophilization of Drug Products for clinical trials, which completed a pilot lyophilization. The pilot run of lyophilized API was successfully tested and released by Intertek. DavosPharma, a Davos Chemical Company, acted on behalf of the Company as the coordinating manufacturing broker for all of these processes.
“We are excited to achieve another important milestone in the development of Berubicin,” stated John Climaco, CEO of CNS Pharmaceuticals. “We look forward to completing both GMP manufacturing processes and release for clinical trials.”
About Berubicin
Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin treatment of brain cancer patients appeared to demonstrate positive responses that include one durable complete response in a Phase 1 human clinical trial conducted by Reata.
About CNS Pharmaceuticals, Inc.
CNS Pharmaceuticals is a biotechnology company specializing in the development of novel treatments for primary and metastatic brain and central nervous system tumors. Its lead candidate Berubicin is proposed for the treatment of glioblastoma, a type of brain cancer currently considered incurable, as well as for pancreatic and ovarian cancers, and lymphomas. The Company entered into an intellectual property (IP) agreement with Houston Pharmaceuticals, Inc. and a Purchase Agreement with Reata. For more information, visit www.cnspharma.com.
Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to receive a COA for the GMP reprocessed API, and to achieve the large-scale production of Berubicin. These statements relate to future events, future expectations, plans and prospects. Although CNS believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under in our SEC filings, including under the heading “Risk Factors” in the Form S-1 we filed with the SEC on October 7, 2019. Any forward-looking statements contained in this release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
Investor Relations Contact
James Salierno / Kait Brosco
The Ruth Group
646-536-7028 / 7032
Media Contact
Kirsten Thomas
The Ruth Group
(508) 280-6592
Source: CNS Pharmaceuticals, Inc.
This Additional Production Will Ensure Availability Through the Completion of its Upcoming Phase II Clinical Trials
Houst, TX – January 14, 2020 – CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) (“CNS” or the “Company”), a biotechnology company specializing in the development of novel treatments for brain tumors, today announced it has signed a contract with NCK A/S for the large scale production of Berubicin, its lead drug candidate for the treatment of glioma brain tumors.
NCK A/S is a GMP manufacturer of complex drugs located in Farum, Denmark, and the previous producer of Berubicin for Reata Pharmaceuticals. Production of large scale Berubicin is set to commence in January and will ensure drug availability through the end of Phase II clinical trials for glioblastoma.
“We are extremely excited to have entered into a contract with NCK A/S. We believe working with an experienced company in the production of this class of anthracyclines is paramount given the complex chemistry and difficulty to produce very high purity for human use,” stated John Climaco, CEO of CNS Pharmaceuticals. “We are confident in NCK A/S’ ability to succeed in the large scale production of our lead candidate due to its extensive experience in Berubicin synthesis for previous clinical trials. This contract represents a key stride in the development of Berubicin and secures drug availability as we look forward not only to initiate but also expand Phase II clinical trials later this year.”
About Berubicin
Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin was developed at the MD Anderson Cancer Center (MDACC), which is the top ranked cancer center in the US, and largest cancer research and treatment facility in the world. Berubicin treatment of brain cancer patients appeared to demonstrate positive responses that include one durable complete response in a Phase 1 human clinical trial conducted by Reata.
About CNS Pharmaceuticals, Inc.
CNS Pharmaceuticals is a biotechnology company specializing in the development of novel treatments for primary and metastatic brain and central nervous system tumors. Its lead candidate Berubicin is proposed for the treatment of glioblastoma, a type of brain cancer currently considered incurable, as well as for pancreatic and ovarian cancers, and lymphomas. The Company entered into an intellectual property (IP) agreement with Houston Pharmaceuticals, Inc. and a Purchase Agreement with Reata. For more information, visit www.cnspharma.com.
Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to prepare its IND and to commence its upcoming potential Phase II study. These statements relate to future events, future expectations, plans and prospects. Although CNS believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under in our SEC filings, including under the heading “Risk Factors” in the Form S-1 we filed with the SEC on October 7, 2019. Any forward-looking statements contained in this release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
Investor Relations Contact
James Salierno / Kait Brosco
The Ruth Group
646-536-7028 / 7032
jsalierno@theruthgroup.com
kbrosco@theruthgroup.com
Media Contact
Kirsten Thomas
The Ruth Group
(508) 280-6592
kthomas@theruthgroup.com
SOURCE: CNS Pharmaceuticals, Inc.
