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PharmaTher Expands to Neuromuscular Diseases with Exclusive License Agreement for Ketamine in the Treatment of Lou Gehrig’s Disease

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PharmaTher, a subsidiary of Newscope Capital Corporation (CSE: PHRM, OTCQB: PHRRF), has secured an exclusive license from The University of Kansas for the development of ketamine as a treatment for amyotrophic lateral sclerosis (ALS). Preclinical studies indicate that ketamine may enhance muscle function and prolong life expectancy in ALS patients. Currently, ALS lacks a cure, with FDA-approved treatments failing to significantly slow disease progression. The company plans to seek FDA orphan drug designation and conduct Phase II clinical trials this year.

Positive
  • Exclusive license agreement with The University of Kansas for ketamine treatment in ALS.
  • Preclinical research shows ketamine may preserve muscle function and increase life expectancy in ALS patients.
  • Potential peak sales for a new ALS drug could exceed $1 billion.
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  • None.

TORONTO, March 02, 2021 (GLOBE NEWSWIRE) -- Newscope Capital Corporation (CSE: PHRM) (OTCQB: PHRRF), who through its wholly-owned subsidiary, PharmaTher Inc. (“PharmaTher”), 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.        

“We are pleased to have added the Lou Gehrig’s disease program to our already impressive development pipeline that focuses on novel uses, formulations and delivery of ketamine in the treatment of neuropsychiatric, neurological and neuromuscular diseases,” said Fabio Chianelli, CEO of PharmaTher.

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.

About PharmaTher Inc.

PharmaTher Inc., a wholly-owned subsidiary of Newscope Capital Corporation (CSE: PHRM) (OTCQB: PHRRF), is a specialty life sciences company focused on the research and development of psychedelic pharmaceuticals for FDA approval to treat neuropsychiatric, neurological and neuromuscular diseases.

Learn more at:  PharmaTher.com and follow us on Twitter and LinkedIn.

For more information, please contact:        

Fabio Chianelli
Chief Executive Officer
PharmaTher Inc.
Tel: 1-888-846-3171
Email: info@pharmather.com
Website: www.pharmather.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

Cautionary Statement

This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated”, “potential”, “aim” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on the Newscope Capital Corporation’s (the “Company”) current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption “Risk Factors” in Company’s management’s discussion and analysis for the period of November 30, 2020 (“MD&A”), dated January 27, 2021, which is available on the Company’s profile at www.sedar.com.

This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.


FAQ

What does PharmaTher's license agreement with the University of Kansas involve?

PharmaTher has gained exclusive rights to develop and commercialize ketamine for ALS treatment.

What are the potential benefits of ketamine for ALS patients?

Ketamine may preserve muscle function and increase life expectancy when administered early in ALS.

What is the significance of ketamine's mechanism of action in treating ALS?

Ketamine blocks NMDA receptors, potentially providing neuroprotective effects that may slow muscle decline.

When does PharmaTher plan to conduct clinical trials for ketamine in ALS?

PharmaTher intends to conduct a Phase II clinical study and seek FDA orphan drug designation in 2021.

How many people are affected by ALS annually in the U.S. and Europe?

Approximately 50,000 people are affected by ALS, with over 5,000 new cases diagnosed annually.

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