Palm Beach, FL – June 29, 2021 – Cancer is a foremost public health problem globally and is the second leading cause of death in the United States. According to the National Brain Tumor Society, there are around 700,000 Americans living with primary brain cancer, and approximately 84,170 people are estimated to receive a primary brain tumor diagnosis in 2021. This market entails drugs used to treat the human brain for the mass growth of abnormal cells. Depending on the size, type, and location of the tumor, such drugs are either used alone or in combinations. On the other hand, the burden of the rising prevalence of oncological diseases and the growing geriatric population globally is leading to a surge in the sales of products, as well as clinical trials in the global market. Moreover, initiatives taken by the government to enhance healthcare infrastructure, coupled with collaborative efforts by pharmaceutical companies, for spreading awareness about the availability of various therapies are expected to accelerate the market growth during the forecast period. Reports show that 2 markets in the brain tumor segment: The Brain Tumor Diagnostics and the Brain Tumor Drugs markets. Both are showing continued growth in the years to come. A report from ResearchAndMarkets said that: “The global market for Brain Tumor Diagnosis and Treatment estimated at US$537.5 Million in the year 2020, is projected to reach a revised size of US$887.5 Million by 2027, growing at a CAGR of 7.4% over the period 2020-2027…” Active biotech and pharma companies in the markets this week include CNS Pharmaceuticals, Inc. (NASDAQ: CNSP), MannKind Corporation (NASDAQ: MNKD), Iterum Therapeutics plc (NASDAQ: ITRM), Onconova Therapeutics, Inc. (NASDAQ: ONTX), Pfizer Inc. (NYSE: PFE).
While a report from Fortune Business Insights added that: “The global brain tumor drugs market size was USD 2.35 billion in 2020. Based on our analysis, the market exhibited a stellar growth of 18.4% in 2020. The market is expected to grow from USD 2.83 billion in 2021 to USD 5.64 billion in 2028 at a CAGR of 10.4% in the 2021-2028 period . The sudden decline in CAGR is attributable to this market’s demand and growth, returning to pre-pandemic levels once the pandemic is over.” The ResearchAndMarket report continued: “The U.S. Market is Estimated at $145.3 Million, While China is Forecast to Grow at 11.2% CAGR… The Brain Tumor Diagnosis and Treatment market in the U.S. is estimated at US$145.3 Million in the year 2020. China, the world`s second largest economy, is forecast to reach a projected market size of US$197 Million by the year 2027 trailing a CAGR of 11.2% over the analysis period 2020 to 2027.
CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) BREAKING NEWS: FDA Grants Fast Track Designation to CNS Pharmaceuticals for Berubicin for the Treatment of Recurrent Glioblastoma Multiforme – CNS Pharmaceuticals, a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for its lead investigational drug, Berubicin, for the treatment of patients with recurrent glioblastoma multiforme (GBM). As previously reported, the Company has also received Orphan Drug Designation from the FDA for Berubicin for the treatment of patients with recurrent GBM.
“Receiving Fast Track Designation from the U.S. FDA is a huge achievement in our advancement of Berubicin for the treatment of glioblastoma, the most aggressive, deadly and treatment-resistant type of cancer that forms in the brain. If there were ever a disease where the unmet clinical need demands action, it is GBM. Patients have almost no meaningful options and thousands lose their fight against this terrible cancer every year. With this designation, we now have an accelerated pathway to approval for Berubicin and a clear opportunity to more expediently bring this potentially impactful investigational therapy to individuals battling this challenging disease,” commented John Climaco, CEO of CNS Pharmaceuticals.
Fast Track Designation enables more frequent interactions with the FDA to expedite the development and review process for drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical need.
CNS recently announced the start of patient enrollment in its potentially pivotal study of Berubicin for the treatment of recurrent glioblastoma multiforme. For more information about this study, please visit ClinicalTrials.gov and reference Identifier NCT04762069. CONTINUED… Read this full release and more news for CNSP at: https://www.financialnewsmedia.com/news-cnsp/
Other recent developments in the biotech industry include:
MannKind Corporation (NASDAQ: MNKD) appreciates the recent efforts of the Centers for Medicare and Medicaid Services (CMS) in conjunction with the Medicare Administration Contractors (MACs) to implement a policy change to the Local Coverage Determination (LCD) L33822, allowing the approval to Medicare patients living with diabetes to select both Afrezza® and Continuous Glucose Monitors (CGMs). Effective July 18, the criteria change lifts the restriction on patients of having to choose between the two diabetes tools.