Houston, TX – January 13, 2020 – CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) (“CNS” or the “Company”), a biotechnology company specializing in the development of novel treatments for brain tumors, today announced it has entered into a licensing agreement with MD Anderson to investigate WP1244, an entirely new class of DNA-binding agents designed to cross the blood brain barrier for the potential the treatment of primary and metastatic brain cancers.
This agreement marks the Company’s first direct relationship with MD Anderson, the largest cancer research and treatment institute in the world, and allows for the continued development of WP1244, a new class of DNA-binding agents shown to have high anti-tumor activity. WP1244 was designed using a “modular” strategy, which combines intercalation and groove-binding modes into molecules with the requisite chirality and binding-site size to impart meaningful selectivity. Previous pre-clinical tests have demonstrated the agent’s ability to cross the blood barrier in animal models with no acute clinically observable toxicity. The Company is currently collaborating with MD Anderson on terms to conduct a sponsored research agreement of this novel class of agent.
“Our licensing agreement with MD Anderson has allowed CNS to double its portfolio with the addition of WP1244. We are extremely excited to continue the investigation of this entirely new class of DNA-binding agent in our first direct relationship with MD Anderson,” stated CEO of CNS, John M. Climaco. “We believe the compound demonstrates enormous potential through its novel mechanism of action, ability to cross the blood-brain barrier, and tremendous potency, 500 times that of classic DNA binding agents such as daunorubicin. WP1244 has shown to be mechanistically and biologically novel and selective, and its addition to our pipeline furthers our goal of being the leading developer of organ-targeted cancer therapeutics. We look forward to both furthering the clinical development of WP1244 and deepening our relationship with MD Anderson through a sponsored research agreement.”
About WP1244
WP1244 is a novel DNA binding agent with relatively high molecular weight (981.3 MW) having a polyamide moiety attached to the amino sugar. WP1244 is exceedingly potent having in vitro IC50 values in the subnanomolar range and is currently being studied for its therapeutic potential in preclinical studies. A previous 5-mice pilot study performed with WP1244 confirmed the presence of WP1244 in murine brain tissue. WP1244 was designed utilizing a “modular” design strategy, which combines intercalation and groove-binding modes into molecules with the requisite chirality and binding-site size to impart meaningful selectivity. Pre-clinical studies of WP1244 have demonstrated its potential ability to cross the blood-brain barrier in animal models. WP1244 was developed at the MD Anderson Cancer Center in the Department of Experimental Therapeutics as a collaborative effort with the Neuro-Oncology Department and Pharmaceutical Development Center.
About CNS Pharmaceuticals, Inc.
CNS Pharmaceuticals is a biotechnology company specializing in the development of novel treatments for primary and metastatic brain and central nervous system tumors. Its lead candidate Berubicin is proposed for the treatment of glioblastoma, a type of brain cancer currently considered incurable, as well as for pancreatic and ovarian cancers, and lymphomas. The Company entered into an intellectual property (IP) agreement with Houston Pharmaceuticals, Inc. and a Purchase Agreement with Reata. For more information, visit www.cnspharma.com.
Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to further the clinical development of WP1244. These statements relate to future events, future expectations, plans and prospects. Although CNS believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under in our SEC filings, including under the heading “Risk Factors” in the Form S-1 we filed with the SEC on October 7, 2019. Any forward-looking statements contained in this release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
Investor Relations Contact
James Salierno / Kait Brosco
The Ruth Group
646-536-7028 / 7032
jsalierno@theruthgroup.com
kbrosco@theruthgroup.com
Media Contact
Kirsten Thomas
The Ruth Group
(508) 280-6592
kthomas@theruthgroup.com
Source: CNS Pharmaceuticals, Inc.
Houston, TX – December 17, 2019 – CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) (“CNS” or the “Company”), a biotechnology company specializing in the development of novel treatments for brain tumors, today announced the completed good manufacturing practice (GMP) reprocessing of its lead drug candidate, Berubicin, with partner Anthem Biosciences Pvt. Ltd. of Banglaore, India, (“Anthem”) an internationally recognized Contract Research and Innovation Service Provider specializing in complex medicinal chemistry.
