Vancouver, British Columbia – July 29, 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 a U.S. provisional patent application for a proprietary manufacturing process for the production of psilocybin and tryptamine analogues, baeocystin and aeruginascin.
“NOVA is developing a novel, proprietary synthetic drug pipeline, and our provisional U.S. patent application is an important step forward on our pathway to U.S. FDA drug approval and commercialization. We’re proud and excited about the technology NOVA has developed in conjunction with our API manufacturing partner and believe we have a great opportunity to demonstrate how our psilocybin-based therapeutics can help treat chronic neuroinflammatory disorders, including autism spectrum disorder (ASD),” says Will Rascan, NOVA’s CEO & President.
Psilocybin, baeocystin and aeruginascin are active compounds within mushrooms that at even at low doses can produce psychoactive effects. The levels of these compounds in dried mushrooms are only 0.2% – 1.0% of their dry weight and it is not practical to obtain meaningful pure amounts of these compounds from the flesh of mushrooms, at a reasonable cost, to conduct clinical trials in humans and to commercialize these products. The proprietary manufacturing process owned by NOVA will allow the company to totally control its future as it moves to test these compounds under U.S. FDA approved guidelines for clinical studies. NOVA has placed itself in a position to create a wholly owned Drug Master file (DMF) that contains confidential information about facilities, processes or articles used in the manufacturing, processing and packaging of human drugs. The information contained within the DMF may be used to support an Investigational New Drug (IND) application.
“The ability to produce these three psychedelically active tryptamine derivatives in greater than 98 per cent purity places NOVA in a unique position to create a novel entourage formulation to treat autism spectrum disorder (ASD), a complex multidimensional problem with many subsets,” stated Dr. Marvin S. Hausman MD, Chairman of NOVA’s Scientific Advisory Board. “NOVA intends to design and test its entourage formulation in the 3rd – 4th quarter 2021, in the same fragile X rat model that the company recently used to reveal significant behavioural improvement after treatment with its proprietary psilocybin drug.”
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).
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.
Vancouver, British Columbia – July 15, 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 the appointment of Dr. Stephen Glazer as Director, Chief Science Officer.
“We’re proud to welcome Dr. Glazer to our team, as he brings passion, dedication and 30 years of medical experience to our Board. He is a national leader in his field and his quest to help patients with chronic conditions with unmet medical needs will be an asset to our company and the research underway,” says Will Rascan, CEO & President.
Dr. Glazer began practicing medicine in Toronto, Ontario, Canada at North York Branson Hospital in 1994, and since then has been practicing as a board-certified specialist in Internal Medicine and Intensive Care Medicine in Ontario. He has become specialized in pre-operative risk assessment, has worked in the areas of cardiology and diabetes, and is recognized as a specialist in sleep medicine.
He is a specialist in bariatrics, the branch of medicine that deals with the study and treatment of people living with obesity. In 2010, Dr. Glazer became the Medical Director for Bariatrics at Humber River Hospital in Toronto. He sits on the board for the Ontario Bariatric Network, as well as on multiple committees. He is also the President of the Canadian Association of Bariatric Physicians and Surgeons.
“I’m looking forward to working closely with the team to help advance their clinical research program for neuroinflammatory disorders. Their novel approach, which includes using leading-edge AI technologies to accelerate the discovery of new therapeutics, is aligned with my scientific and medical interests, and I’m excited to add my expertise to the program,” says Dr. Stephen Glazer, NOVA’s Chief Science Officer.
Further, the Company has granted an aggregate of 3,100,000 incentive stock options (“the Options”) to members of its Board, management team and consultants of the Company. The Options are exercisable at a price $0.12 per share. 1,900,000 are valid for a period of 5 years and the balance are valid for a period of 2 years. The Options have been granted under and are governed by the terms of the Company’s incentive stock option plan.
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).
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.
Vancouver, British Columbia – June 23, 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 received Canadian approval for its North American autism clinical study.
The Company has obtained Institutional Review Board (IRB) approval in Canada of its protocol for the Observational Study, NM101: Establishing a Diagnostic and Therapeutic Index in Autism Spectrum Disorder (ASD) and Fragile X Syndrome (FXS) (NCT04869930). The study received IRB approval in the United States earlier this year.
