Palm Beach, FL – November 17, 2020 – With the increasing prevalence of brain cancer, rising aging population, and growing incidences of cancer via chemical exposure, the demand of diagnosis and treatment of brain tumors is steadily increasing. The diagnosis, treatments, therapeutics and drug segments are all projected to continue to rise at a significant pace over the next several years. A report from Industry Research concerning the diagnostic and treatment markets projected that the global Brain Tumor Diagnosis and Treatments market size is projected to reach US$ 590 million by 2026, from US$ 444.8 million in 2020, at a CAGR of 4.8% during 2021-2026… while another report from ResearchAndMarkets, focusing on the drugs market added that the global brain tumor drugs market, which was valued at about $2.4 billion in 2018, is expected to grow to $3.41 billion at a CAGR of 9.2% through 2022. Active biotech and pharma companies in the markets this week include CNS Pharmaceuticals, Inc. (NASDAQ: CNSP), Amarin Corporation plc (NASDAQ: AMRN), Alterity Therapeutics (NASDAQ: ATHE), Bristol Myers Squibb (NYSE: BMY), Novocure (NASDAQ: NVCR).
The ResearchAndMarkets report added: “The major driving factor responsible for the growth of Brain Tumor market is the increasing prevalence of Neurological Disorders, worldwide. Neurological Disorders are identified as one of the most prevalent disorders, due to longer life expectancy, increasing exposure to infections and sedentary lifestyle. In 2015, these disorders were ranked as the leading cause group of Disability Adjusted Life Years (DALYs), which is the number of years lost due to ill-health, disability or early death. For example, as per the North American Brain Tumor Society, around 700,000 people in the region were suffering from Brain Tumors in 2015, which increased by around 78,000 people in 2016. The increasing number of patients with neurological disorders including brain tumor, is leading to a rise in the demand for the drugs used in their treatment. Increasing use of targeted therapies is acting as a restraint on the Brain Tumor drugs market. Targeted cancer therapies are drugs or substances which block the growth of cancer by interfering with molecules that are more specifically involved in cancer cell progression than in normal cell activity. The goal of targeted cancer therapies is to eliminate cancerous cells in the body while leaving normal cells unharmed. By focusing on changes in the cell that are specific to cancer, this therapy may prove to be more effective than traditional chemotherapy and radiotherapy.”
CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) BREAKING NEWS: CNS Pharmaceuticals Announces FDA Filing of IND for its Brain Cancer Drug Berubicin – Expects to initiate Phase 2 trial during the first quarter of 2021 – CNS Pharmaceuticals, 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. Read this full release and more news for CNSP at: https://www.financialnewsmedia.com/news-cnsp/
Other recent developments in the biotech industry include:
Amarin Corporation plc (NASDAQ: AMRN) recently announced the presentation of REDUCE-IT® CABG at American Heart Association’s (AHA) Virtual Scientific Sessions 2020, being held virtually from November 13 – November 17, 2020, adding to the growing body of knowledge on the clinical impact of VASCEPA® (icosapent ethyl). These new analyses supported by Amarin were presented by Subodh Verma, M.D., Ph.D., FRCSC, Professor and Cardiac Surgeon at University of Toronto.
“The REDUCE-IT CABG analysis results are another piece of the puzzle when looking at the potential use of icosapent ethyl in the procedural setting,” commented Dr. Deepak L. Bhatt, M.D., M.P.H., Executive Director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital and Professor of Medicine at Harvard Medical School, principal investigator of REDUCE-IT. “The findings of benefit in at-risk patients with prior CABG are consistent with previously presented data on overall reductions in first and total coronary revascularization events, as well as in patients with prior percutaneous coronary interventions, and further strengthen the case for consideration of icosapent ethyl as an additional intervention for use by physicians to care for this patient population.”
Alterity Therapeutics (NASDAQ: ATHE) has recently announced the allowance of a new composition of matter patent by the United States Patent and Trademark Office (USPTO). The new patent is the product of in-house discovery research and is central to Alterity’s next generation drug development portfolio focussed on neurodegenerative diseases.
The patent, entitled “Compounds for and Methods of Treating Diseases” (Application No. 16/818,641), covers more than 150 novel pharmaceutical compositions that are designed to redistribute the labile iron implicated in Parkinson’s disease, Alzheimer’s disease and other neurodegenerative conditions. The patent, which was filed in March of 2020, underwent prioritized examination by the USPTO.
Bristol Myers Squibb (NYSE: BMY) recently announced the presentation of research across its hematology portfolio at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, which will take place virtually from December 5 to 8, 2020. Data from nearly 100 company-sponsored studies will be featured, reinforcing the depth and diversity of the company’s development program and commitment to discovering potential new options to treat patients with blood cancers and other serious hematologic diseases.
“Our purpose continues to be translating groundbreaking research across many hard-to-treat diseases and the nearly 100 studies being presented at this meeting illustrate our continued focus, with new modalities and different targets in our pipeline supporting the next waves of innovation in hematology,” said Samit Hirawat, M.D., executive vice president, chief medical officer, global drug development, Bristol Myers Squibb.
Novocure (NASDAQ: NVCR), a global oncology company working to extend survival in some of the most aggressive forms of cancer, recently announced that it has received the CE Mark for the NovoTTF-100L system from the Notified Body (TÜV). The application of the CE mark enables Novocure to commercialize the device as a first-line treatment in combination with pemetrexed and platinum-based chemotherapy for unresectable, locally advanced or metastatic, malignant pleural mesothelioma (MPM) in the European Union and Switzerland.
MPM is a rare cancer that has been strongly linked to asbestos exposure. More than 13,000 people are diagnosed with mesothelioma in Europe annually. The U.S. FDA approved the NovoTTF-100L System (known as Optune Lua in the U.S.) as a treatment for MPM in May 2019 under the Humanitarian Device Exemption (HDE) pathway. Optune Lua was the first treatment for MPM approved by the FDA in more than 15 years. Prior to the FDA approval of NovoTTF-100L, pemetrexed plus cisplatin was the only FDA-approved therapy for patients with unresectable MPM. Now having the CE mark for its MPM therapy in Europe, Novocure will begin commercialization and to identify and pursue pathways for reimbursement in selected markets.
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