This critical manufacturing step was undertaken pursuant to previously announced positive feedback from the U.S. Food and Drug Administration (FDA) for the Company’s Pre-IND (Investigational New Drug) meeting proposal to use a lyophilized drug product, Berubicin, in Phase II clinical trials.
In its response to the Company’s Pre-IND request, the FDA agreed that CNS’ proposal to use a lyophilized drug product, that was developed previously but not used clinically, is acceptable. The FDA further stated that the Company’s proposal to utilize its existing supply of Berubicin in its proposed Phase 2 clinical trial was reasonable if the Berubicin was reprocessed by batch GMP recrystallization and released under GMP specifications. In response to the FDA’s guidance, CNS contracted with Anthem and completed the GMP reprocessing of CNS’ existing supply of Berubicin.
“We are thankful to have such an experienced partner, Anthem, assist us in completing the critical reprocessing work of our existing Berubicin supply,” stated CEO of CNS, John M. Climaco. “The GMP reprocessing was a significant milestone in our continued efforts to prepare a new IND in accordance with the FDA guidance we received. We look forward to our upcoming potential Phase II trial evaluating the efficacy of Berubicin in subjects who have glioblastoma that has recurred or progressed following radiation therapy and temozolomide, as we believe in Berubicin’s potential to demonstrate in clinical trials that it can become the only effective anthracycline against brain cancer.”
About Berubicin
Berubicin is an anthracycline, a class of drugs among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to damage the DNA of targeted cancer cells by interfering with the action of the topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin was developed at the MD Anderson Cancer Center (MDACC), the world’s largest cancer research facility. Berubicin appeared to demonstrate one Durable Complete Response in a Phase I human clinical trial conducted by a prior developer.
About CNS Pharmaceuticals, Inc.
CNS Pharmaceuticals is a biotechnology company specializing in the development of novel treatments for primary and metastatic brain and central nervous system tumors. Its lead candidate Berubicin is for the treatment of glioblastoma, a type of brain cancer currently considered incurable, as well as pancreatic and ovarian cancers, and lymphomas. The Company entered into an IP agreement with Houston Pharmaceuticals, Inc. and a Purchase Agreement with Reata Pharmaceuticals, Inc. For more information, visit www.cnspharma.com
Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to prepare its IND and to reprocess its existing supply of Berubicin ahead of its upcoming potential Phase II study. These statements relate to future events, future expectations, plans and prospects. Although CNS believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under in our SEC filings, including under the heading “Risk Factors” in the Form S-1 we filed with the SEC on October 7, 2019. Any forward-looking statements contained in this release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
Investor Relations Contact
James Salierno / Kait Brosco
The Ruth Group
646-536-7028 / 7032
Media Contact
Kirsten Thomas
The Ruth Group
(508) 280-6592
Source: CNS Pharmaceuticals, Inc.
Houston, TX – December 11, 2019 – CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) (“CNS” or the “Company”), a biotechnology company specializing in the development of novel treatments for brain tumors, announced that its partner, WPD Pharmaceuticals (“WPD”), a Polish corporation founded by Dr. Waldemar Priebe, the founder of the Company, was awarded a $5,798,875 grant from the EU/Polish National Center for Research and Development under the Smart Growth Operational Program 2014-2020 (the “EU Grant”).
The Company previously entered into a sublicense agreement with WPD, in which WPD committed to a $2.0 million minimum expenditure on the development, testing, regulatory approval, and commercialization of Berubicin over a three –year period. WPD’s subsequent development project, “New approach to glioblastoma treatment addressing the critical unmet medical need” (the “WPD Project”), received the grant co-financed by the European Union under the Smart Growth Operational Program 2014-2020, Priority I: Support for Research and Development work by Enterprises, Measure 1.2: Sectorial Research and Development Programs, Sectorial Program InnoNeuroPharm. The main goal of the WPD Project is to implement the world’s first multicenter pediatric Phase I clinical trial to determine maximum tolerated dose (MTD) and Phase IB and II clinical trials in adults, to assess the efficacy of Berubicin. Proceeds from the grant will be used independently by WPD Pharmaceuticals in order to fulfill its commitment arising from its sublicense agreement with the Company.
“The EU Grant represents an important milestone for the advancement of our novel anthracycline, Berubicin, especially in pediatric settings,” commented CEO of CNS, John M. Climaco. “We believe this grant will allow our partner, WPD Pharmaceuticals, to fulfill its commitment arising from its sublicense agreement with us in a manner that is capital-efficient and non-dilutive to the CNS. Additionally, this EU Grant and our partnership with WPD presents an opportunity to potentially accelerate our efforts to bring Berubicin to patients around the world.”