“Prior to this change, Medicare denials were occurring for patients using CGMs and inhaled insulin as an alternative to injected mealtime insulin,” explained Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. “MannKind is committed to providing convenience for patients, and believes that patients should have the choice to use any of today’s tools to help manage their diabetes.”
Iterum Therapeutics plc (NASDAQ: ITRM) recently announced that the Company recently participated in a late-cycle meeting with the U.S. Food and Drug Administration (“FDA”). During the meeting, the FDA shared issues still under review regarding the Company’s new drug application (“NDA”) for sulopenem etzadroxil/probenecid for the treatment of uncomplicated urinary tract infections in patients with a quinolone non-susceptible pathogen and the Company responded to these issues. The FDA has determined that an Advisory Committee meeting is not currently necessary. The review of the NDA is ongoing and the Company was informed that the FDA continues to work toward the PDUFA goal date of July 25, 2021.
Iterum Therapeutics plc is a clinical-stage pharmaceutical company dedicated to developing differentiated anti-infectives aimed at combatting the global crisis of multi-drug resistant pathogens to significantly improve the lives of people affected by serious and life-threatening diseases around the world. Iterum Therapeutics is advancing its first compound, sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development with an oral formulation and IV formulation. Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics. Iterum Therapeutics has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications.
Onconova Therapeutics, Inc. (NASDAQ: ONTX), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, recently announced an update on the investigator-initiated Phase 1/2a trial of oral rigosertib plus nivolumab in advanced metastatic KRAS mutated (KRAS+) non-small cell lung cancer (NSCLC). The clinical data to date provide preliminary evidence of potential anti-cancer activity of rigosertib-nivolumab combination therapy in advanced metastatic KRAS+ non-small cell lung cancer and show that the maximum tolerated dose of rigosertib in combination with nivolumab was not reached in the three cohorts of the trial’s dose-escalation phase. Patients enrolled in this trial have failed multiple lines of prior therapy and all have failed immune checkpoint inhibitors in various combinations.
The trial continues to recruit patients as part of the expansion phase at the highest dose of oral rigosertib defined in the current protocol. Based on the positive preliminary findings from the trial, a protocol amendment is being prepared that would allow for the evaluation of increased rigosertib doses in combination with the full dose of intravenous nivolumab, as recommended per its product label. “The preliminary results from this Phase 1/2a trial are very encouraging and demonstrate the potential of rigosertib to address a critical unmet medical need by overcoming checkpoint inhibitor resistance in KRAS mutated lung adenocarcinoma,” said Mark S. Gelder, M.D., Chief Medical Officer of Onconova.
Pfizer Inc. (NYSE: PFE) recently announced that the first participant has been dosed in TALAPRO-3, a global, randomized, double-blind, placebo-controlled Phase 3 clinical trial. The study will evaluate the efficacy and safety of talazoparib, an oral poly (ADP-ribose) polymerase (PARP) inhibitor, in combination with enzalutamide, an androgen receptor inhibitor, compared with placebo plus enzalutamide in men with DNA damage response (DDR)-deficient metastatic castration-sensitive prostate cancer (mCSPC). The first patient was dosed at a site in Glendale, California.
“The prognosis for men with advanced prostate cancer has significantly improved since the introduction of novel hormone therapies, but additional therapeutic options are needed for the approximately 25 percent of men with tumors harboring DNA damage response (DDR) gene mutations, who may have poorer outcomes,” said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology, Pfizer Global Product Development. “By combining enzalutamide, which has a proven clinical benefit in men with metastatic castration-sensitive prostate cancer, with talazoparib, our PARP inhibitor that is active in DDR-mutated cancer, we may be able to offer a new treatment option that targets the underlying genetic mechanisms associated with DDR-mutated mCSPC.”
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