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Nova Mentis Applies to US FDA for Psilocybin Orphan Drug Designation Fragile X Syndrome Treatment

Nova Mentis Applies to US FDA for Psilocybin Orphan Drug Designation Fragile X Syndrome Treatment

Vancouver, British Columbia – September 14, 2021 – Nova Mentis Life Science Corp. (CSE: NOVA) (FSE: HN3Q) (OTCQB: NMLSF) (“NOVA” or the “Company”), a biotechnology company and global leader in first-in-class psilocybin-based therapeutics and complementary diagnostics for neuroinflammatory disorders, is pleased to announce it has filed an application with the U.S. Food and Drug Administration (FDA) to receive orphan drug designation for its proprietary psilocybin drug to  treat patients with fragile X syndrome (FXS), the most common inherited cause of autism spectrum disorder (ASD).

The U.S. Orphan Drug Act (ODA) grants special status to a drug for the treatment, diagnosis or prevention of a rare disease or condition. In the United States, a rare disease is defined as a condition that affects fewer than 200,000 people. Developmental delays affect ~13% of all American children ages 3-10 and FXS is the most common inherited cause of intellectual disability. The Centers for Disease Control and Prevention estimates FXS prevalence as 1 in 4,000 for males and 1 in 8,000 for females.

“NOVA is committed to accelerating the research and development of psilocybin-based therapeutics to help treat fragile X syndrome,” says Will Rascan, NOVA’s CEO & President. “With FDA orphan drug designation, our Company would qualify for benefits and incentives such as seven years of market exclusivity after drug approval, tax credits for clinical testing, eligibility for orphan drug grants and the waiver of the FDA New Drug Application filing fee of approximately $2.4 million.” He adds the Company filed for orphan drug designation with the European Medicines Agency (EMA) on August 12, 2021.

“New clinical treatments for FXS are needed and we believe serotonergic agonists like psilocybin represent  a promising option,” stated Dr. Marvin S. Hausman MD, Chairman of NOVA’s Scientific Advisory Board. “Psilocybin and other tryptamine derivatives are expected to modulate the molecular and behavioural underpinnings of the disorder, improve brain plasticity, improve cognition, reduce anxiety and behavioural rigidity. NOVA has successfully completed three preclinical studies confirming therapeutic efficacy, without apparent side effects, of Nova’s proprietary psilocybin drug. Moreover, an important catalyst driving the fragile X clinical program is the ability of our drug to modulate levels of neuroinflammatory molecules (cytokines) measured pre- and post-treatment.”

About Nova Mentis Life Science Corp.
Nova Mentis Life Science Corp. is a Canadian-based biotechnology company and global leader in developing diagnostics and psilocybin-based therapeutics for neuroinflammatory disorders. The goal is to diagnose and treat debilitating chronic conditions that have unmet medical needs, such as autism spectrum disorder (ASD) and Fragile X Syndrome (FXS).

For further information on the Company, please visit https://www.novamentis.ca or email info@novamentis.ca.

On Behalf of the Board
Will Rascan, President & CEO
Nova Mentis Life Science Corp.
Phone: 778-819-0244
Toll Free: 1-833-542-5323

Twitter: @novamentislsc
Instagram: @novamentislsc
Facebook: @novamentislsc

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 news release contains statements that constitute “forward-looking statements.” Such forward looking statements involve known and unknown risks, uncertainties and other factors that may cause Nova Mentis Life Science’s actual results, performance or achievements, or developments in the industry to differ materially from the anticipated results, performance or achievements expressed or implied by such forward-looking 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,” “may,” “could” or “should” occur.

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Nova Mentis to Present at the H.C. Wainwright Global Investment Conference

Nova Mentis to Present at the H.C. Wainwright Global Investment Conference

Vancouver, British Columbia – September 9, 2021 – Nova Mentis Life Science Corp. (CSE: NOVA) (FSE: HN3Q) (OTCQB: NMLSF) (“NOVA” or the “Company”), a biotechnology company and global leader in first-in-class psilocybin-based therapeutics and complementary diagnostics for chronic inflammatory disorders, is pleased to announce that it will present at the H.C. Wainwright 23rd Annual Global Investment Conference, from September 13-15, 2021.