About Berubicin
Berubicin is an anthracycline, a class of drugs among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to damage the DNA of targeted cancer cells by interfering with the action of the topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin was developed at the MD Anderson Cancer Center (MDACC), the world’s largest cancer research facility. Berubicin appeared to demonstrate one Durable Complete Response in a Phase I human clinical trial conducted by a prior developer.
About CNS Pharmaceuticals, Inc.
CNS Pharmaceuticals is a biotechnology company specializing in the development of novel treatments for primary and metastatic brain and central nervous system tumors. Its lead candidate Berubicin is for the treatment of glioblastoma, a type of brain cancer currently considered incurable, as well as pancreatic and ovarian cancers, and lymphomas. The Company entered into an IP agreement with Houston Pharmaceuticals, Inc. and a Purchase Agreement with Reata Pharmaceuticals, Inc. For more information, visit www.cnspharma.com
Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of WPD to ultimately receive awarded grant funding and to conduct clinical trials to determine the maximum tolerated dose and to determine the efficacy of Berubicin in adults and the ability of WPD to spend the required minimum expenditure. These statements relate to future events, future expectations, plans and prospects. Although CNS believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under in our SEC filings, including under the heading “Risk Factors” in the Form S-1 we filed with the SEC on October 7, 2019. Any forward-looking statements contained in this release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
Investor Relations Contact
James Salierno / Kait Brosco
The Ruth Group
646-536-7028 / 7032
Media Contact
Kirsten Thomas
The Ruth Group
(508) 280-6592
Source: CNS Pharmaceuticals, Inc.
Houston, TX – December 10, 2019 – CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) (“CNS” or the “Company”), a biotechnology company specializing in the development of novel treatments for brain tumors, received positive feedback from the U.S. Food and Drug Administration (FDA) for its Pre-IND (Investigational New Drug) meeting proposal to use a lyophilized drug product, Berubicin, in Phase II clinical trials.
In its positive response to the Company’s previously submitted Pre-IND request, the FDA indicated that the proposal to use a lyophilized drug product in the Phase II clinical trial appears reasonable. The FDA recommended that the existing supply of Berubicin be reprocessed by batch recrystallization. Furthermore, the FDA noted that the requested dosage regimen, which will be based on the Reata Phase I trial, was reasonable. The Company plans to reprocess its existing supply of Berubicin ahead of its upcoming potential Phase II study.
“We were encouraged by the initial feedback provided by the FDA as we believe the availability of our existing supply of Berubicin for a Phase II trial represents significant costs savings and eliminates excess risk and time,” stated CEO of CNS, John M. Climaco. “We are continuing the process of preparing a new IND in accordance with the guidance we received from the FDA. We look forward to our upcoming potential Phase II trial evaluating the efficacy of Berubicin in subjects who have glioblastoma that has recurred or progressed following radiation therapy and temozolomide as we believe in Berubicin’s potential to offer oncologists the only anthracycline effective against brain cancer.”
About Berubicin
Berubicin is an anthracycline, a class of drugs among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to damage the DNA of targeted cancer cells by interfering with the action of the topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin was developed at the MD Anderson Cancer Center (MDACC), the world’s largest cancer research facility. Berubicin appeared to demonstrate one Durable Complete Response in a Phase I human clinical trial conducted by a prior developer.
About CNS Pharmaceuticals, Inc.
CNS Pharmaceuticals is a biotechnology company specializing in the development of novel treatments for primary and metastatic brain and central nervous system tumors. Its lead candidate Berubicin is for the treatment of glioblastoma, a type of brain cancer currently considered incurable, as well as pancreatic and ovarian cancers, and lymphomas. The Company entered into an IP agreement with Houston Pharmaceuticals, Inc. and a Purchase Agreement with Reata Pharmaceuticals, Inc. For more information, visit www.cnspharma.com
Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to prepare its IND and to reprocess its existing supply of Berubicin ahead of its upcoming potential Phase II study . These statements relate to future events, future expectations, plans and prospects. Although CNS believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under in our SEC filings, including under the heading “Risk Factors” in the Form S-1 we filed with the SEC on October 7, 2019. Any forward-looking statements contained in this release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
Investor Relations Contact
James Salierno / Kait Brosco
The Ruth Group
646-536-7028 / 7032
Media Contact
Kirsten Thomas
The Ruth Group
(508) 280-6592
Source: CNS Pharmaceuticals, Inc.
