CNS Pharmaceuticals Announces Contract with International GMP Manufacturer for Production of Berubicin
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.”
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.
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.
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SOURCE: CNS Pharmaceuticals, Inc.