Palm Beach, FL –December 17, 2019 – The success rate for cancer therapies has been limited due to a combination of factors, such as the treatment/drug’s lack of penetration through the blood brain barrier. Reports say that the global drug delivery across brain barrier market size is expected to reach USD 4.6 billion by 2026, according to a new report by Grand View Research, Inc. registering a CAGR of 30.2% over the forecast period. Growing research, innovation, and treatment development activities to overcome the challenges faced due to the natural blood brain barrier is majorly driving the market growth. In 2018 that blood brain barrier (BBB) market size was estimated at USD $582.0 million in 2018. Growing incidences of neurological disorders, such as Alzheimer’s disease, Parkinson’s disorder, Hunter’s syndrome, and brain tumor are anticipated to drive the market over the forecast period. The Grandview report stated: “Growing prevalence of neurological diseases, such as Parkinson’s and Alzheimer’s disease is fueling the demand for novel drug delivery technology that allows medication to cross the blood brain barrier. Limited treatment options regarding blood-brain barrier has been a big hurdle till recently. However, the growing demand for treatment and the rise in innovations that allow for safe and reliable transmission of medication across the BBB is predicted to drive the market’s growth over the forecast period. Active biotech and pharma companies in the markets this week include CNS Pharmaceuticals, Inc. (NASDAQ: CNSP), Amneal Pharmaceuticals, Inc. (NYSE: AMRX), Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM), Axsome Therapeutics, Inc. (NASDAQ: AXSM), Heron Therapeutics, Inc. (NASDAQ: HRTX).
Among the recently developed technologies, increasing permeability of the BBB via ultrasound is the most promising one that has shown safe and effective application in treating various patients with brain cancer and other neurogenetical disorders. Other novel technologies such as in-vitro BBB modeling/engineering is being used for producing a faster, reliable, and cost-effective drug delivery mechanism for overcoming the complexities of BBB.
CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) BREAKING NEWS: CNS Pharmaceuticals Partnered with Anthem Biosciences Pvt. Ltd. in Preparation for Upcoming Proposed Phase 2 Clinical Trial – CNS Pharmaceuticals, a biotechnology company specializing in the development of novel treatments for brain tumors, today announced the completed good manufacturing practice (GMP) reprocessing of its lead drug candidate, Berubicin, with partner Anthem Biosciences Pvt. Ltd. of Banglaore, India, (“Anthem”) an internationally recognized Contract Research and Innovation Service Provider specializing in complex medicinal chemistry.
This critical manufacturing step was undertaken pursuant to previously announced positive feedback from the U.S. Food and Drug Administration (FDA) for the Company’s Pre-IND (Investigational New Drug) meeting proposal to use a lyophilized drug product, Berubicin, in Phase II clinical trials.
In its response to the Company’s Pre-IND request, the FDA agreed that CNS’ proposal to use a lyophilized drug product, that was developed previously but not used clinically, is acceptable. The FDA further stated that the Company’s proposal to utilize its existing supply of Berubicin in its proposed Phase 2 clinical trial was reasonable if the Berubicin was reprocessed by batch GMP recrystallization and released under GMP specifications. In response to the FDA’s guidance, CNS contracted with Anthem and completed the GMP reprocessing of CNS’ existing supply of Berubicin.
“We are thankful to have such an experienced partner, Anthem, assist us in completing the critical reprocessing work of our existing Berubicin supply,” stated CEO of CNS, John M. Climaco. “The GMP reprocessing was a significant milestone in our continued efforts to prepare a new IND in accordance with the FDA guidance we received. We look forward to our upcoming potential Phase II trial evaluating the efficacy of Berubicin in subjects who have glioblastoma that has recurred or progressed following radiation therapy and temozolomide, as we believe in Berubicin’s potential to demonstrate in clinical trials that it can become the only effective anthracycline against brain cancer.” Read this and more news for CNSP at: https://financialnewsmedia.com/news-cnsp/
Other recent developments in the biotech industry include:
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) recently announced that it has received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for EluRyng™ (etonogestrel/ethinyl estradiol vaginal ring), the first generic version of NuvaRing®. Amneal has initiated commercialization activities for EluRyng, which is being manufactured internally and launching today.
“We are pleased to announce FDA approval of EluRyng, one of 15 new, complex products we expect to launch over the next 18 to 24 months,” said Chirag and Chintu Patel, Co-Chief Executive Officers. “This milestone underscores Amneal’s deep scientific and regulatory capabilities and our ability to overcome significant barriers to entry, including complex formulation development and specialized manufacturing requirements. In addition, EluRyng adds a differentiated, complex dosage form to our portfolio, and bringing this product to market reflects our commitment to improving affordable access to complex drug products. Looking ahead, we remain enthusiastic about the additional high-value opportunities in our pipeline that are designed to improve the lives of patients and drive meaningful growth and value-creation for our shareholders and other stakeholders in 2020 and beyond.”
Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) recently announced the successful completion of its clinical pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) for maralixibat for the treatment of pruritus associated with Alagille syndrome. In addition, the company had a chemistry, manufacturing and controls (CMC) meeting with the FDA. The purpose of the meetings was to discuss and confirm the clinical, non-clinical and CMC requirements for the company’s proposed NDA submission. The company also today announced that Rare Pediatric Disease Designation has been granted for maralixibat for Alagille syndrome, and thus may qualify for the receipt of a priority review voucher if the NDA is approved by the FDA. Maralixibat was recently granted Breakthrough Therapy Designation by the FDA for Alagille syndrome.
Axsome Therapeutics, Inc. (NASDAQ: AXSM) recently announced that AXS-05, a novel, oral, investigational NMDA receptor antagonist with multimodal activity, met the primary endpoint and rapidly and significantly improved symptoms of depression in the GEMINI Phase 3 trial in major depressive disorder (MDD). The GEMINI study was a randomized, double-blind, placebo-controlled, multi-center, U.S. trial, in which 327 adult patients with confirmed moderate to severe MDD were randomized to treatment with either AXS-05 (dextromethorphan/bupropion modulated delivery tablet) or placebo once daily for the first 3 days and twice daily thereafter for a total of 6 weeks.
AXS-05 met the primary endpoint by demonstrating a highly statistically significant reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score compared to placebo at Week 6, with mean reductions from baseline of 16.6 points for AXS-05 and 11.9 points for placebo (p=0.002). AXS-05 rapidly and durably improved depressive symptoms as compared to placebo with statistical significance on the MADRS total score demonstrated at Week 1, the earliest time point assessed, and at all time points thereafter. Rates of remission from depression (defined as MADRS ≤10) were statistically significantly greater for AXS-05 compared to placebo at Week 2 (p=0.013) and at every time point thereafter, being achieved by 39.5% of AXS-05 patients compared to 17.3% of placebo patients at Week 6 (p<0.001).
Heron Therapeutics, Inc. (NASDAQ: HRTX) recently announced that data supporting the novel mechanism of action for the investigational agent HTX-011 have been published online by the Regional Anesthesia & Pain Medicine (RAPM) journal, in an article entitled “Mechanism of action of HTX-011: a novel, extended-release, dual-acting local anesthetic formulation for postoperative pain.”
HTX-011 is a dual-acting, fixed-dose combination of the local anesthetic bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug meloxicam in a proprietary Biochronomer®polymer. It is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and opioid use through 72 hours compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control.
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