Houston, TX – November 26, 2019 – CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) (“Company”), a biotechnology company specializing in the development of novel treatments for brain tumors, entered into a sublicense agreement with WPD Pharmaceuticals (“WPD”), a Polish corporation partially owned and controlled by Dr. Waldemar Priebe, the founder of the Company. The agreement grants WPD patent rights to research and develop, and manufacture or sell Berubicin in a limited territory comprised mainly of Eastern Europe and Central Asia. The Company is entitled to a 1% royalty on all commercial sales of Berubicin in these licensed territories.
As part of the agreement, WPD committed to a $2.0 million minimum expenditure on the development, testing, regulatory approval, and commercialization of Berubicin during the three year term of the agreement, which ends in August 2021. WPD plans to implement a multicenter pediatric Phase I clinical trial to determine maximum tolerated dose, and to determine the efficacy of Berubicin in Phase IB and II clinical trials in adults. WPD also plans to conduct preclinical tests to determine the prospective use of Berubicin with temozolomide and with other compounds as anticancer drugs.
“We were extremely excited to enter into an agreement with WPD and to further explore the potential of Berubicin as an anthracycline internationally,” commented CEO of CNS, John M. Climaco. “Our agreement with WPD is truly a testament to our unrelenting commitment to pursuing treatments for glioblastoma around the world.”
About Berubicin
Berubicin is an anthracycline, a class of drugs among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to damage the DNA of targeted cancer cells by interfering with the action of the topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin was developed at the MD Anderson Cancer Center (MDACC), the world’s largest cancer research facility. Berubicin appeared to demonstrate one Durable Complete Response in a Phase I human clinical trial conducted by a prior developer.
About CNS Pharmaceuticals Inc.
CNS Pharmaceuticals is a biotechnology company specializing in the development of novel treatments for primary and metastatic brain and central nervous system tumors. Its lead candidate Berubicin is for the treatment of glioblastoma, a type of brain cancer currently considered incurable, as well as pancreatic and ovarian cancers, and lymphomas. The Company entered into an IP agreement with Houston Pharmaceuticals, Inc. and a Purchase Agreement with Reata Pharmaceuticals Inc. For more information, visit www.cnspharma.com
Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of WPD to conduct clinical trials to determine the maximum tolerated dose and to determine the efficacy of Berubicin in adults, the ability of WPD to conduct preclinical tests to determine the prospective use of Berubicin with temozolomide and with other compounds as anticancer drugs, and the ability of WPD to spend the required minimum expenditure. These statements relate to future events, future expectations, plans and prospects. Although CNS believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under in our SEC filings, including under the heading “Risk Factors” in the Form S-1 we filed with the SEC on October 7, 2019. Any forward-looking statements contained in this release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
Investor Relations Contact
James Salierno / Kait Brosco
The Ruth Group
646-536-7028 / 7032
Media Contact
Kirsten Thomas
The Ruth Group
(508) 280-6592
Source: CNS Pharmaceuticals, Inc.
Houston, TX November 21, 2019 – CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) (“Company”), a biotechnology company specializing in the development of novel treatments for brain tumors, filed a Pre-IND meeting request for Berubicin for IV for the Treatment of Glioblastoma Multiforme to the US Food and Drug Administration Division of Oncology Products 2, Center for Drug Evaluation and Research.
In its request, the Company outlined its rationale for the continued investigation of the compound and detailed key questions for the FDA, including its permission to utilize the supply of Berubicin acquired from Reata Pharmaceuticals Inc. in the planned upcoming Phase II clinical trial. The company has performed a preliminary purity testing and analysis on Reata’s supply of Berubicin and verified that it is 99.9% pure.
“We believe that utilizing the supply of Berubicin we acquired from Reata could offer the Company significant costs savings and eliminate the excess risk and time associated with manufacturing complex drugs,” stated CEO of CNS, John M. Climaco.
