Pharmather Announces Exclusive License Agreement with the University of Arizona for the Commercialization of Ketamine in the ...
October 15 2020 - 8:00AM
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 that the
Company has entered into an exclusive license agreement with the
University of Arizona for the development and commercialization of
ketamine in the treatment of Parkinson’s disease. Pharmather will
seek U.S. Food and Drug Administration (“FDA”) approval of an
investigational new drug (“IND”) application to conduct a Phase II
clinical study this year.
“We are very pleased to have an exclusive
license agreement in place with the University of Arizona to allow
Pharmather to advance the clinical program of ketamine in the
treatment of Parkinson’s disease, specifically targeting
levodopa-induced dyskinesia, a significant clinical unmet need,”
said Fabio Chianelli, Chief Executive Officer of Pharmather. “With
promising results in preclinical models and in Parkinson’s disease
patients, we aim to expeditiously advance the ketamine program in
Parkinson’s disease to reduce dyskinesia associated with levodopa
therapy with plans for expansion to treat depression and pain
associated with Parkinson’s disease and other motor disorders that
are prevalent in Multiple sclerosis, Alzheimer’s and Huntington’s
disease, ultimately creating a unique pharmaceutical-based ketamine
franchise.”
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. (References
1-5)
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 PD will
develop Levodopa-induced dyskinesia (“LID”) 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 advance our clinical product
pipeline with ketamine and psilocybin in Parkinson’s disease,
depression, traumatic brain injury and stroke. For more
information, visit www.pharmather.com.
For more information, please contact:Fabio
ChianelliChief Executive OfficerPharmather Inc.Tel:
1-888-846-3171Email: 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” 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 the Company will seek U.S. Food and
Drug Administration (“FDA”) approval under an investigational new
drug (“IND”) to conduct a Phase II clinical study this year, plans
for expansion to treat depression and pain associated with
Parkinson’s disease and other motor disorders that are prevalent in
Multiple sclerosis, Alzheimer’s and Huntington’s disease,
ultimately creating a unique pharmaceutical-based ketamine
franchise, 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.
References:
- UA Clinical Trial to Repurpose
Ketamine for Parkinson’s Patients.
- US20190060254A1— Compositions and
methods for treating motor disorders.
- 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.
- 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.
- 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.
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