PharmaTher Files FDA Pre-IND Meeting Request for Ketamine in Parkinson’s Disease
Ryan Allway
December 8th, 2020
Psychedelics
PharmaTher Inc., (“PharmaTher”), a wholly-owned subsidiary of Newscope Capital Corporation (CSE: PHRM) (OTC Pink: PHRRF) and a specialty life sciences company focused on the research and development of psychedelic pharmaceuticals, is pleased to announce that it has filed its pre-Investigational New Drug (“pre-IND”) meeting request and complete pre-IND briefing documents with the U.S. Food and Drug Administration (“FDA”) to support the clinical development of ketamine in Parkinson’s disease and to evaluate the proposed Phase 2 clinical study for ketamine in the treatment of levodopa-induced dyskinesia associated with Parkinson’s disease (“LID-PD”).
“We are pleased to have taken this important step in advancing our ketamine program for Parkinson’s disease via the FDA regulatory pathway, which is part of our overall strategy of progressing our novel ketamine prescription-based therapies to treat neurological disorders for FDA approval,” said Fabio Chianelli, CEO of PharmaTher. “We look forward to finalizing our Phase 2 clinical study for ketamine in Parkinson’s disease and leveraging the pre-IND meeting to unlock additional value in our exclusive FDA-based ketamine programs in depression and pain.”
PharmaTher is progressing its patent portfolio of novel ketamine therapies for Parkinson’s disease, depression and pain via the FDA regulatory pathway. The pre-IND meeting will provide valuable information to pave the way for the Company to conduct a Phase 2 clinical study in the U.S.
Results from preclinical data and case studies in Parkinson’s disease patients have shown that low-dose sub-anesthetic ketamine infusion indicates tolerability, safety and the potential of long-term therapeutic benefit to reduce levodopa-induced dyskinesia, improve on time, and reduce depression. 1-5
Ketamine is an FDA-approved drug with a known safety profile. PharmaTher entered into an exclusive license agreement with the University of Arizona to develop and commercialize ketamine in the treatment of Parkinson’s disease and has filed with the FDA to receive orphan drug designation for ketamine in the treatment of LID-PD.
The Company has assembled a prolific scientific and clinical team experienced in Parkinson’s disease, including Dr. Scott Sherman and Dr. Torsten Falk from the University of Arizona, Dr. Alberto Espay from the University of Cincinnati and Dr. Robert Hauser from the University of South Florida.
About Parkinson’s Disease
Parkinson’s Disease is a debilitating disorder that affects over 1 million people in the U.S. and more than 7 million people worldwide. There is currently no cure for Parkinson’s Disease, although some drug combinations are used to treat the disease symptoms. The global Parkinson’s Disease market is expected to grow from USD $5 billion in 2019 to USD $7.5 billion by the end of 2025 6 and it is estimated that the potential market opportunity for LID-PD to be over USD $3 billion in the U.S. alone.
About PharmaTher Inc.
PharmaTher Inc., a wholly-owned subsidiary of Newscope Capital Corporation (CSE: PHRM) (OTC Pink: PHRRF), is a specialty life sciences company focused on the research and development of psychedelic pharmaceuticals. PharmaTher repurposes psychedelic pharmaceuticals, such as FDA-approved ketamine and psilocybin, for FDA approval to treat neurological disorders.
Learn more at: PharmaTher.com and follow us on Twitter, LinkedIn and Facebook.
This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.
About Ryan Allway
Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.
Search CannabisFN
Press Coverage
Psychedelics Index
Top Videos
Rob is the co-founding President of Pelorus Equity Group and has more than 18 years of experience in the real estate finance industry. Since the formation of Pelorus in 2010, he has raised more than $175,000,000 in secured real estate transactions. Rob’s primary role at Pelorus Equity Group is the development of strategic alliances with […]
Tom Zuber is Zuber Lawler & Del Duca’s Managing Partner. He has a degree with highest honors in biomedical engineering and has advised some of the most iconic companies in the world on their patent and trademark portfolios. He is at the cutting edge of cannabis patent and trademark law. He holds degrees from Harvard University and Columbia Law […]
FinCanna is a royalty company that provides growth capital to rapidly emerging private companies operating in the licensed U.S cannabis industry.