About Berubicin
Berubicin is an anthracycline, a class of drugs among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to damage the DNA of targeted cancer cells by interfering with the action of the topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin was developed at the MD Anderson Cancer Center (MDACC), the world’s largest cancer research facility. Berubicin appeared to demonstrate one Durable Complete Response in a Phase I human clinical trial conducted by a prior developer.
About CNS Pharmaceuticals Inc.
CNS Pharmaceuticals is a biotechnology company specializing in the development of novel treatments for primary and metastatic brain and central nervous system tumors. Its lead candidate Berubicin is for the treatment of glioblastoma, a type of brain cancer currently considered incurable, as well as pancreatic and ovarian cancers, and lymphomas. The Company entered into an IP agreement with Houston Pharmaceuticals, Inc. and a Purchase Agreement with Reata Pharmaceuticals Inc. For more information, visit www.cnspharma.com
Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of CNS to apply for and receive orphan drug status for Berubicin. These statements relate to future events, future expectations, plans and prospects. Although CNS believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under in our SEC filings, including under the heading “Risk Factors” in the Form S-1 we filed with the SEC on October 7, 2019. Any forward-looking statements contained in this release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
Investor Relations Contact
James Salierno / Kait Brosco
The Ruth Group
646-536-7028 / 7032
Media Contact
Kirsten Thomas
The Ruth Group
(508) 280-6592
Source: CNS Pharmaceuticals, Inc.
Houston, TX – November 19, 2019 – CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) (“Company”), a biotechnology company specializing in the development of novel treatments for brain tumors, completed an agreement with Houston Pharmaceuticals, Inc. (“HPI”) to obtain the rights to a worldwide, exclusive royalty-bearing, license for the chemical compound commonly known as Berubicin.
CNS’ licensing agreement with HPI grants the Company the exclusive right to develop certain patented chemical compounds for use in the treatment of cancer globally. In its agreement with HPI, the Company acquired multiple U.S. patents for Berubicin. CNS intends to apply for orphan drug status for Berubicin with the FDA for the treatment of malignant glioma.
“We believe our acquisition of the rights to Berubicin represents an important milestone in our pursuit to develop therapies for the treatment of glioblastoma, a type of brain cancer which is currently considered incurable,” stated CEO of CNS, John M. Climaco, Esq. “Our agreement with HPI expands our IP protection and provides us with developmental protection worldwide while we seek orphan drug status. We are excited to continue the clinical development of Berubicin and believe its promising tolerability and efficacy results are a testament to its therapeutic potential as a novel anthracycline agent.”
About Berubicin
Berubicin is an anthracycline, a class of drugs among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to damage the DNA of targeted cancer cells by interfering with the action of the topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin was developed at the MD Anderson Cancer Center (MDACC), the world’s largest cancer research facility. Berubicin appeared to demonstrate one Durable Complete Response in a Phase I human clinical trial conducted by a prior developer.
About CNS Pharmaceuticals Inc.
CNS Pharmaceuticals is a biotechnology company specializing in the development of novel treatments for primary and metastatic brain and central nervous system tumors. Its lead candidate Berubicin is for the treatment of glioblastoma, a type of brain cancer currently considered incurable, as well as pancreatic and ovarian cancers, and lymphomas. The Company entered into an IP agreement with Houston Pharmaceuticals, Inc. and a Purchase Agreement with Reata Pharmaceuticals Inc. For more information, visit www.cnspharma.com
Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of CNS to apply for and receive orphan drug status for Berubicin. These statements relate to future events, future expectations, plans and prospects. Although CNS believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under in our SEC filings, including under the heading “Risk Factors” in the Form S-1 we filed with the SEC on October 7, 2019. Any forward-looking statements contained in this release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
Investor Relations Contact
James Salierno / Kait Brosco
The Ruth Group
646-536-7028 / 7032
Media Contact
Kirsten Thomas
The Ruth Group
(508) 280-6592
Source: CNS Pharmaceuticals, Inc.
Houston, TX – November 13, 2019 – CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) (“Company”), a pre-clinical stage biotechnology company specializing in the development of novel treatments for brain tumors, today announced the closing of its initial public offering of 2,125,000 shares of common stock at an initial public offering price of $4.00 per share. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by the Company, were $8.5 million. In addition, the Company has granted the underwriters a 45-day option to purchase up to an additional 318,750 shares of common stock at the initial price to the public less underwriting discounts and commissions. The Company’s common stock is listed on the NASDAQ Capital Market under the symbol CNSP.