“This approval expands the potential patient pool outside of the US into Canada and is a key step forward in enrollment of a diverse patient population,” stated Julia V. Perederiy, PhD, NOVA’s Lead Scientist and Principal Investigator on this study. “This approval further validates our high standards of ethical and clinical practice and will help accelerate achievement of NOVA’s goal to establish baseline clinical biomarkers in children and adults with the diagnosis of ASD and/or FXS. These biomarkers will be used to validate treatment responses in an upcoming psilocybin clinical study.”
IRBs are ethics committees designed to help regulatory agencies ensure that companies employ rigorous protocol standards and adhere to strict regulations surrounding the ethical treatment of human subjects. The study’s data collection and storage protocols are also compliant under the Health Insurance Portability and Accountability Act (HIPAA), which sets the standard for protection of sensitive patient data.
NOVA aims to recruit at least 300 participants across the U.S and Canada for its large-scale observational study to assess the gut microbiome, immune response, and serotonin activity, as all these systems are likely involved in producing the variety of gut and behavioural symptoms observed in ASD and FXS.
The Company will recruit 200+ participants with diagnosed ASD or FXS and 100+ neurotypical controls, including pre-symptomatic/undiagnosed children under age five. Participants will be asked to provide samples of cheek cells, urine, finger/toe-prick blood, and feces, which will be used to quantify serotonin levels and related cell signaling pathways, as well as evaluate commensal bacterial species and their function in the gut. Samples will be compared with those from age-matched neurotypical controls.
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).
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.
Vancouver, British Columbia – June 10, 2021 –Nova Mentis Life Science Corp. (CSE: NOVA) (FSE: HN3Q) (OTCQB: LIBFF) (“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 will be presenting at the H.C. Wainwright Psychedelics in Psychiatry and Beyond virtual conference on June 17, 2021.
“The conference is a great opportunity to discuss the potential for psychedelics to treat debilitating diseases that are not being met through traditional medicine, in the field of neuroinflammatory disorders such as Parkinson’s disease, multiple sclerosis, PTSD and especially autism spectrum disorder (ASD),” says Dr. Marvin S. Hausman, Chairman of NOVA’s Scientific Advisory Board.
In his address, Dr. Hausman will be discussing the approach NOVA will use for regulatory approval of its proprietary psilocybin and other tryptamine derivative formulations. Recent positive preclinical and safety data will also be revealed, as well as ongoing regulatory submission steps with the U.S. FDA and the European Medical Authority (EMA).
His presentation will be available on-demand starting at 7:00 a.m. EST on June 17, 2021. Click here to register for the conference and schedule a one-on-one meeting with Dr. Hausman.
The Company is currently conducting a large-scale observational study to assess the gut microbiome, immune/inflammatory response and serotonin activity, as all these systems are likely involved in producing the variety of behavioural symptoms observed in ASD and fragile X syndrome (FXS). The research will lead to the development of a set of biomarkers to help differentiate subsets of symptomatic, as well as pre-symptomatic, ASD and FXS patients – an approach that currently does not exist in clinical practice.
Further, the Company has entered into a debt settlement agreement pursuant to which the Company has agreed to issue 1,513,306 common shares (each, a “Share”), at a deemed price of $0.08 per Share, to settle indebtedness of $121,064.52 (the “Transaction”). All Shares issued pursuant to the Transaction are subject to a statutory four-month and one-day hold period.
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).
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.
Vancouver, British Columbia – May 6, 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 its North American autism clinical study has been listed on ClinicalTrials.gov (NCT04869930), a database of privately and publicly funded clinical studies conducted around the world.
The US-based Observational Study, NM101: Establishing a Diagnostic and Therapeutic Index in Autism Spectrum Disorder (ASD) and Fragile X Syndrome (FXS) is a large-scale effort to examine the dynamic roles of microbiota, serotonin signaling and the immune system in gut and brain development of ASD and FXS, particularly as these forces work together to manifest classic behavioral symptoms. AI-driven computational analysis of collected datasets will be used to establish a “Diagnostic and Therapeutic Index (ASD-DTI)” – an objective set of tools that can help differentiate subtypes of ASD and develop more accurate methods of diagnosis and response to drug treatment.
“We are developing this set of multidimensional biomarkers to help differentiate subsets of symptomatic, as well as pre-symptomatic, ASD and FXS patients – an approach that currently does not exist in clinical practice,” stated Julia V. Perederiy, PhD, NOVA’s Lead Scientist and Principal Investigator on the study. “Furthermore, we will use the index to subsegment participants in upcoming Phase 1 and Phase 2 clinical trials of NOVA’s proprietary psilocybin formulation – an essential step for study design and development of hard endpoints to corroborate clinical results.”
