Palm Beach, FL – May 27, 2020 – Multiple industry reports project that the global Glioblastoma multiforme (GBM) drugs market is expected 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. 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. Brain and other nervous system cancer is the 10th leading cause of death for men and women. The American Association of Neurological Surgeons site said that: “… 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. The mainstay of treatment for GBMs is surgery, followed by radiation and chemotherapy. Given the limitation of all current therapeutics (surgery, chemotherapy and/or radiation), development of novel approaches to treating glioblastoma remains a great unmet need.” Active biotech companies with recent developments include: Nascent Biotech, Inc. (OTCQB: NBIO), Bristol-Myers Squibb Company (NYSE: BMY), AstraZeneca PLC (NYSE: AZN), Merck & Co., Inc. (NYSE: MRK), Clovis Oncology, Inc. (NASDAQ: CLVS).
Another report from Grand View Research added: “Global glioblastoma multiforme treatment market is expected to witness significant growth over the forecast period owing to the rising incidence of oncology diseases and rising geriatric population base. According to U.S. National Cancer Institute GBM is considered as the most aggressive form of brain cancer which represents 15.4% of all primary brain tumors and about 60% – 75% of all astrocytoma and shows rapid growth rate of benign cells in the organ. Currently unavailable therapies and prognosis for the treatment of GBM is expected to impact the market growth positively through to 2022. Presence of the treatment options which do not increase the overall survival rate in patients such as surgical resection, which is followed by chemotherapy and radiotherapy, is another factor attributing towards the expected growth of this market. Moreover, the fact that glioma stem cells resist conventional treatments also raises urgent need for alternative treatment therapies for glioblastoma multiforme thus driving the market. Increasing R&D in gene therapy and molecular biotechnology for the treatment of CNS associated disorders and cancer is anticipated to fuel the market growth over the forecast period.”
Nascent Biotech, Inc. (OTCQB: NBIO) BREAKING NEWS: Nascent Biotech to begin Phase 1 Human Trials for Brain Cancer Drug – Nascent Biotech (the “Company” or “Nascent”) pleased to announce that the Company will soon begin Phase 1 clinical trials for a treatment of Brain Cancer, including, glioblastoma (GBM), the deadliest form of brain cancer.
The study will employ Nascent’s monoclonal, antibody, Pritumumab (“PTB”) and will be conducted in collaboration with a Southern CA Cancer Center as noted in their release which can be viewed at https://www.nascentbiotech.com/hoag-is-first-in-nation-to-test-innovative-antibody-brain-cancer-drug/
Nascent’s lead therapeutic asset, PTB, is a natural human antibody that works by binding to ectodomain vimentin (EDV), a protein expressed on the surface of epithelial cancers. The PTB antibody is used as a targeted immunotherapy, which unlike chemotherapy, targets only the cancer cells without damaging healthy cells.
Because EDV is found in a variety of cancers, these important clinical trials of PTB could have implications for a broad range of more common cancers, such as breast, colon and lung. The current Phase 1 trials have been uniquely designed to ultimately treat a variety of brain cancers from gliomas and other primary brain tumors to brain metastases and leptomeningeal cancers arising from breast, lung and other solid tumors.
Sean Carrick, CEO of Nascent Biotech, states, “Nascent is committed to opening this trial and delivering this promising treatment to patients afflicted with this devastating disease.“ Read this entire press release and more news for NBIO at: https://financialnewsmedia.com/news-nbio
Other industry developments from around the markets include:
Bristol-Myers Squibb Company (NYSE: BMY) recently announced that the European Medicines Agency (EMA) has validated its Marketing Authorization Applications (MAA) for both idecabtagene vicleucel (ide-cel, bb2121) and CC-486. Validation of each application confirms the respective submissions are complete and begins the EMA’s centralized review process.
The MAA for ide-cel, the company’s investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy co-developed with bluebird bio, Inc., is for the treatment of adult patients with multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. Ide-cel was granted Accelerated Assessment status by the EMA in March, reducing the maximum timeframe for review of the application to 150 days.
AstraZeneca PLC (NYSE: AZN) recently announced that LYNPARZA® (olaparib) has been approved in the US for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Patients will be selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA.
The approval by the US Food and Drug Administration (FDA) was based on results from the Phase III PROfound trial, which were published in the New England Journal of Medicine. Prostate cancer is the second most common cancer in men and despite an increase in the number of available therapies for men with mCRPC, five-year survival remains low. HRR gene mutations occur in approximately 20%-30% of patients with mCRPC.
Merck & Co., Inc. (NYSE: MRK) and Ridgeback Biotherapeutics LP, a closely held biotechnology company, recently announced that the companies have entered into a collaboration agreement to develop EIDD-2801, an orally available antiviral candidate currently in early clinical development for the treatment of patients with COVID-19.
“In addition to our efforts to develop potential vaccines to SARS-CoV-2, we have also been evaluating our own anti-viral assets and those from external sources for their potential to treat individuals with COVID-19,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “Clinical evaluation of EIDD-2801 in COVID-19 patients is just beginning, now that phase 1 studies have demonstrated that the compound is well-tolerated. Since preclinical studies demonstrate that EIDD-2801 has potent antiviral properties against multiple coronavirus strains including SARS-CoV-2, we are eager to advance the next phase of clinical studies as rapidly and responsibly as possible.”
Clovis Oncology, Inc. (NASDAQ: CLVS) recently announced that the U.S. Food and Drug Administration (FDA) approved Rubraca® (rucaparib) tablets for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. The FDA approved this indication under accelerated approval based on objective response rate (ORR) and duration of response (DOR) data from the multi-center, single arm TRITON2 clinical trial. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. The TRITON3 clinical trial is expected to serve as the confirmatory study for the Rubraca accelerated approval in mCRPC. Warning and precautions include myelodysplastic syndrome (MDS), acute myeloid leukemia (AML) and embryo-fetal toxicity.
“Standard treatment options for men with mCRPC have been limited to androgen receptor-targeting therapies, taxane chemotherapy, Radium-223 and sipuleucel-T,” said Wassim Abida, M.D., Medical Oncologist, Memorial Sloan Kettering Cancer Center, and Principal Investigator for the TRITON2 study. “Rubraca is the first in a class of drugs to become newly available to patients with mCRPC who harbor a deleterious BRCAmutation. Given the level and duration of responses observed with Rubraca in men with mCRPC and these mutations, it represents an important and timely new treatment option for this patient population.”
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