Dr. Marvin S. Hausman, MD, Chairman of NOVA’s Scientific Advisory Board, will present recent positive preclinical therapeutic results in the treatment of autism spectrum disorder (ASD) with psilocybin. Discussion will also include NOVA’s planned steps toward initiating approved regulatory clinical studies in autism, as well as application of newly discovered psilocybin biomarker data that targets obesity and diabetes.

The presentation will be available on-demand starting at 7:00 a.m. EST on September 13, 2021, and continuing through September 15th. Click here to register for the conference and schedule a one-on-one meeting with Dr. Hausman.

About Nova Mentis Life Science Corp.
Nova Mentis Life Science Corp. is a Canadian-based biotechnology company and global leader in developing diagnostics and psilocybin-based therapeutics for neuroinflammatory disorders. The goal is to diagnose and treat debilitating chronic conditions that have unmet medical needs, such as autism spectrum disorder (ASD) and Fragile X Syndrome (FXS).

For further information on the Company, please visit https://www.novamentis.ca or email info@novamentis.ca.

On Behalf of the Board
Will Rascan, President & CEO
Nova Mentis Life Science Corp.

Phone: 778-819-0244
Toll Free: 1-833-542-5323
Twitter: @novamentislsc
Instagram: @novamentislsc
Facebook: @novamentislsc

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 news release contains statements that constitute “forward-looking statements.” Such forward looking statements involve known and unknown risks, uncertainties and other factors that may cause Nova Mentis Life Science’s actual results, performance or achievements, or developments in the industry to differ materially from the anticipated results, performance or achievements expressed or implied by such forward-looking 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,” “may,” “could” or “should” occur.

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An accidental finding

Nova Mentis Expands Psilocybin Research Program Targets Obesity and Diabetes

Nova Mentis (NOVA) was studying the effect of psilocybin on rats with autism symptoms when they discovered an unexpected finding…

Not only did the psilocybin improve anxiety and cognitive function in the rats, but it also seemed to impact the proteins that regulate inflammation, indicating that the formulation may be able to treat obesity and diabetes related to obesity (“diabesity”).

Another highly promising indicator is that psilocybin activates the 5-HT2C serotonin receptors, which play a role in body weight and food intake. In fact, one of the current FDA-approved obesity treatments called lorcaserin is also a serotonin receptor agonist, but it can have lots of unwanted side effects that psilocybin would likely avoid!

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Nova Mentis Expands Psilocybin Research Program Targets Obesity and Diabetes

Nova Mentis Expands Psilocybin Research Program Targets Obesity and Diabetes

Vancouver, British Columbia – September 7, 2021 – Nova Mentis Life Science Corp. (CSE: NOVA) (FSE: HN3Q) (OTCQB: NMLSF) (“NOVA” or the “Company”), a biotechnology company and global leader in first-in-class psilocybin-based therapeutics and complementary diagnostics for neuroinflammatory disorders, is pleased to announce that it is expanding its psilocybin research and development program to target obesity and diabetes.

NOVA recently finished three successful preclinical psilocybin treatments of rats with symptoms of autism spectrum disorder (ASD). Besides amelioration of anxiety and cognition issues in the ASD rats, as compared to controls, without significant psychedelic side effects, NOVA’s collaborative partners uncovered additional significant findings regarding inflammatory cytokines and chemokines, including their response to certain psilocybin dosing. These exciting unsuspected findings strongly suggest that NOVA’s proprietary psilocybin formulation has potential application to treatment of obesity, as well as diabetes related to obesity – “diabesity.”

Scientific studies have shown that there is a role for serotonin receptors such as 5-HT2C in the regulation of body weight and food intake. Mice without this receptor displayed an obese phenotype and epilepsy. 5HT2C receptors, regulate nerve excitability, are also implicated in ASD and react to psilocybin (1). Significantly, the US Food and Drug Administration (FDA) has approved the serotonin (5-hydroxytryptamine, 5-HT) 5-HT2C receptor agonist lorcaserin for the treatment of obesity which represents a new therapeutic drug class available to the clinic. Targeting serotonin receptors with agonists such as psilocybin opens the door for a new class of therapy for diabesity.