NOVA aims to recruit at least 300 participants across the U.S and Canada: 200+ with diagnosed ASD or FXS and 100+ neurotypical controls, including pre-symptomatic/undiagnosed children under age 5. Participants will be asked to provide samples of cheek cells, urine, finger/toe-prick blood and feces, which will be used to quantify serotonin levels and related cell signaling pathways, as well as evaluate commensal bacterial species and their function in the gut. Samples will be compared with those from age-matched neurotypical controls.
The study has been approved by an Institutional Review Board (IRB) in the United States, with planned expansion of the approval into Canada in the near future. IRBs are ethics committees designed to help regulatory agencies ensure that companies employ rigorous protocol standards and adhere to strict regulations surrounding the ethical treatment of human subjects. The study’s data collection and storage protocols are also compliant under the Health Insurance Portability and Accountability Act (HIPAA), which sets the standard for protection of sensitive patient data.
ClinicalTrials.gov is a web-based resource that provides patients, their family members, health care professionals, researchers and the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions. The web site is maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH).
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).
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.
Vancouver, British Columbia – April 20, 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 will be organizing a North American autism spectrum disorder (ASD) data bank to support the company’s development of psilocybin-based compounds in the diagnosis and treatment of ASD.
This newly launched serotonin research centre, in conjunction with a clinical Institutional Review Board (IRB) approved study, will quantify serotonin levels within various human samples, such as blood, urine and feces. Buccal cheek cells will also be obtained to measure genetic levels of several serotonin transporters.
“The quantitative information collected in the data bank will help to determine onset of ASD, progression of the disorder and response to various treatment modalities,” stated Marvin S. Hausman MD, Chairman of NOVA’s Scientific Advisory Board.
The company aims to recruit at least 300 participants across the U.S and Canada: 200+ with symptoms suggestive of ASD and 100+ neurotypical controls. Autism patient families will be encouraged to submit samples for analysis. The goal of the study is to identify ASD causative links and to advance personalized treatments through a better understanding of the many subtypes that make up the ‘autism spectrum,’ including fragile X syndrome. The data to be collected will form the basis for the upcoming dosing trial in the U.S., planned for later in 2021.
The study is compliant under the Health Insurance Portability and Accountability Act (HIPAA), which sets the standard for protection of sensitive patient data. Only patients, family, personal physicians, and NOVA scientists will be able to access the data. NOVA has received Institutional Review Board (IRB) approval in the United States for this observational study and is currently organizing Canadian IRB approval.
“Recent scientific data suggests that serotonin plays a dominating role in the development of the nervous system and serotonin levels should be studied in ASD children from birth until five years of age,” added Dr. Hausman. “It is for this reason that NOVA has undertaken the design and launch of a serotonin research centre in the United States. We want to give additional hope for families with autistic children that this unmet medical need is not being forgotten.”
One of the key pillars of NOVA’s research is to increase our understanding of the involvement of the enteric nervous system (ENS) in intestinal and neuroinflammatory conditions, including ASD, and to examine the role serotonin plays in organs outside the brain and in chronic disorders and diseases. Only 5-10 percent of serotonin is produced in the brain, 90-95 percent is produced in the rest of the body, especially in the small intestine. NOVA will be focused on studying the role of serotonin in various parts of the body and how we can use psilocybin to help correct serotonin problems.
Recent scientific statements and articles suggesting the importance of serotonin:
“Serotonin, responsible for mood in the brain and motility in the gut, can also act as a bacterial signaling molecule for pathogenic bacteria.”(1)
A recent University of Maryland School of Medicine study showed in a mouse model that the beneficial effect of psilocybin may work through other mechanisms of action besides a psychedelic experience.(2)
References:
(1) Leslie D. Knecht, Gregory O’Connor, Rahul Mittal, Xue Z. Liu, Pirouz Daftarian, Sapna K. Deo, and Sylvia Daunert. Serotonin Activates Bacterial Quorum Sensing and Enhances the Virulence of Pseudomonas aeruginosa in the Host. EBioMedicine. 2016 Jul; 9: 161–169. Published online 2016 May 28. doi: 10.1016/j.ebiom.2016.05.037.
(2) Natalie Hesselgrave, Timothy A. Troppoli, Andreas B. Wulff, Anthony B. Cole, and Scott M. Thompson. Harnessing psilocybin: antidepressant-like behavioral and synaptic actions of psilocybin are independent of 5-HT2R activation in mice. PNAS April 27, 2021 118 (17)https://doi.org/10.1073/pnas.2022489118.
