PharmaTher Expands to Neuromuscular Diseases with Exclusive License Agreement for Ketamine in the Treatment of Lou Gehrig’s Disease
Newscope Capital Corporation (CSE: PHRM) (OTCQB: PHRRF), who through its wholly-owned subsidiary, PharmaTher Inc, is a specialty life sciences company focused on the research and development of psychedelic pharmaceuticals, is pleased to announce that PharmaTher has entered into an exclusive license agreement with The University of Kansas for the development and commercialization for the intellectual property of ketamine in the treatment amyotrophic lateral sclerosis (“ALS”), also known as Lou Gehrig’s disease.
The University of Kansas Medical Center inventors Dr. Richard J. Barohn, M.D., John A. Stanford, Ph.D., and Dr. Matthew Macaluso, D.O., have made the promising discovery that ketamine can be administered as an effective treatment for ALS. Their preclinical research has shown that the administration of ketamine preserves muscle function in advancing ALS and increases life expectancy when given in the early stages of muscle decline.
Currently, there is no known cure for ALS. ALS affects approximately 50,000 people in the U.S. and Europe, with over 5,000 new cases diagnosed annually. Peak sales for a new drug to treat ALS can achieve over USD $1 billion.
ALS is a progressive neuromuscular disease with a life expectancy of only 2 to 6 years after diagnosis. As ALS advances, upper and lower motor neurons die causing the brain to lose its ability to control muscle movement. ALS patients experience progressive loss of voluntary muscle action as an effect of the disease, resulting in the inability to speak, eat, move and, eventually, breathe.
Thus far, only three pharmaceuticals have been approved by the FDA for the treatment of ALS: riluzole, edaravone, and most recently, Nuedexta (dextromethorphan HBr and quinidine sulfate). These drugs are effective against disease mechanisms of ALS but fail to have measurable effects on attenuating disease progression or improve survival.
Therefore, there is an imperative need for new pharmacological therapies that can stop or slow the muscle decline associated with ALS progression and extend life expectancy of the ALS patient.
Ketamine has the potential to effectively increase life expectancy of those with ALS at any stage and slow the progressive loss of muscle associated with poor outcomes of the disease.
Ketamine works by blocking the action of the ionotropic glutamate receptor, the NMDA receptor. Unlike other inhibitors of NMDA receptor function, such as riluzole, ketamine dampens NMDA receptor-related glutamate excitotoxicity indirectly. Further, ketamine can lower D-serine concentrations intracellularly and also partially activates dopamine receptors. Collectively, these mechanisms of ketamine contribute in part to the drug’s neuroprotective effects which may extend to the motor neurons targeted in ALS.
PharmaTher will seek FDA approval for orphan drug designation of ketamine in the treatment of ALS and will advance towards an FDA investigational new drug application to conduct a Phase II clinical study this year.
These amendments are not just exciting for Numinus and our researchers, but also for our partners, clients and potentially academic collaborators in the psychedelics space. The amendments dramatically expand the work we can do with a far larger group of psychedelics, and open up market-leading and revenue-generating opportunities for Numinus in R&D, psychedelic formulations, research and analysis. Moreover, we can now develop and implement standardized psychedelics testing on top of our existing high throughput capabilities, and formulate and produce psychedelic compounds in finished packaged products for clinical trials, clinical use under exemption, and export.Sharan Sidhu, Science Officer and General Manager for Numinus Bioscience.
Under the terms of the Agreement, PharmaTher gained exclusive worldwide development and commercial rights to provisional patent no. 63/025,778 titled Ketamine to Extend Survival after Muscle Wasting in Amyotrophic Lateral Sclerosis. Consistent with industry standards, PharmaTher paid a one-time fee for entering into the Agreement, and all other future payments will be based on clinical trial and revenue milestones reached by PharmaTher.
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