“I am particularly excited that the ASD rat model that NOVA has tested in the laboratory of Dr. Viviana Trezza in Rome, Italy, has revealed inflammatory receptor technology that can be utilized in studying the potential role of psilocybin in control of obesity and diabetes,” stated Dr. Marvin S. Hausman MD, Chairman of NOVA’s Scientific Advisory Board. “NOVA’s technology has shown that its proprietary compound, psilocybin, can influence levels of inflammatory chemokines/cytokines that transmit physiologic messages with the potential to influence responses within the serotonergic system. A diagnostic mRNA genetic inflammatory panel is being developed with the assistance of Thermo Fisher Scientific and this panel will be studied in ASD individuals in an upcoming IRB approved observational clinical study.”

There is a global presence of diabesity in almost epidemic proportions (2,3). Current options include bariatric surgery and medical management including pharmacologic agents, but there remains no consensus approach as to how to control diabesity. Long term management appears to require varying combinations of anti-diabetic and anti-obesity medications. Current majority opinions of companies in the psychedelic field are to focus on use of a psychedelic compound as part of psychotherapy, so-called drug-enhanced psychotherapy. NOVA’s recent finding of psilocybin’s effect on specific inflammatory cytokine clinical biomarkers opens the door to a potentially novel approach to control diabesity.

“These exciting findings may be extremely promising in the treatment of diabesity. Because inflammation plays an important role within the adipocyte and other organs, attenuating the inflammatory response, leading to decreased dysfunction, may significantly impact the short and long-term complications seen in those living with obesity and diabetes,” stated Dr. Stephen A. Glazer MD, NOVA’s Chief Science Officer.

References:

  1. Fletcher PJ et al. Characterizing the effects of 5-HT2C receptor ligands on motor activity and feeding behaviour in 5-HT2C receptor knockout mice. Neuropharm. 2009; 57: 259-267.
  2. World Health Organization. 2015 Obesity and overweight. Geneva: World Health Organization. http://www.who.int/mediacentre/factsheets/fs311/en/.
  3. Ogden CL et al. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014; 311:806–14.

About Nova Mentis Life Science Corp.

Nova Mentis Life Science Corp. is a Canadian-based biotechnology company and global leader in developing diagnostics and psilocybin-based therapeutics for neuroinflammatory disorders. The goal is to diagnose and treat debilitating chronic conditions that have unmet medical needs, such as autism spectrum disorder (ASD) and Fragile X Syndrome (FXS).

For further information on the Company, please visit https://www.novamentis.ca or email info@novamentis.ca.

 

On Behalf of the Board

Will Rascan, President & CEO
Nova Mentis Life Science Corp.

Phone: 778-819-0244
Toll Free: 1-833-542-5323

Twitter: @novamentislsc

Instagram: @novamentislsc

Facebook: @novamentislsc

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 news release contains statements that constitute “forward-looking statements.” Such forward looking statements involve known and unknown risks, uncertainties and other factors that may cause Nova Mentis Life Science’s actual results, performance or achievements, or developments in the industry to differ materially from the anticipated results, performance or achievements expressed or implied by such forward-looking 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,” “may,” “could” or “should” occur.

 

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Taking the trip out of psilocybin

Nova Mentis Files Fragile X Orphan Drug Designation with European Medicines Agency

Fragile x syndrome (FXS) is the leading genetic cause of autism spectrum disorder (ASD) symptoms, yet there is currently no approved prevention or treatment options. Nova Mentis (NOVA) is working to fill this gap with a non-psychedelic psilocybin-based drug.

The company announced that its proprietary psilocybin drug, NM1010, was able to improve cognition without a creating psychedelic effect in a preclinical model of FXS. In tests on animals, the drug showed improvements in inflammatory biomarkers that may be linked to the ASD disease process.