The Benchmark Company, LLC acted as sole Book Running Manager for the offering.
A registration statement on Form S-1 (File No. 333-232443) relating to the shares was filed with the Securities and Exchange Commission (“SEC”) and became effective on November 7, 2019. The offering was made only by means of a prospectus. Copies of the final prospectus may be obtained from The Benchmark Company, LLC, Attn: Prospectus Department, 150 E 58th Street, 17th floor, New York, NY 10155, 212-312-6700, Email: prospectus@benchmarkcompany.com.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About Berubicin
Berubicin is an anthracycline, a class of drugs among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to damage the DNA of targeted cancer cells by interfering with the action of the topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin was developed at the MD Anderson Cancer Center (MDACC), the world’s largest cancer research facility. Berubicin appeared to demonstrate one Durable Complete Response in a Phase I human clinical trial conducted by a prior developer.
About CNS Pharmaceuticals, Inc.
CNS Pharmaceuticals is a pre-clinical stage biotechnology company specializing in the development of novel treatments for primary and metastatic brain and central nervous system tumors. Its lead candidate Berubicin is for the treatment of glioblastoma, a type of brain cancer currently considered incurable, as well as pancreatic and ovarian cancers, and lymphonas. The Company entered into an IP agreement with Houston Pharmaceuticals, Inc. and a Purchase Agreement with Reata Pharmaceuticals Inc. For more information, visit www.cnspharma.com
Investor Relations Contact
James Salierno / Kait Brosco
The Ruth Group
646-536-7000
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Media Contact
Kirsten Thomas
The Ruth Group
(508) 280-6592
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SOURCE CNS Pharmaceuticals, Inc.
About CNS Pharmaceuticals
CNS Pharmaceuticals is a pre-clinical stage biotechnology company specializing in the development of novel treatments for brain tumors.
Our lead drug, Berubicin, is an exciting discovery for the treatment of Glioblastoma Multiforme (GBM) and potentially for other CNS malignancies. Berubicin was first discovered at the MD Anderson Cancer Center, one of the largest cancer institutes in the world.
CNS has obtained a worldwide exclusive license to the Berubicin patent from Houston Pharmaceuticals, the original commercial holder of the Berubicin intellectual property.
CNS has also acquired all data and know-how related to the Phase 1 trial of Berubicin from Reata Pharmaceuticals, a multibillion dollar NASDAQ listed company. In 2017, CNS entered into a collaboration agreement with Reata to further advance the development of Berubicin.
In 2020, with the funding secured from our NASDAQ IPO, CNS will commence its Phase 2(a) clinical trial of Berubicin for the treatment of GBM.
CNS may also pursue the development of Berubicin to treat additional diseases, including pancreatic and ovarian cancers and lymphoma. CNS may also develop combination therapies that include Berubicin.
Berubicin
Based on human clinical trial data, our lead drug called Berubicin, which was developed at the M.D. Anderson Cancer Center, the largest cancer treatment and research institute in the world, has been shown to get across the blood brain barrier and kill brain tumor cells not reachable by other therapies. In other words, Berubicin may become an effective treatment against glioblastoma, the most aggressive type of brain cancer.
BERUBICIN PHASE I CLINICAL TRIAL
This is a scan of a patient’s glioblastoma in Berubicin’s Phase 1 clinical trial where 44% of the patients showed a clinical response. Berubicin is one of the first anthracycline’s that does not require a specific carrier to be able to cross over the blood brain barrier and get into the brain. None of the drugs that require carriers have been shown to be effective in humans.
What is Glioblastoma?
Glioblastoma is the most aggressive type of brain cancer, where the average survival is only 14 to 16 months after diagnosis – essentially a death sentence for those afflicted with it. Glioblastoma is the type of brain cancer that led to the death of Senator Ted Kennedy, Vice President Joe Biden’s son and most recently, the passing of Senator John McCain. It’s important to understand that there is currently no proven cure for this aggressive disease.
What are Anthracyclines?
Anthracyclines are among the most effective anticancer treatments ever developed, and have played a prominent role in the treatment of more types of cancer than any other class of chemotherapeutic agents. According to academic literature, Anthracyclines have demonstrated anti-tumor activity in a wide range of cancers including breast, stomach, uterine, ovarian, bladder, lung and hematological malignancies.
Source: https://cnspharma.com/
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