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.
A subsidiary of Epitome Risk Solutions, FourthWall Testing is a private lab led by industry experts with more than 70 years of combined experience in drug research and development, as well as risk management services for the entertainment and sporting industries.
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.
Vancouver, British Columbia – March 31, 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 establishing a serotonin research centre in partnership with FourthWall Testing, in Winter Garden, Florida.
NOVA’s neuroinflammatory research program is based on identifying biomarkers that can be used to confirm the therapeutic efficacy of its proprietary psilocybin-based drug portfolio. NOVA intends to launch a longitudinal data bank to support large-scale studies of the microbiome, its relationship to serotonin activity and behavioral metrics as they relate to autism spectrum disorder (ASD). An initial focal point will be an observational study of individuals diagnosed with ASD and fragile X syndrome (FXS).
The Company recently announced that its proprietary psilocybin drug was able to modulate anxiety-like behaviour in a valproic acid (VPA) rat autism model. This experiment was performed in collaboration with the laboratory of Dr. Viviana Trezza, Roma Tre University, Rome, Italy.
“It is NOVA’s intent to identify specific microbes that may contribute to the development of ASD,” stated Marvin S. Hausman MD, Chairman of NOVA’s Scientific Advisory Board. “What is also most interesting is that 95 per cent of the body’s serotonin is produced by intestinal cells as well as bacteria in the human gut; only 5 per cent is produced in the brain. Serotonin is a key hormone that enables brain cells and other nervous system cells to communicate with each other. Our newly-launched serotonin research centre, as well as our research partnerships with Microbiome Insights and Thermo Fisher Scientific, provides us with the ability to discover potential biologic activities that lead to development of ASD and gives us a needed handle to assess treatment response of autistic children.”
The gut-brain axis is becoming a major discussion topic at neuroscience meetings and recent publications have shown that the trillions of bacteria in the gut could have a profound effect on the brain1,2. Studies in mice suggest that an infection in pregnancy can stimulate immune cells to produce molecules that travel to the fetus’s brain and provoke autism-like behaviour3.
There is communication between the enteric (bowel/gut) nervous system (ENS) and the brain. Dysfunction of the ENS is associated with swallowing problems, excess saliva, mild diarrhea, bowel obstructions and inflammatory bowel disease (IBD). ASD and Parkinson’s disease (PD) are two neurological disorders with signs of ENS involvement, as both are associated with gastrointestinal (gut) symptoms early in the disease course.
Increasing our understanding of ENS involvement in these intestinal and neuroinflammatory conditions could lead to early detection, suggest possible intervention and be a biologic marker for successful treatment response.
The NOVA research centre will be able to determine quantitative amounts of serotonin in fecal, blood and urine samples. Samples from the recently-completed VPA rat ASD study in the laboratory of Dr. Trezza are being shipped to the research centre. Fecal samples were collected from pregnant rats before and after VPA exposure as well as from the autistic offspring before and after psilocybin treatment. The research objective is to develop an analytic deep learning computer program that can analyze the data and identify specific developmental subsets of ASD that can be potentially treated with psilocybin therapy.
“Amassing a large volume of shotgun sequencing data, along with data on a neurotransmitter thought to be involved in the etiology of a poorly-understood disease like ASD will enable us to develop new methods for understanding the relationship between the microbiota community, serotonin levels and disease severity,” said Dr. Kyle H. Ambert, who is the Director of Data Science at Nike, Inc. and a member of NOVA’s Scientific Advisory Board.
The serotonin research centre also intends to analyze fecal, urine and blood samples from ASD and FXS individuals in the United States and Canada. An Institutional Review Board (IRB) approved clinical study has been launched by NOVA. A listing on ClinicalTrials.gov and formal start of recruitment in the U.S. will begin in the coming days.
NOVA’s research objective is to shed light on the mechanisms underlying the developmental disorder called ASD. Measuring serotonin levels alongside other biomarkers may also allow families of autistic individuals to assess disease progression and monitor response to therapeutic intervention.
Further, the Company announces that it terminated the agreement dated December 6, 2017 (the “Agreement”) whereby the Company acquired shares (based on certain milestones achieved) in Just Kush Enterprises Ltd (“Just Kush”), as announced on December 7, 2017.
