PALM BEACH, Florida, October 6, 2017 /PRNewswire/ --
Therapix Biosciences Ltd. (NASDAQ: TRPX), a specialty, clinical-stage pharmaceutical company focusing on the development of cannabinoid-based treatments, today announced it has entered into an exclusive agreement with Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, for the formulation, development and clinical manufacturing of THX-TS01, a first-in-class, proprietary investigational drug candidate for the treatment of the symptoms of Tourette Syndrome.
Pursuant to the agreement, Catalent will develop THX-TS01 in softgel form in support of Therapix's clinical development program and in accordance with current good manufacturing practice (cGMP). The formulation, development, analytical and cGMP manufacturing activities will be conducted at Catalent's primary softgel development and manufacturing facility in St. Petersburg, Florida. Read this entire release and more news for TRPX at: http://www.marketnewsupdates.com/news/trpx.html
Ascher Shmulewitz, M.D., Ph.D., Therapix's Chairman of the Board of Directors, said, "This is the first time that two cannabinoids, Tetrahydrocannabinol and Palmitoylethanolamide, which we believe work synergistically, are being combined in a proprietary single dose that may potentially provide a turnkey solution to addressing the symptoms of Tourette Syndrome. Our objective in developing THX-TS01 is to enable the commercialization of a more effective treatment for the symptoms of this devastating, unmet medical need. We believe that this agreement may bring us one step closer to this goal."
Dr. Shmulewitz continued, "This agreement with Catalent a world-class drug development, delivery and supply organization reflects our belief in the promise of THX-TS01 as we look forward to advanced-stage clinical trials and, if successful, commercialization. We could not be more pleased with Catalent as our new development and manufacturing partner." "The potential benefits of combining Tetrahydrocannabinol and Palmitoylethanolamide into a fully-optimized single dose, are manifold," said Adi Zuloff-Shani, Ph.D., Therapix's Chief Technology Officer. "This unique formulation could offer an enhanced biological effect and extended duration greater than that presented by administration of each component on its own." Professor Sarne's scientific publication detailing these findings, titled, "Reversal of age-related cognitive impairments in mice by an extremely low dose of tetrahydrocannabinol (THC)," was recently accepted for publication in Neurobiology of Aging, and will be presented at the International Association for Cannabinoid Medicines' (IACM) 9th Conference on Cannabinoids in Medicine being held September 29-30, 2017 in Cologne, Germany.
In other biotech industry news and market performance of note this week:
Canopy Growth Corporation (TSX: WEED.TO) (OTC: TWMJF) and Skinvisible Pharmaceuticals, Inc. (OTCQB: SKVI), a research and development company with a patented drug delivery system, recently announced they have signed a definitive license agreement for Skinvisible's patented topical formulations. Per the agreement, Canopy Growth is exclusively licensed to distribute Skinvisible's topical products in Canada, and shall have a first right of refusal for all other countries, excluding China and the United States.
Zynerba Pharmaceuticals, Inc. (NASDAQ: ZYNE), a clinical-stage specialty pharmaceutical company dedicated to developing and commercializing innovative pharmaceutically-produced transdermal cannabinoid treatments, late last week announced positive top line results from an open label exploratory Phase 2 FAB-C (Treatment of Fragile X Syndrome Anxiety and Behavioral Challenges with CBD) clinical trial evaluating ZYN002 cannabidiol (CBD) gel in pediatric and adolescent patients with Fragile X syndrome (FXS). The study successfully met its primary endpoint, achieving a 46% improvement (p<0.0001) in the total score of Anxiety, Depression, and Mood Scale (ADAMS) at week twelve compared to baseline. ZYN002 also achieved clinically meaningful improvements in all measures of the Aberrant Behavior Checklist for Fragile X (ABC-FXS), which address the key symptoms of FXS including social avoidance, temper tantrums, repetitive movements, and hyperactivity.
MannKind Corporation (NASDAQ: MNKD) this week announced that the U.S. Food & Drug Administration (FDA) has approved an update to the Afrezza prescribing information to include new clinical data that was presented at the American Diabetes Association's 76th Scientific Sessions in June 2016. Afrezza (insulin human) inhalation powder is approved by the FDA to improve glycemic control in adult patients with type 1 and type 2 diabetes mellitus. It is the only inhaled rapid-acting mealtime insulin available in the United States. Afrezza is dosed at the beginning of a meal and begins to appear in the blood in approximately one minute
Aptevo Therapeutics Inc. (NASDAQ: APVO), a biotechnology company focused on developing novel immuno-oncology and hematology therapeutics, this week announced that new information on the Company's proprietary next generation ADAPTIR™ protein therapeutic platform was presented at the 8th Annual World Bispecific Summit in Boston, MA, September 26-28, 2017. In a presentation entitled, "ADAPTIR™ Platform: Rapid Development of Novel Protein Therapeutics," Dr. Peter Pavlik, Principal Scientist at Aptevo, presented a comprehensive overview of Aptevo's next generation ADAPTIR platform, highlighting improvements that have led to the development of new ADAPTIR candidates with increased stability, superior manufacturability and antibody expression levels, and an extended half-life of up to 12.5 days in rodents.
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