Clinical Trials Testing New Paradigms For Advanced Therapies Treating Metastatic Cancer Conditions

Financialnewsmedia.com News Commentary

PALM BEACH, Fl., Aug. 20, 2020 /PRNewswire/ -- Various reports on the global metastatic cancer treatment market all project continued growth in the next several years. One such report from Industry Research says that the global metastatic cancer treatment market size is projected to reach $52.6 billion by 2026, up from $50.2 million in 2020, at a CAGR of 4.4% during 2021-2026. Another report from Statista projects even higher revenues saying that the total global market for metastatic cancer treatment is estimated that the market will grow to almost $100 billion dollars by 2025. An article from the American Brain Tumor Association added: "The treatment is directed towards not only metastatic brain tumors but their symptoms as well. Longer survival, improved quality of life and stabilization of neurocognitive function for patients with brain metastasis is the goal of treatment. There have been numerous advances in the treatment of metastatic brain tumors in the last decade…"   Active biotech and pharma companies in the markets this week include CNS Pharmaceuticals, Inc. (NASDAQ: CNSP), Momenta Pharmaceuticals, Inc. (NASDAQ: MNTA), AbbVie (NYSE: ABBV), Bristol Myers Squibb (NYSE: BMY), Clovis Oncology, Inc. (NASDAQ: CLVS).

Another report from Future Market Insights said: "The global brain metastasis therapeutics market is driven by the increasing need of treatment for symptoms associated with brain metastasis. Also, the chemotherapeutic agents are known to be the primary tools for cancer treatment which are estimated to increase the overall brain metastasis therapeutic market. The increased prevalence of cancer that spread to the brain are also expected to drive the global metastasis therapeutics market."

CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) BREAKING NEWS:  CNS Pharmaceuticals Engages CRO For Phase 2 Berubicin Clinical Trials - Selects Worldwide Clinical Trials as Contract Research Organization Partner - 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 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.     Read this full release and more news for CNSP at:  https://www.financialnewsmedia.com/news-cnsp/     

Other recent developments in the biotech industry include:

Momenta Pharmaceuticals, Inc. (NASDAQ: MNTA) a biotechnology company focused on discovering and developing novel biologic therapeutics to treat rare immune-mediated diseases recently announced that it has entered into a definitive agreement for Johnson & Johnson (NYSE: JNJ) to acquire Momenta for $52.50 per share in an all-cash transaction, implying a fully-diluted equity value of $6.5 billion. The agreement was unanimously approved by the Boards of Directors of both Momenta and Johnson & Johnson.

"The agreement with J&J recognizes the value created by years of commitment and dedication to our mission by the many current and past Momenta employees. Programs such as nipocalimab have the potential to improve the lives of countless patients suffering from autoimmune and fetal maternal diseases," said Craig Wheeler, President and Chief Executive Officer of Momenta. "This acquisition provides strong value for our shareholders and ensures a level of investment in our exciting portfolio that will further enhance its potential for patients. I believe J&J is the right company to advance our portfolio of novel drug candidates for autoimmune and rare diseases. J&J's leadership in immunology, extensive capabilities, and global reach, as well as its alignment with our vision of pioneering therapies for complex diseases is a strong fit for our company and our portfolio."

AbbVie (NYSE: ABBV) recently announced the publication of results from the Phase 3 VIALE-A clinical study in patients with AML in the New England Journal of Medicine (NEJM). The study, which evaluated newly-diagnosed AML patients who had not yet been treated and were unable to tolerate traditional intensive chemotherapy, found that venetoclax in combination with azacitidine extended overall survival (OS) compared to azacitidine plus placebo. The manuscript titled was published in the August 13, 2020 issue of NEJM.

"The ability of venetoclax plus azacitidine to improve outcomes of newly-diagnosed AML patients unable to tolerate intensive chemotherapy represents a potentially practice-changing advance in AML treatment," said Courtney D. DiNardo, M.D., MSCE, Department of Leukemia, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center and the lead study investigator."

Bristol Myers Squibb (NYSE: BMY) and Dragonfly Therapeutics, Inc. ("Dragonfly"), recently announced that they have entered into a definitive agreement under which Bristol Myers Squibb will be granted the global exclusive license to Dragonfly's interleukin-12 (IL-12) investigational immunotherapy program, including its extended half-life cytokine DF6002. DF6002 is a monovalent IL-12 immunoglobulin Fc fusion protein proposed to achieve strong anti-tumor efficacy by establishing an inflammatory tumor microenvironment necessary for productive anti-tumor responses.

Under the agreement, Bristol Myers Squibb will become responsible for the development and any subsequent commercialization of DF6002 and its related products worldwide, including strategic decisions, regulatory responsibilities, funding, and manufacturing. Dragonfly will receive $475 million in near-term upfronts, and is eligible to receive performance-based development, regulatory and commercial milestone payments. In addition, Dragonfly will receive up to 24% royalties on worldwide net sales. The agreement is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.

Clovis Oncology, Inc. (NASDAQ: CLVS) recently announced that data from the Phase 2 TRITON2 study of Rubraca^® (rucaparib) for the treatment of metastatic castration-resistant prostate cancer (mCRPC) harboring BRCA1/2 mutations were published online in the Journal of Clinical Oncology. These results supported the May 2020 U.S. Food and Drug Administration (FDA) accelerated approval of Rubraca for the treatment of mCRPC patients who have a deleterious BRCA mutation (germline and/or somatic) and who have previously received androgen receptor-directed therapy and taxane-based chemotherapy.

"Through publication in this prestigious journal, we are pleased to be able to share more detail about this important study, which we believe will be helpful for physicians as they consider treatment options for their mCRPC patients," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "The TRITON2 data underscore Rubraca's role as a meaningful new treatment option for men with mCRPC and a deleterious germline or somatic BRCA mutation who have progressed on androgen receptor-directed therapy and taxane-based chemotherapy."

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