Pilz Biosciences Advances Preclinical Research Investigating Psilocybin for Autism

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The innovative team at Nova Mentis Life Science Corp. (CSE: NOVA) announced their pending acquisition target, Pilz Bioscience Corp, has provided an insightful corporate update about their efforts to study psilocybin in the potential treatment of autism. 

Dr. Marvin S. Hausman, Chairman and Chief Scientific Officer at Pilz Biosciences, shared a promising report about the team’s research and development efforts. In a quote from their recent press release, Dr. Hausman said, “We are very pleased with the progress that we have made to date in advancing our scientific research mandate relating to our investigations into Autism Spectrum Disorder (ASD) and the potential for psilocybin and tryptamine-based compounds to be used in the treatment of this unmet medical need.” He continued: “To this end, we have accomplished a number of initial milestones which, we believe, will assist in setting the stage for our future scientific and commercial advancement.”

Beyond Serotonin: Exploring the Antioxidant Capacity of Magic Mushrooms

Unlike many traditional research efforts into psilocybin, the active ingredient in “magic mushrooms”, Dr. Hausman’s team is trying to identify potential mechanisms of action that go beyond serotonin. In their initial study aimed at testing Psilocybin and Psilocin for cellular bioavailability, the team found out that both compounds had antioxidant activity. Furthermore, the antioxidant activity exhibited by Psilocin was shown to be greater than that of Psilocybin. Finally, robust screening also demonstrated Psilocin showed significant antioxidant protection of red blood cells (RBC’s) by reducing intracellular oxidative stress. 

With the majority of attention in research being paid to the serotonin receptor activity of psychedelics, such as psilocybin and psilocin (the active metabolite of psilocybin), Dr. Hausman’s work is particularly unique.

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Pilz Biosciences Enters Strategic Master Services Agreement (MSA) 

The team at Pilz entered into a Master Services Agreement (MSA) with Comac Medical Ltd., an international clinical research company in Bulgaria. Comac is engaged in clinical trial monitoring, bioanalysis, GxP auditing, and biometrics. The strategic partnership will allow Pilz to design and perform complex pharmacokinetic and Phase 1 clinical studies, along with assisting in European regulatory filings for drug approval. As the movement to medicalize psychedelic drugs continues to gain momentum, key partnerships like these will form robust leadership teams to pioneer the way forward.

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Breaking Ground on Preclinical Studies Exploring Psychedelics for Autism 

The dynamic team at Pilz Biosciences is utilizing a unique rat model to evaluate the relationship between altered brain function in Autism Spectrum Disorder (ASD) and behavior. The scientists at Pilz will be able to directly test the efficacy of their new psychedelic pharmaceutical compounds in these animal models to launch their preclinical testing. Currently, the team is developing what they call the “Pilz ASD Correlate”, which is a unique proprietary diagnostic and therapeutic paradigm. The team intends to use it in preclinical and clinical models to test the therapeutic utility of the psilocybin and tryptamine derivatives they are currently developing. Through these robust research efforts, the team at Pilz is curating the next generation of personalized ASD therapy. 

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Pilz is Crafting Novel Psilocybin and Tryptamine Derivatives

In addition to their aforementioned MSA, the Pilz team has entered into a psilocybin and tryptamine derivative manufacturing agreement with a U.S. based pharmaceutical firm. They are collaborating closely with the manufacturing chemist in an effort to design a proprietary synthetic pathway that will facilitate patent filings. 

The Pilz team will have complete control of the Drug Master File (DMF) which will be utilized for regulatory submissions prior to embarking on human clinical trials. Currently, non-GMP psilocybin is being developed for preclinical testing in rat models, as discussed earlier. Considering these are schedule 1 drugs, it’s a significant regulatory achievement for Pilz to be preparing import and export licenses for these compounds.

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A Look Ahead for Dr. Hausman’s Team of Scientists

All these developments put Dr. Hausman’s team at Pilz, and their soon to be parent company, Nova Mentis, at a significant industry advantage. The successful evolution of preclinical and clinical research is fundamental to progress in the psychedelic renaissance. Currently, Dr. Hausman’s team is preparing to launch a truly novel study investigating the role of psilocybin for autism. Meanwhile, Nova’s pending acquisition of Pilz is sure to take these studies and the work of Dr. Hausman’s team to the next level.

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