Psyched Wellness Announces Key Findings from the 90-Day Oral Toxicity Study on AME-1
Toronto, Ontario--(Newsfile Corp. - February 15, 2022) - Psyched Wellness Ltd. (CSE: PSYC) (OTCQB: PSYCF) (FSE: 5U9) (the "Company" or "Psyched") a life sciences company focused on the production and distribution of artisanal functional and psychedelic mushrooms, is pleased to announce the key results from the 90-day oral toxicity preclinical study on its proprietary extract of the Amanita Muscaria mushroom (AME-1), with its contract research organization (CRO) partner.
The study was the third set of a group of thorough assessments on AME-1 conducted to determine the systemic toxicity potential of the Amanita Muscaria extract when administered once daily for 90 consecutive days, and summarizes the NOAEL (No Observed Adverse Event Level).
"This is the final step in the toxicological assessment of AME-1 that will form the foundation for the effective safe dose for human consumption and provides the necessary information for any future clinical studies," said Brian Tancowny, Scientific Advisor for Psyched Wellness. "With no adverse effect reported over the period, the study results reinforce our earlier findings about AME-1's safety and allows continued development of our products for human consumption."
A summary of the key findings in the report are as follows:
No adverse clinical signs of toxicity and neither mortality nor morbidity observed in both genders for vehicle and test item treated animals during the study period.
No treatment-related adverse effects on body weight and normal body weight gain were observed in all the treatment groups of both genders in comparison with the vehicle control groups during the study period.
No treatment-related adverse effects on feed consumption were observed in all the treatment groups of both genders in comparison with the vehicle control groups during the study period.
No treatment-related adverse effects on hematology parameters, coagulation, clinical chemistry, gross necropsy, and organ weights. All parameters studied were found to be normal during the duration of the study period.
No observed adverse event level occurred. This significant set of information obtained has resulted in the determination of the NOAEL and thus identified the safe effective dose for human consumption.
Jeffrey Stevens, CEO of the Company, said, "In addition to undertaking the 90-day toxicity study, Psyched has been focused on preparing the Self-Gras dossier which will position the Company to be able to sell products into the U.S. market and generate revenues in the first half of 2022. Our CRO partner was diligent in updating us on preliminary results throughout the study, advising that there were no findings of concern being recorded. We were very pleased that there were no adverse effects found in the toxicity study, and are grateful to our investors for their patience while the report was being finalized."
Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.
About Psyched Wellness Ltd.:
Psyched Wellness Ltd. is a Canadian-based health supplements company dedicated to the distribution of mushroom-derived products and associated consumer packaged goods. The Company’s objective is to create premium mushroom-derived products that have the potential to become a leading North American brand in the emerging functional food category. The Company is in the process of developing a line of Amanita muscaria-derived water-based extracts, teas and capsules designed to help with three health objectives: promote stress relief, relaxation and assist with restful sleeping.
Cautionary Statement Regarding Forward Looking Information
This press release contains “forward-looking information” within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on the Company’s current belief or assumptions as to the outcome and timing of such future events. The forward-looking information and forward- looking statements contained herein include, but are not limited to, statements regarding: the ability of the Company to develop Amanita Muscaria-derived products; the safety of Amanita Muscaria consumption and the safety and purity of any extracts thereof; and (ii) the uses and potential benefits of Amanita Muscaria.
Forward-looking information in this news release are based on certain assumptions and expected future events, namely: the Company’s ability to continue as a going concern; the Company’s ability to continue to develop its mushroom-derived products and associated consumer packaged goods; continued approval of the Company’s activities by the relevant governmental and/or regulatory authorities; and the continued growth of the Company.
These statements involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements, including but not limited to: the potential inability of the Company to continue as a going concern; risks associated with potential governmental and/or regulatory action with respect to the Company’s operations; competition within the psychedelics market; risks with respect to the safety of Amanita Muscaria consumption and the safety and purity of any extracts thereof; and the risk that there is no potential benefit of Amanita Muscaria consumption.
Readers are cautioned that the foregoing list is not exhaustive. Readers are further cautioned not to place undue reliance on forward-looking statements, as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated.
Forward-looking statements contained in this news release are expressly qualified by this cautionary statement and reflect the Company’s expectations as of the date hereof and are subject to change thereafter. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, estimates or opinions, future events or results or otherwise or to explain any material difference between subsequent actual events and such forward-looking information, except as required by applicable law.