The Company and Just Kush have agreed to terminate the Agreement as it contained several material provisions which are now impossible to perform due to a change in the respective statutory regime. Specifically, the Agreement contained milestones which must be met in order for substantial consideration to flow between certain of the parties and certain other obligations to cease, and these milestones were based upon grants of licensing under the Access to Cannabis for Medical Purposes Regime which was revoked and replaced by the Cannabis Act and Cannabis Regulations before said licenses were granted.
Pursuant to the termination agreement, purchase proceeds and advances paid by the Company pursuant to the terms of the Agreement will be returned or repaid to the Company at a later date pursuant to a loan agreement and the Company shall return all shares in the capital stock of Just Kush to the original shareholders. Just Kush has returned for cancellation 1,250,000 shares of the Company. The Company has also entered into a loan repayment agreement with Just Kush for certain funds advanced by the company under the build-out loan plan.
Neurogastroenterol Motil 2011 Mar;23(3):255-64. Reduced anxiety-like behavior and central neurochemical change in germ-free mice K M NeufeldN KangJ Bienenstock, J A Foster
How gut microbes could drive brain disorders. Nature Briefing. 08February2021
About FourthWall Testing
A subsidiary of Epitome Risk Solutions, FourthWall Testing is a private lab led by industry experts with more than 70 years of combined experience in drug research and development, as well as risk management services for the entertainment and sporting industries.
For more information, please visit: https://www.epitomerisk.com/fourthwall-testing/
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.
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.
Psilocybin formulation Modulates Anxiety-Like Behaviour in Rat Autism Model
Vancouver, British Columbia – March 29, 2021 –Nova Mentis Life Science Corp. (CSE: NOVA) (FSE: HN3Q) (OTCQB: NMLSF) (“NOVA” or the “Company”), a biotechnology company and global leader in developing diagnostics and psilocybin-based therapeutics for neuroinflammatory disorders, is pleased to announce, it has found early indications of a rescue effect with the use of psilocybin on anxiety-like behaviours related to autism spectrum disorder (ASD).
“The early results from this study are very encouraging and further validate our team’s efforts to establish the therapeutic potential of psilocybin for ASD patients,” said Will Rascan, President & CEO of NOVA.
Maternal prenatal exposure to valproic acid (VPA) has been shown to increase the incidence of autism in children. In rodents, VPA increases the prevalence of behavioural phenotypes associated with ASD.
To better understand the potential for psychedelics to ameliorate these autism-associated behaviours in the VPA rat model of autism, NOVA conducted a series of experiments to examine the effect of psilocybin on anxiety-like behaviour in the Elevated Plus Maze. This experiment was performed in cooperation with the laboratory of Dr. Viviana Trezza, Roma Tre University, Rome, Italy.
As expected, we were able to demonstrate that maternal prenatal VPA exposure induces autistic-like behaviours in the rat offspring, especially anxiety. Furthermore, we found early indications of a of psilocybin rescue effect on these anxiety-like behaviours.
An additional study, which is already in progress, is needed to confirm these findings. To further substantiate these initial results, NOVA has engaged well-known scientific research facilities to analyze the fecal microbiome and serum inflammatory biomarkers within the control and treated rat populations tested.
The overall objective of the study is to establish the efficacy of psilocybin in treating ASD, measure psychedelic drug response and establish therapeutic amounts of psilocybin to be used in an upcoming human trial.
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.
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.
Vancouver, British Columbia – March 10, 2021 –Nova Mentis Life Science Corp. (CSE: NOVA) (FSE: HN3Q) (OTCQB: NMLSF) (“NOVA” or the “Company”), a biotechnology company that is a global leader in the emerging field of serotonergic psychedelic medicine, is pleased to announce that it has been approved for trading on the OTCQB Venture Market effective today, March 10, 2021.
“The up-listing of our shares to the OTCQB is an important corporate milestone and is expected to enhance liquidity and increase awareness of the Company for our U.S. investors. It will allow us to access a broader audience, which is an important component of our Company’s development,” said William Rascan, NOVA’s President and CEO. “The increased exposure will be invaluable as the NOVA science team continues to further its clinical work to discover ways to treat autism spectrum disorder, including fragile X syndrome.”
The shares will trade under the new OTC trading symbol “NMLSF”. The Company’s shares will continue to trade on the Canadian Securities Exchange (CSE) under the symbol “NOVA” as well as the Frankfurt Stock Exchange (FSE) under the symbol “HN3Q”. In addition, the Company also wishes to advise that its shares are fully DTC eligible, which greatly simplifies its shares to be traded in the U.S.