The company has filed for orphan drug designation with the European Medicines Agency (EMA), a status that gives companies exclusive rights and tax credits to incentive the development of treatments for diseases affecting ≤ 5 in 10,000 people.

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Nova Mentis Files Fragile X Orphan Drug Designation with European Medicines Agency

August 12, 2021 6:00 am Published by 

Novamentis

 

Vancouver, British Columbia – August 12, 2021 – Nova Mentis Life Science Corp. (CSE: NOVA) (FSE: HN3Q) (OTCQB: NMLSF) (“NOVA” or the “Company”), a biotechnology company and global leader in first-in-class psilocybin-based therapeutics and complementary diagnostics for neuroinflammatory disorders, is pleased to announce it has filed for orphan drug designation with the European Medicines Agency (EMA) for its propriety psilocybin drug to help treat patients with fragile X syndrome (FXS), the leading genetic cause of symptoms related to autism spectrum disorder (ASD).

“NOVA is continuing to advance our research and drug development program to explore the clinical potential of psilocybin for chronic neuroinflammatory conditions with unmet medical needs,” says Will Rascan, NOVA’s CEO & President. “Orphan drug designation would give our Company a wide range of incentives that include assistance with trial protocols, reduced regulatory fees and 10 years of market exclusivity after drug approval.”

NOVA’s R&D plan towards successful regulatory approval and commercial launch of psilocybin in ASD and FXS follows standard procedures in drug development, used by established pharmaceutical companies. Our proprietary manufacturing process will deliver >98% cGMP psilocybin – repetitively and consistently. The Company is setting up a data bank of biologic markers associated with ASD and FXS, which will supplement behavioural results, improve identification of specific disease subsets, and aid development of patient-specific treatments. In the immediate future, NOVA plans to submit regulatory documents to the FDA and EMA that support psilocybin’s potential therapeutic efficacy. These will include statistical analyses of baseline observational data and biomarkers of disease outcomes, including the neurotransmitter serotonin and other physiologically active biomarkers involved in the development of ASD and FXS. Finally, NOVA will conduct clinical trials to evaluate how ASD and FXS patients may benefit from psilocybin therapy. These trials will be designed according to ethical principles and rooted in insights gained from our non-interventional studies and novel biomarker panels.

“NOVA’s lead drug candidate psilocybin (NM1010), in a  preclinical model of  FXS, has revealed positive improvement in cognition without apparent psychedelic side effects,” stated Dr. Marvin S. Hausman MD, Chairman of NOVA’s Scientific Advisory Board. “I am also excited to report that psilocybin-treated animals showed changes in inflammatory biomarkers that are potentially involved in the ASD disease process.”

FXS is a genetic neurological disorder in which the reduction/absence of the FMR1 protein (FMRP) leads to dysfunction in neural signaling and behavioral abnormalities. The total number of patients in the European Union (EU) was estimated to be ~88,000 for an overall prevalence of 2 in 10,000, which is below the ceiling for orphan designation of 5 in 10,000.

There are currently no approved prevention or treatment methods, though psychiatric approaches to autism spectrum disorder have been used in FXS with some success. Currently available therapies for FXS – including pharmaceutical and behavioural interventions – fail to address the emotional aspects of the disorder, offering a patchwork of solutions that have limited efficacy and high toxicity.

Psilocybin is proposed as a novel, first-in-class treatment for FXS. Beyond the promising cognitive benefits, psilocybin also has peripheral effects, including the capacity for curbing inflammation and modulating microbiota. Given the high prevalence of GI disorders in FXS, psilocybin and other tryptamine derivatives may offer additional benefit in the gut. Psilocybin is expected to modulate molecular and behavioural underpinnings of FXS, including improvements in brain plasticity and reduction in anxiety and behavioural rigidity – a significant step above currently available methodologies.

The EMA is a decentralised agency of the EU responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU. Orphan designation is a status assigned to a medicine intended for use against a rare condition. The prevalence of the condition in the EU must not be more than 5 in 10,000 and the medicine must fulfil certain criteria.

