XPhyto Provides Progress Update on Psychedelic Medicine Programs and Novel Compounds Milestone
Psychedelic Medicine -
Through its exclusive contract R&D collaboration with Applied Pharmaceutical Innovation ("Applied"), first announced on
Based on a systematic literature review, the Company identified mescaline (3,4,5-trimethoxyphenethylamine) as a promising candidate for the treatment of a broad range of mental disease states such as depression, anxiety, PTSD, and addiction, as well as cluster headaches. XPhyto and Applied developed a repeatable two-step reaction process with a yield greater than 60% and purity exceeding 99%, which is ideal for clinical use. Analytical methods were developed and validated and to date approximately 60 g of GMP grade mescaline has been manufactured for clinical trial evaluation.
With respect to mescaline drug delivery, XPhyto is focused on formulations designed to avoid common negative side-effects and provide precise and predictable dosage forms for clinical use. Mescaline is a naturally occurring psychedelic compound found in certain cacti, most notably peyote, San Pedro, and Peruvian Torch. These cacti are typically consumed via ingestion which has been associated with gastro-intestinal discomfort, nausea, and a lack of dosing predictability. The Company is pursuing a novel drug delivery system designed to prevent these common negative side-effects and complications; however, due to sensitivity related to intellectual property, further details cannot be disclosed at this time. The Company will announce further details in due course.
In addition to GMP mescaline synthesis and drug delivery, the Canadian operations are also focused on the design and synthesis of novel "2nd generation" psychedelic analogues. The Company has successfully developed and manufactured two promising novel compounds with properties designed to increase bioavailability. Intellectual property related information will be disclosed in due course.
XPhyto and Applied are developing a mescaline clinical trial strategy and are currently in the planning process for a robust Phase I clinical trial to commence in late 2022 to evaluate the safety and dosing parameters for mescaline-based treatment employing a proprietary drug delivery system. Details will be provided as decisions are finalized over the coming months.
"We see a lot of potential therapeutic value in psychedelic compounds for their ability to positively influence neural networks through growth and reorganization," said Prof. Dr. Löbenberg, XPhyto director and founder and director of the Drug Development and Innovation Centre,
Psychedelic Medicine -
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Forward Looking Statements
This news release includes statements containing forward-looking information within the meaning of applicable Canadian securities law ("forward-looking statements"). Forward-looking statements are frequently characterized by words such as "develop", "plan", "continue", "expect", "project", "intend", "believe", "anticipate", "estimate", "potential", "propose" and other similar words, or statements that certain events or conditions "may" or "will" occur, and in this release include the statement regarding the Company's goal of building a successful diagnostic, drug delivery, and medical cannabis company. Forward-looking statements are only predictions based on the opinions and estimates of management 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 projected in the forward-looking statements, including that the Company may not succeed in developing a commercial product; that the sale of products may not be a viable business; that the Company may be unable to scale its business; product liability risks; product regulatory risk; general economic conditions; adverse industry events; future legislative and regulatory developments; inability to access sufficient capital from internal and external sources, and/or inability to access sufficient capital on favourable terms; currency risks; competition; international risks; and other risks beyond the Company's control. The Company is under no obligation, and expressly disclaims any intention or obligation, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as expressly required by applicable law. Neither the CSE nor its Market Regulator (as that term is defined in the policies of the CSE) accepts responsibility for the adequacy or accuracy of this news release.
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