Dr. Hauser to advise Pharmather on the clinical development of ketamine for Parkinson’s Disease
TORONTO, Oct. 29, 2020 — Pharmather Inc., a wholly-owned subsidiary of Newscope Capital Corporation (“Pharmather” or the “Company”) (CSE: PHRM) and a specialty life sciences company focused on the research and development of psychedelic pharmaceuticals, is pleased to announce the appointment of Dr. Robert A. Hauser, MD, MBA, as a scientific and clinical advisor to the Company. Dr. Hauser currently serves as Professor of Neurology and Director of the University of South Florida Parkinson’s Disease and Movement Disorders Center.
“We would like to welcome Dr. Hauser as a scientific and clinical advisor to our Company and we look forward to his contributions as we continue to advance the clinical development of ketamine in the treatment of levodopa-induced dyskinesia associated with Parkinson’s Disease,” said Fabio Chianelli, CEO of Pharmather. “Dr. Hauser brings invaluable guidance and extensive clinical experience having served as Site Principal Investigator on over 100 clinical trials involving Parkinson’s Disease. With the addition of Dr. Hauser and our recent application for FDA orphan drug designation, we are building a solid foundation to advance ketamine for Parkinson’s Disease in a Phase 2 clinical study in an expeditious manner.”
“There is a significant unmet medical need for new treatments in Parkinson’s Disease,” said Dr. Hauser. “Pre-clinical studies and a patient case series suggest that ketamine has the potential to ameliorate levodopa-induced dyskinesia associated with Parkinson’s Disease. I look forward to working with the Pharmather team in their pursuit to advance this program to human clinical studies.”
Dr. Robert Hauser is Professor of Neurology at the University of South Florida College of Medicine, in Tampa, Florida. He serves as Director of the USF Parkinson’s Disease and Movement Disorders Center, a Parkinson Foundation Center of Excellence. Dr. Hauser earned a medical degree from Temple University School of Medicine, in Philadelphia, Pennsylvania, and completed neurology training at the Eastern Virginia Graduate School of Medicine, in Norfolk, Virginia. Dr. Hauser completed a fellowship in Movement Disorders at the University of South Florida and became Center Director in 1994. Dr. Hauser has authored or co-authored more than 300 peer-reviewed publications and is one of the world’s most cited Parkinson’s Disease investigators. He is Past Chairman of the Interventional Neurology Section of the American Academy of Neurology, has served on the executive committee of the Parkinson Study Group, and was a member of the steering committee for the NIH sponsored Neuroprotective Exploratory Trials in Parkinson’s Disease program (NET-PD). Dr. Hauser lectures frequently at scientific meetings and served as Chairman of the 2009 World Federation of Neurology International Congress on Parkinson’s Disease and Related Disorders. He has extensive expertise in clinical trial design and execution. Outcome measures that he developed have become the gold standard for use in clinical trials.
Dr. Hauser’s research focuses of the development of new therapies for Parkinson’s Disease and other Movement Disorders.
Promising Results with Ketamine in Parkinson’s Disease
Ketamine is an FDA-approved drug with a known safety profile. Prior clinical reports suggest that low-dose ketamine infusions are well tolerated and can improve pain and depression, both often comorbidities in Parkinson’s Disease patients.
Inventors Dr. Scott Sherman and Dr. Torsten Falk, both associate professors at the University of Arizona College of Medicine – Tucson, are working with Tech Launch Arizona to patent the results from preclinical data and five case studies in Parkinson’s Disease patients showing 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
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 20256 and it is estimated that the potential market opportunity for LID-PD to be over USD $3 billion in the U.S. alone.
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.
Levodopa is the gold standard for Parkinson’s Disease treatment but features significant drawbacks, including the major side effect of dyskinesia and a loss of effectiveness over time. Approximately 50% of patients with Parkinson’s Disease will develop Levodopa-induced dyskinesia 4-5 years after the initiation of levodopa therapy, and this number rises to 80% after 10-12 years of levodopa treatment. LID may interfere with motor function, cause or aggravate pain and is known to worsen the quality of life significantly.
Individuals with Parkinson’s Disease may experience a host of non-motor symptoms such as autonomic dysfunction, psychiatric (depression), cognitive and sensory symptoms (pain). Therefore, there is an urgent need for alternative treatments and has been identified by the regulatory authorities, patient advocacy groups such as Michael J. Fox Foundation, and key opinion leaders as a substantial unmet medical need.
About Pharmather Inc.
Pharmather Inc., a wholly-owned subsidiary of Newscope Capital Corporation (CSE: PHRM), is a specialty life sciences company focused on the research and development of psychedelic pharmaceuticals. Pharmather repurposes psychedelic pharmaceuticals, such as ketamine and psilocybin, for FDA approval to treat disorders of the brain and nervous system. Our team includes world-class strategic partners, advisors and a strong leadership team with a proven track record of success in drug development, business development and capital markets. Our goal is to advance the development of panaceAI™, our drug repurposing artificial intelligence platform, and our clinical product pipeline with ketamine and psilocybin in the treatment of Parkinson’s Disease, depression, pain, traumatic brain injury and stroke. Learn more at: pharmather.com and follow us on Facebook, Twitter and LinkedIn.
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Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.
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” 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 Company’s current belief or assumptions as to the outcome and timing of such future events. Forward-looking information in this press release includes information with respect to U.S. Food and Drug Administration (“FDA”) approval under an Orphan Drug Designation (“ODD”) and investigational new drug (“IND”) to conduct a Phase II clinical study, market opportunities in Parkinson’s Disease and levodopa-induced dyskinesia associated with Parkinson’s Disease (“LID-PD”), ketamine programs towards human clinical studies under the FDA regulatory pathway and product developments. 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 August 30, 2020 (“MD&A”), dated October 1, 2020, which is available on the Company’s profile at www.sedar.com.
1. UA Clinical Trial to Repurpose Ketamine for Parkinson’s Patients.
2. US20190060254A1— Compositions and methods for treating motor disorders.
3. Bartlett, et al, 2020. Preclinical evidence in support of repurposing sub-anesthetic ketamine as a treatment for L-DOPA-induced dyskinesia. Experimental Neurology. Volume 333.
4. Bartlett, M.J., Joseph, R.M., LePoidevin, L.M., Parent, K.L., Laude, N.D., Lazarus, L.B., Heien, M.L., Estevez, M., Sherman, S.J., Falk, T., 2016. Long-term effect of sub-anesthetic ketamine in reducing L-DOPA-induced dyskinesias in a preclinical model.
5. Sherman, S.J., Estevez, M., Magill, A.B., Falk, T., 2016. Case reports showing a long-term effect of subanesthetic ketamine infusion in reducing L-DOPA-induced dyskinesias. Case Rep. Neurol. 8, 53–58.
6. 360iResearch 2020.