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Company plans to submit clinical trial application in Canada
Vancouver, British Columbia–(Newsfile Corp. – September 15, 2022) – Nova Mentis Life Science Corp. (CSE: NOVA) (FSE: HN3Q) (OTCQB: NMLSF) (“NOVA” or the “Company”), a biotechnology company and world leader in psilocybin-based complementary therapies and diagnostics for neuro-inflammatory disorders is pleased to announce that it has completed production of psilocybin microdose capsules in collaboration with the Toronto Institute of Pharmaceutical Technology (TIPT®).
TIPT and NOVA recently completed manufacturing of a technical quantity of psilocybin microdose capsules which was used to confirm product specifications for the capsule. Production of the first stability batch followed and the capsules are currently undergoing release testing this week to generate the data required for a clinical trial application.
NOVA is currently preparing to submit a Clinical Trial Application to Health Canada for a Phase 2A study evaluating psilocybin microdose therapy for Fragile X Syndrome (FXS), the leading genetic cause of Autism Spectrum Disorders (ASD) . The recent from NOVA search results showed that a very low microdose formulation of the company’s psilocybin drug (NM-1001) significantly modulated behavioral and cognitive defects in a genetic model of FXS.
“A major success for NOVA in achieving this critical drug development achievement! Our team is incredibly dedicated and focused on achieving planned milestones as we strive to fulfill our mission of diagnosing and treating chronic diseases such as Autism Spectrum Disorders and Fragile X Syndrome,” said Jacqueline McConnell, Chief Operating Officer of NOVA.
The Company has formed a tactical partnership with KGK Science Inc. expand its portfolio of psilocybin-based drugs in Canada. KGK is a leading North American contract research organization based in London, Ontario that primarily provides high quality clinical research trials with a focus on the emerging nutraceutical, cannabis and psychedelic industries. The two companies plan to jointly submit Health Canada’s clinical trial application.
NOVA is the first biotechnology company to obtain orphan drug designation in the United States and European Union for the use of psilocybin in the treatment of FXS. Additionally, NOVA manufactured a large quantity of over 98% pure psilocybin for clinical studies and commercialization after the drug was approved.
About Nova Mentis Life Science Corp.
Nova Mentis Life Science Corp. is a Canadian-based biotechnology company and a global leader in the development of psilocybin-based diagnostics and therapies for neuroinflammatory disorders. Nova is the first biotechnology company to obtain orphan drug designation in the United States and European Union for the use of psilocybin in the treatment of fragile X syndrome (FXS).
Our goal is to diagnose and treat debilitating chronic conditions that have unmet medical needs, such as Autism Spectrum Disorders (ASD) and FXS.
For more information about the Company, please visit www.novamentis.ca or email [email protected].
The Toronto Institute of Pharmaceutical Technology (TIPT®) is North America’s premier pharmaceutical education, technology and research institute. We operate a fully GMP compliant and Health Canada licensed manufacturing and testing facility for solid dosage forms and liquid preparations.
Since our inception in 1992, we have successfully established corporate partnerships with leading pharmaceutical companies worldwide and delivered innovative product development solutions uniquely supported by pragmatic institutional experts.
For more information, please visit: www.tipt.com.
About KGK Science
Founded in 1997, KGK is a leading North American contract research organization based in London, Ontario, primarily providing high quality clinical research trials with a focus on the nutraceutical, cannabis and psychedelic industries. emerging. The company has successfully helped hundreds of companies with custom clinical trials and claims substantiation strategies to move products into global markets. KGK’s other existing service lines include expert regulatory and compliance support solutions, participant recruitment, research support services and advisory services. On a rough basis, the company has produced 150 publications to date, executed over 400 clinical trials in over 40 indications, amassed 25,000 participants in its database and collected 10 million data points.
For more information, please visit: www.kgkscience.com/.
On behalf of the board
Will Rascan, President and CEO
Nova Mentis Life Science Corp.
Toll Free: 1-833-542-5323
Neither the Canadian Securities Exchange nor its Market Regulator (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.
This press release contains statements that constitute “forward-looking statements”. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of Nova Mentis Life Science or developments in the industry to differ materially from the results, performance or achievements expectations expressed or implied by these forward-looking statements. – look at the statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words “expects”, “plans”, “anticipates”, “believes”, “intends”. , “estimates”, “projects”, “potential” and similar expressions, or that events or conditions “will”, “would”, “could”, “might” or “should” occur.
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