The OTCQB Venture Market is designed for early-stage and developing companies in the U.S. and abroad.With more compliance, reporting and quality standards, the OTCQB provides investors improved transparency to enhance trading decisions.
Investors can find real-time quotes and market information for Nova Mentis on www.otcmarkets.com.
About Nova Mentis Life Science Corp.
Nova Mentis Life Science Corp. is a Canadian-based biotechnology company that is focused on the emerging field of serotonergic psychedelic medicine, such as psilocybin and its related tryptamine derivatives. The Company is a global leader in this field by integrating the latest state-of-the-art medical and scientific technology into its drug development program. The goal is to diagnose and treat debilitating chronic conditions that have unmet medical needs, such as autism spectrum disorder and fragile X syndrome.
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.
Vancouver, British Columbia – March 3, 2021 –Nova Mentis Life Science Corp. (CSE: NOVA) (FSE: HN3Q) (OTCQB: NMLSF) (“NOVA” or the “Company”), a leader in the development of psilocybin and other entheogens, is pleased to announce the launch of its US-based Observational Study NM-101: “Microbiotic Diversity in Autism Spectrum Disorder (ASD): Improving Diagnostics by Differentiating Subtypes.”
“NOVA’s mission is to discover more precise ways to diagnose and treat autism spectrum disorder (ASD), an unmet medical need,” stated Julia V. Perederiy, PhD, NOVA’s Lead Scientist and Principal Investigator on the study.
“This clinical investigation is an important first step in accurately defining subsets or cohorts of ASD patients that can best respond to specific psilocybin and entheogen therapy. Microbiome science and investigation continues to gain deeper insights into gut biology and its influence over brain activity and behaviour,” she continued.
This study will assess the gut microbiome across various subtypes of ASD (including fragile X syndrome) via genetic analysis of fecal samples, comparing bacterial profiles with those from age-matched neurotypical controls. This research is significant because shifts in gut bacteria contribute to the pathophysiology of GI disorders1, which are four times more common among children with ASD2 and are associated with worsening of behavioural symptoms, including anxiety, hypersensitivity and rigid-compulsive behaviours3.
NOVA’s observational clinical study aims to recruit at least 300 participants across the U.S.: 200+ with moderate/severe ASD and 100+ neurotypical controls. The large-scale design of this study, as well as inclusion of multidimensional datasets and proprietary machine learning systems, aims to resolve inconsistencies in prior clinical studies regarding the role of gut microbiota in ASD, particularly with regard to diagnostics and treatment – currently an unmet medical need.
“A study of this size will allow us to use machine learning to segment the patient population into groups based on microbiome characteristics, genomics and performance on behavioural tests,“ said Kyle H. Ambert, PhD, of NOVA’s Scientific Advisory Board. “Our findings here will help improve ASD diagnostic methods, allowing us to quantify disease severity using something besides behavioural methods alone.”
Study data will allow NOVA to develop an ASD Diagnostic Index and assist the company in the design and implementation of a planned Phase I Clinical Trial for NOVA’s lead psychedelic compound (PILZ 1013). Moreover, this study will be used in preliminary conversations with the U.S. FDA to define the optimal regulatory pathway and accelerate NOVA’s drug development program.
Vich Vila A, Imhann F, Collij V, et al. (December 2018). “Gut microbiota composition and functional changes in inflammatory bowel disease and irritable bowel syndrome.” Sci Transl Med. 10(472):eaap8914.
McElhanon BO, McCracken C, Karpen S, Sharp WG (May 2013). “Gastrointestinal symptoms in autism spectrum disorder: a meta-analysis.” Pediatrics. 133(5):872-83.
Mazurek MO, Vasa RA, Kalb LG, Kanne SM, et al. (January 2013). “Anxiety, sensory over-responsivity, and gastrointestinal problems in children with autism spectrum disorders.” J Abnorm Child Psychol. 41(1):165-76.
About Nova Mentis Life Science Corp.
Nova Mentis Life Science Corp. is a Canadian-based biotechnology company that is focused on the emerging field of serotonergic psychedelic medicine, such as psilocybin and its related tryptamine derivatives. The Company is a global leader in this field by integrating the latest state-of-the-art medical and scientific technology into its drug development program. The goal is to diagnose and treat debilitating chronic conditions that have unmet medical needs, such as autism spectrum disorder (ASD).
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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