Palm Beach, FL – January 28, 2020 – Brain and other nervous system cancers are the 10th leading cause of death for men and women. The global Glioblastoma multiforme (GBM) drugs market to reach nearly $1.4 billion by 2025, expanding at a CAGR of 12.6% during the forecast period, driven by rising geriatric population, growing incidence cases and rich clinical pipeline of new products. GBMs are biologically aggressive tumors that present unique treatment challenges due to the localization of tumors in the brain, inherent resistance to conventional therapy, limited capacity of the brain to repair itself, migration of malignant cells into adjacent brain tissue, the variably disrupted tumor blood supply which inhibits effective drug delivery, tumor capillary leakage, resulting in an accumulation of fluid around the tumor and they have a limited response to therapy. The mainstay of treatment for GBMs is surgery, followed by radiation and chemotherapy. Active biotech and pharma companies in the markets this week include CNS Pharmaceuticals, Inc. (NASDAQ: CNSP), BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX), Clovis Oncology, Inc. (NASDAQ: CLVS), Achillion Pharmaceuticals, Inc. (NASDAQ: ACHN), Miragen Therapeutics, Inc. (NASDAQ: MGEN).
Globally, over 241,000 people die each year as a result of brain or nervous system cancer, with GBM being the most common form of the disease. GBM has an incidence of two to three per 100,000 adults per year, and accounts for 52 percent of all primary brain tumors. Glioblastoma is the most common primary malignant form of brain cancer. Despite technological advances in surgery and radio-chemotherapy, glioblastoma remains largely resistant to treatment. The standard treatment for glioblastoma is surgery. The choice of drug therapy for glioblastoma is still limited to a handful of compounds.
CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) BREAKING NEWS: CNS Pharmaceuticals Completes Pilot Manufacturing Steps Pursuant to FDA Pre-IND Guidance – CNS Pharmaceuticals, 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.” Read this and more news for CNSP at: https://www.financialnewsmedia.com/news-cnsp/
Other recent developments in the biotech industry include:
BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX) recently announced the appointments of Charles Gayer as chief commercial officer and Allen Hodge as vice president and general manager for the United States. Mr. Gayer joined BioCryst in 2015 as vice president of global strategic marketing. Since July 2019 he has served as interim chief commercial officer, playing a key role in defining the strategy, and building the commercial operations, to support the launch of berotralstat, BioCryst’s oral kallikrein inhibitor for hereditary angioedema (HAE).
Clovis Oncology, Inc. (NASDAQ: CLVS) recently announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) for Rubraca® (rucaparib) and granted priority review status to the application with a Prescription Drug User Fee Act (PDUFA) date of May 15, 2020. Clovis submitted the sNDA submission for rucaparib as a monotherapy treatment of adult patients with BRCA1/2-mutant recurrent, metastatic castrate-resistant prostate cancer in November 2019.
“Recently presented data suggests that Rubraca may play a meaningful role in the treatment of patients with BRCA1/2-mutant recurrent, metastatic castrate-resistant prostate cancer, and this filing represents an important milestone for Clovis as it brings us one step closer to potentially making this valuable therapy available,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology.
Achillion Pharmaceuticals, Inc. (NASDAQ: ACHN) recently announced that its shareholders have approved the acquisition of Achillion by Alexion Pharmaceuticals, Inc. (ALXN). Achillion continues to expect the transaction to close in the first half of 2020, subject to expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the “HSR Act”). Alexion and Achillion have not yet submitted their filings under the HSR Act, and currently anticipate doing so in January 2020.
“Today’s results represent an important milestone in completing our transaction with Alexion and becoming better positioned to more quickly bring new, innovative and life-changing drugs to market,” said Joe Truitt, President and Chief Executive Officer at Achillion.
Miragen Therapeutics, Inc. (NASDAQ: MGEN) recently announced that it will present new efficacy and safety data from its Phase 1 trial of cobomarsen in adult T-cell leukemia/lymphoma (ATLL) at the 12th Annual T-Cell Lymphoma Forum, which is being held in La Jolla, CA, from January 30th to February 1st.
In addition, miRagen will also participate in the 4th World Congress of Cutaneous Lymphomas, which is taking place from February 12th to 14th in Barcelona, Spain. During the conference, Dr. Foss will provide an encore presentation of the new ATLL data in the poster titled, “Phase I Trial of Cobomarsen, a miR-155 Inhibitor, in Patients with Aggressive HTLV-1 Associated ATLL: Disease Stabilization and Biomarker Analysis”.
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