Palm Beach, FL – June 29, 2021 – Glioblastoma multiforme (GBM) is one of the areas where the research & development investments are high and where global studies are growing. Everyone is looking to solve the problem. GBM, a fast-growing and aggressive brain tumor, is a devastating brain cancer that can result in death in six months or less, if untreated; hence, it is imperative to seek expert neuro-oncological and neurosurgical care immediately, as this can impact overall survival. Brain and other nervous system cancer is the 10th leading cause of death for men and women. 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. According to iHealthcareAnaylist report, said that: “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 multiforme (GBM) is the most common and deadly brain tumor in adults. The incidence of GBM in the USA and Europe is 2–3 per 100,000. By definition, an orphan disease is one affecting 200,000 persons in the USA (one in every 1,500). In Europe, the definition is a bit narrower, with fewer than five in 10,000 (one in every 2,000) people affected.” The report said that: “ The global Glioblastoma multiforme (GBM) drugs market is projected to reach nearly $1.8 billion by 2027, expanding at a CAGR of 12.8% 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. “ Active biotech and pharma companies in the markets this week include CNS Pharmaceuticals, Inc. (NASDAQ: CNSP), Intellia Therapeutics, Inc. (NASDAQ: NTLA), Anavex Life Sciences Corp. (NASDAQ: AVXL), Bristol Myers Squibb (NYSE: BMY), Clovis Oncology, Inc. (NASDAQ: CLVS).
The iHealthcareAnaylist report continued: “A few agents have been approved by the US FDA for the treatment of high-grade gliomas following orphan drug designation, but most have failed to reach the market. However, a few patients may have benefited from receiving developmental agents within clinical trials. Biomarkers for selection of these patients may result in more success in the field of personalized medicine. The number of orphan drug designations seems to keep increasing, and cancer drugs represent the majority as compared with drugs for more traditional rare diseases. This may be seen as an indicator of the success of the Orphan Drug Act, which was initiated in 1983. Given the limitation of all current therapeutics (surgery, chemotherapy and/or radiation), development of novel approaches to treating glioblastoma remains a great unmet need.”
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:
Intellia Therapeutics, Inc. (NASDAQ: NTLA) and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) recently announced positive interim data from an ongoing Phase 1 clinical study of their lead in vivogenome editing candidate, NTLA-2001, which is being developed as a single-dose treatment for transthyretin (ATTR) amyloidosis. The Phase 1 study, run by Intellia as the program’s development and commercialization lead, is evaluating NTLA-2001 in people living with hereditary transthyretin amyloidosis with polyneuropathy (ATTRv-PN). NTLA-2001 is the first CRISPR/Cas9-based therapy candidate to be administered systemically, via intravenous infusion, for precision editing of a gene in a target tissue in humans. NTLA-2001 is designed to inactivate the TTR gene in liver cells to prevent the production of misfolded transthyretin (TTR) protein, which accumulates in tissues throughout the body and causes the debilitating and often fatal complications of ATTR amyloidosis. The interim data were presented today at the 2021 Peripheral Nerve Society (PNS) Annual Meeting and published in The New England Journal of Medicine.
“These are the first ever clinical data suggesting that we can precisely edit target cells within the body to treat genetic disease with a single intravenous infusion of CRISPR. The interim results support our belief that NTLA-2001 has the potential to halt and reverse the devastating complications of ATTR amyloidosis with a single dose,” said Intellia President and Chief Executive Officer John Leonard, M.D. “Solving the challenge of targeted delivery of CRISPR/Cas9 to the liver, as we have with NTLA-2001, also unlocks the door to treating a wide array of other genetic diseases with our modular platform, and we intend to move quickly to advance and expand our pipeline. With these data, we believe we are truly opening a new era of medicine.”
Anavex Life Sciences Corp. (NASDAQ: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) disorders, recently reported that the predictive biomarker of response established with SIGMAR1 mRNA expression correlates significantly with responses in primary and secondary clinical efficacy endpoints from the proof-of-concept randomized, double-blind, placebo-controlled Phase 2 trial that randomized 132 patients with Parkinson’s disease dementia equally (ratio of 1:1:1) to target doses of 30mg, 50mg ANAVEX®2-73 or placebo, respectively.
ANAVEX®2-73 activates the sigma-1 receptor (SIGMAR1). Data suggests that activation of SIGMAR1 results in the restoration of complete housekeeping function within the body and is pivotal to restoring neural cell homeostasis and promoting neuroplasticity. Recent independent findings strengthen the understanding of the beneficial effect of SIGMAR1 activation as compensatory mechanism to chronic CNS diseases.
Bristol Myers Squibb (NYSE: BMY) recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo (nivolumab) for the adjuvant treatment of adult patients with esophageal or gastroesophageal junction (GEJ) cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy (CRT). The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the CHMP recommendation.
“For many patients with localized esophageal or gastroesophageal junction cancer, the risk of recurrence is high, even after neoadjuvant chemoradiotherapy and surgery. This leaves patients in need of additional treatment options,” said Ian M. Waxman, M.D., development lead, gastrointestinal cancers, Bristol Myers Squibb. “We believe that the use of immunotherapy in earlier stages of cancer is important because of its potential to prevent recurrence. The CHMP’s positive recommendation for Opdivo as an adjuvant treatment for esophageal or gastroesophageal junction cancer represents a step forward for people living with these cancers as we see the science translate into outcomes.” The positive opinion is based on results from the Phase 3 CheckMate -577 trial which showed that treatment with Opdivofollowing neoadjuvant CRT and complete surgical resection doubled the primary endpoint of disease-free survival (DFS) compared to placebo in the all-randomized population. The safety profile of Opdivowas consistent with previously reported studies.
Clovis Oncology, Inc. (NASDAQ: CLVS) recently announced that Professor Dr. Richard P. Baum and Dr. Harshad R. Kulkarni, in conjunction with 3B Pharmaceuticals (Clovis’ licensing partner and discoverer of FAP-2286), published a retrospective report of their independent experience with FAP-2286 in named-patient use in The Journal of Nuclear Medicine. In the first named-patient experience of the investigational compound conducted at Zentralklinik, Bad Berka, Germany, patients were treated with the FAP-targeted radiotherapy FAP-2286 linked to the radionuclide lutetium-177 (177Lu) as a therapeutic agent after prior confirmation of tumor FAP-positivity in patients by PET/CT imaging.
In this palliative use setting, FAP-2286 was administered on a named-patient basis to 11 patients with progressive and metastatic adenocarcinoma of the pancreas, breast, rectum, and ovary after prior confirmation of FAP expression. According to the authors, administration of 177Lu-FAP-2286 demonstrated high uptake and long retention in primary and metastatic tumor lesions and an acceptable toxicity profile. The report concludes that the data warrant further investigation of 177Lu-FAP-2286 in clinical studies to systematically evaluate its safety and efficacy, and to define the patient population who would benefit most from treatment.
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