From the rich soils of Southern Oregon, Kentucky and Colorado, Hemptown USA is growing some of the finest high cannabinoid hemp plants in the world.
Network Partners
About CFN Media Group
CFN Enterprises Inc. (OTCQB: CNFN) owns and operates CFN Media Group, the premier agency and financial media network reaching executives, entrepreneurs and consumers worldwide. Through its proprietary content creation, video library, and distribution via www.CannabisFN.com, CFN has built an extensive database of cannabis interest, assisting many of the world’s largest cannabis firms and CBD brands to build awareness and thrive. For more information, please visit www.cfnenterprisesinc.com.
Disclaimer: Matters discussed on this website contain forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. CFN Media Group, which owns CannabisFN, is not registered with any financial or securities regulatory authority and does not provide nor claims to provide investment advice or recommendations to readers of this release. CFN Media Group, which owns CannabisFN, may from time-to-time have a position in the securities mentioned herein and will increase or decrease such positions without notice. The Information contains forward-looking statements, i.e. statements or discussions that constitute predictions, expectations, beliefs, plans, estimates, or projections as indicated by such words as "expects", "will", "anticipates", and "estimates"; therefore, you should proceed with extreme caution in relying upon such statements and conduct a full investigation of the Information and the Profiled Issuer as well as any such forward-looking statements. Any forward looking statements we make in the Information are limited to the time period in which they are made, and we do not undertake to update forward looking statements that may change at any time; The Information is presented only as a brief "snapshot" of the Profiled Issuer and should only be used, at most, and if at all, as a starting point for you to conduct a thorough investigation of the Profiled Issuer and its securities and to consult your financial, legal or other adviser(s) and avail yourself of the filings and information that may be accessed at www.sec.gov, www.pinksheets.com, www.otcmarkets.com or other electronic sources, including: (a) reviewing SEC periodic reports (Forms 10-Q and 10-K), reports of material events (Form 8-K), insider reports (Forms 3, 4, 5 and Schedule 13D); (b) reviewing Information and Disclosure Statements and unaudited financial reports filed with the Pink Sheets or www.otcmarkets.com; (c) obtaining and reviewing publicly available information contained in commonlyknown search engines such as Google; and (d) consulting investment guides at www.sec.gov and www.finra.com. You should always be cognizant that the Profiled Issuers may not be current in their reporting obligations with the SEC and OTCMarkets and/or have negative signs at www.otcmarkets.com (See section below titled "Risks Related to the Profiled Issuers, which provides additional information pertaining thereto). For making specific investment decisions, readers should seek their own advice and that of their own professional advisers. CFN Media Group, which owns CannabisFN, may be compensated for its Services in the form of cash-based and/or equity-based compensation in the companies it writes about, or a combination of the two. For full disclosure, please visit: https://www.cannabisfn.com/legal-disclaimer/. A short time after we acquire the securities of the foregoing company, we may publish the (favorable) information about the issuer referenced above advising others, including you, to purchase; and while doing so, we may sell the securities we acquired. In addition, a third-party shareholder compensating us may sell his or her shares of the issuer while we are publishing favorable information about the issuer. Except for the historical information presented herein, matters discussed in this article contain forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. CFN Media Group, which owns CannabisFN, is not registered with any financial or securities regulatory authority, and does not provide nor claims to provide investment advice or recommendations to readers of this release. CFN Media Group, which owns CannabisFN, may from time to time have a position in the securities mentioned herein and will increase or decrease such positions without notice. For making specific investment decisions, readers should seek their own advice and that of their own professional advisers. CFN Media Group, which owns CannabisFN, may be compensated for its Services in the form of cash-based and/or equity- based compensation in the companies it writes about, or a combination of the two. For full disclosure please visit: https://www.cannabisfn.com/legal-disclaimer/.
Copyright © Accelerize Inc. · All Rights Reserved · Privacy Policy · Legal Disclaimer
