VANCOUVER, BC, Jan. 26, 2021 /CNW/ – Nova Mentis Life Science Corp. (CSE: NOVA) (FSE: HN3Q) (OTCPK: LIBFF) (“NOVA” or the “Company”) is pleased to announce that it has commenced the diagnostic and treatment phase of its ongoing preclinical model study of autism spectrum disorder (ASD). In this model, which is well accepted by neuroscientists, pregnant rats are exposed to valproic acid (VPA) and the resultant offspring have ASD behavioral symptoms.
NOVA had previously identified statistically significant changes in levels of inflammatory molecules, called cytokines, and in certain bacterial species within the intestinal microbiome of the ASD animals. In the current study, the Company will continue its measurement of the microbiome and cytokines in the animals with severe ASD behavioral symptoms and comparisons will be made to control animals. A treatment phase with its proprietary psilocybin compound is scheduled to begin in February 2021.
NOVA is also pleased to inform the medical community that the Company is actively designing human clinical observational study protocols to further confirm its Microbiome Diagnostic Index in ASD. Clinical protocols will be submitted for Institutional Review Board (IRB) approval in the U.S. and Europe as well as appropriate regulatory authorities.
“I am excited with the recent progress made by NOVA scientists, especially the announcement of our ASD psychedelic treatment study and the associated clinical application of our newly developed Microbiome Diagnostic Index,” stated Marvin S. Hausman MD, Chairman of NOVA’s Scientific Advisory Board. “We’re studying the microbiome-related correlates of VPA-induced Autism Spectrum Disorder (ASD) associated behaviors in a rodent model. In particular, we will be looking at temporal changes in the biome in newborn rodents prior to weaning, which has direct application to the human disorder.”
The utilization of the VPA ASD behavioral rat model was based on several facts. ASD is a developmental disorder whose main features are impairments in social interaction and verbal/non-verbal communication, together with stereotyped patterns of behavior. Despite scientific and clinical studies to date, the causes of ASD are still unknown. What is known is that human prenatal exposure to the drug valproate (VPA) is associated with increased risk of neurodevelopmental problems, cognitive deficits, and autism in children.
Dr. Trezza has shown that “a single prenatal injection of VPA in rodents results in behavioral impairments resembling the core signs of ASD, supporting the high face validity for prenatal VPA as an animal model of autism.” – Tartaglione, 2019(1). Several other research groups confirm these findings.
NOVA’s scientific premise is that the autism pathway induced by VPA may involve similar factors causing other chronic human diseases, including genetic, environmental chemicals, infections, neuroinflammation (oxidative stress), immune system dysfunction and alterations in the microbiome.
The Microbiome Diagnostic Index is being developed with the assistance of Dr. Kyle H. Ambert, a member of the NOVA Scientific Advisory Board. Dr. Ambert is currently Director of Data Science at Nike, Inc., and has extensive experience in data analytics, machine learning, artificial intelligence, and applied analytics. It is the goal of the Company to utilize machine learning to create a statistically objective biomarker program to measure psychedelic treatment response. As drug design and discovery becomes more personalized, machine learning methods are poised to become a central component of the pharmaceutical development workflow.
(1) Tartaglione, A.T., Schiavi, S., Calamandrei, G. and Trezza, V. 2019. Prenatal valproate in rodents as a tool to understand the neural underpinnings of social dysfunctions in autism spectrum disorder. Neuropharmacology 159,107477.
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 psychedelic medicine. The Company aims to become 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).
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