About Nova Mentis Life Science Corp.
Nova Mentis Life Science Corp. is a Canadian-based biotechnology company and global leader in developing diagnostics and psilocybin-based therapeutics for neuroinflammatory disorders. The goal is to diagnose and treat debilitating chronic conditions that have unmet medical needs, such as autism spectrum disorder (ASD) and Fragile X Syndrome (FXS).

For further information on the Company, please visit https://www.novamentis.ca or email info@novamentis.ca.

On Behalf of the Board
Will Rascan, President & CEO

Nova Mentis Life Science Corp.
Phone: 778-819-0244
Toll Free: 1-833-542-5323
Twitter: @novamentislsc
Instagram: @novamentislsc
Facebook: @novamentislsc

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 news release contains statements that constitute “forward-looking statements.” Such forward looking statements involve known and unknown risks, uncertainties and other factors that may cause Nova Mentis Life Science’s actual results, performance or achievements, or developments in the industry to differ materially from the anticipated results, performance or achievements expressed or implied by such forward-looking 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,” “may,” “could” or “should” occur.

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Glow Acquires Strategic Equity Investment in Nova Mentis

August 11, 2021 9:00 am Published by 

Novamentis

 

TORONTO, Ontario -August 10, 2021 – Glow LifeTech Corp. (CSE: GLOW) (FSE: 9DO) (“Glow” or the “Company”), a biotech company focused on producing next-generation, science-backed natural ingredients, is pleased to announce a strategic investment into Nova Mentis1 (“Nova”).

The Company purchased 854,000 shares in Nova at an average cost of $0.12 CAD.

Nova Mentis Life Science Corp. is a Canadian-based biotechnology company and global leader in developing diagnostics and psilocybin-based therapeutics for neuroinflammatory disorders. Their goal is to diagnose and treat debilitating chronic conditions that have unmet medical needs, such as autism spectrum disorder (ASD) and Fragile X Syndrome (FXS).

RECENT NEWS: Glow announced that it secured a Canadian processing facility to begin build-out to produce next-generation cannabis ingredients:2 https://bit.ly/3xBYqYT

SUBSCRIBE: For more information on Glow or to subscribe to the Company’s mail list visit: https://www.glowlifetech.com/news

 

About Glow LifeTech Corp.

Glow LifeTech is a Canadian-based biotechnology company focused on producing nutraceutical and cannabinoid-based products with dramatically enhanced bioavailability, absorption and effectiveness. Glow has rights to the groundbreaking, plant-based MyCell Technology® delivery system, which transforms poorly absorbed natural compounds into enhanced water-compatible concentrates that unlock the full healing potential of the valuable compounds.

Website: www.glowlifetech.com

 

Contact:

James Van Staveren Glow LifeTech Corp.

Office. 647-872-9982 ext. 2

TF. 1-844-247-6633 ext. 2

ir@glowlifetech.com

Forward-looking Information Cautionary Statement

Except for statements of historic fact, this news release contains certain “forward-looking information” within the meaning of applicable securities law. Forward-looking information is frequently characterized by words such as “plan”, “expect”, “project”, “intend”, “believe”, “anticipate”, “estimate” and other similar words, or statements that certain events or conditions “may” or “will” occur. Forward-looking statements are based on the opinions and estimates at the date the statements are made, and are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those anticipated in the forward-looking statements including, but not limited to delays or uncertainties with regulatory approvals, including that of the CSE. There are uncertainties inherent in forward-looking information, including factors beyond the Company’s control. There are no assurances that the commercialization plans for the technology described in this news release will come into effect on the terms or time frame described herein. The Company undertakes no obligation to update forward-looking information if circumstances or management’s estimates or opinions should change except as required by law. The reader is cautioned not to place undue reliance on forward-looking statements. Additional information identifying risks and uncertainties that could affect financial results is contained in the Company’s filings with Canadian securities regulators, which filings are available at www.sedar.com

1 https://www.novamentis.ca/

2 https://www.glowlifetech.com/news-blog/glow-lifetech-secures-canadian-processing-facility-begins-build-out-to-produce-generation-cannabis-ingredients