Avicanna Inc. (“Avicanna” or the “Company”) (TSX: AVCN) (OTCQX: AVCNF) (FSE: 0NN), a commercial stage, international biopharmaceutical company focused on the commercialization of evidence-based, cannabinoid-based products, is pleased to announce that it has formalized its provisional patent application, entitled "Methods for Reducing or Eliminating Incidence of Seizures and Sudden Unexpected Death in Epilepsy", for the use of a novel cannabinoid formulation (the “Formulation Candidate”) after completion of in-vivo animal studies.

The formal application is filed with WIPO by claiming the priority date of US provisional application filed in September 2022 using the Patent Co-operation Treaty (PCT) system.

The research findings originated from Avicanna’s ongoing multi-level collaboration with leading epilepsy researcher Dr. Peter Carlen from the world-renowned Krembil Research Institute at the University Health Network (“UHN”). Preliminary electrophysiological studies on seizure-induced cortical slices taken from wildtype mouse determined that treatment with the Formulation Candidate produced significant anti-convulsant effects compared to treatment with cannabidiol (“CBD”) or tetrahydrocannabinol (“THC”) alone. These results, obtained in a well-established in vitro model, suggest that, in addition to anti-convulsant properties, the Formulation Candidate demonstrates strong potential to treat patients diagnosed with intractable forms of epilepsies and those at risk of seizure-induced Sudden Unexpected Death in Epilepsy (“SUDEP”). Studies on the mechanism of action of those cannabinoids in the Formulation Candidate confirmed that the cannabinoids acted as selective 5-HT1A receptor agonists similar to established 5-HT1A receptor agonists in seizure-like events.

The formulation candidate was tested further in the maximal electroshock (MES) in vivo animal models to confirm the anti-seizure effects in comparison to CBD alone. The research was carried out by Dr. Mac Burnham’s team at the University of Toronto. The Formulation Candidate further demonstrated strong anti-convulsant properties and therapeutic index value as compared to CBD alone. These results further substantiated the patent claims on the use of formulation candidate for reducing seizures and sudden unexpected death in epilepsy patients. Avicanna intends to advance this Formulation Candidate through its drug delivery platform and progress it through pre-clinical studies with a view towards potential future clinical studies.

"The exceptional collaborative research conducted by our R&D team with Dr. Carlen’s and Dr. Burnham’s teams and the resulting patent submission will be a major driver for long-term drug and clinical development plans. It is also a validation of the potential our scientific platform and drug pipeline have. Validating the anti-convulsant properties of our proprietary formulation in seizure disorders is important particularly since this combination drug has potential to reduce the likelihood of seizure-induced sudden death in epilepsy patients,” commented Dr. Frantz Le Devedec, Executive Vice President of Research and Product Development

About Avicanna Inc.

Avicanna is a commercial-stage international biopharmaceutical company focused on the advancement and commercialization of evidence-based cannabinoid-based products for the global medical and pharmaceutical market segments. Avicanna has an established scientific platform including R&D and clinical development that has led to the commercialization of more than thirty products across various market segments:

Medical Cannabis & Wellness Products: Marketed under the RHO Phyto™ brand these medical and wellness products are a line of pharmaceutical-grade cannabinoid products containing varying ratios of cannabidiol (“CBD”) and tetrahydrocannabinol (“THC”). The product portfolio contains a full formulary of products including oral, sublingual, topical, and transdermal deliveries that have controlled dosing, enhanced absorption and stability studies supported by pre-clinical data. The formulary is marketed with consumer, patient and medical-community education and training.

Pharmaceutical Pipeline: Leveraging Avicanna’s scientific platform, vertical integration, and real-world evidence, Avicanna has created a pipeline of patent-pending drug candidates that are indication-specific and in various stages of clinical development and commercialization. These cannabinoid-based drug candidates look to address unmet medical needs in the areas of dermatology, chronic pain, and various neurological disorders. Avicanna’s first pharmaceutical preparation (Trunerox™) is in the drug registration stage in South America.

Click to watch Avicanna’s Corporate Video 2022

SOURCE Avicanna Inc.

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Cautionary Note Regarding Forward-Looking Information and Statements

This news release contains “forward-looking information” within the meaning of applicable securities laws. Forward-looking information contained in this news release may be identified by the use of words such as, “may”, “would”, “could”, “will”, “likely”, “expect”, “anticipate”, “believe”, “intend”, “plan”, “forecast”, “project”, “estimate”, “outlook” and other similar expressions. Forward-looking information contained in this news release includes, without limitation, statements with respect to the Company’s future business operations, potential collaborations, the opinions or beliefs of management and future business goals. Although the Company believes that the expectations and assumptions on which such forward looking information is based are reasonable, undue reliance should not be placed on the forward-looking information because the Company can give no assurance that they will prove to be correct. Actual results and developments may differ materially from those contemplated by these statements. Forward-looking information is subject to a variety of risks and uncertainties that could cause actual events or results to differ materially from those projected in the forward-looking information. Such risks and uncertainties include, but are not limited to, current and future market conditions, including the market price of the common shares of the Company, and the risk factors set out in the Company’s annual information form dated March 31, 2022, filed with the Canadian securities regulators and available under the Company’s profile on SEDAR at www.sedar.com. The statements in this news release are made as of the date of this release. The Company disclaims any intent or obligation to update any forward-looking information, whether as a result of new information, future events or results or otherwise, other than as required by applicable securities laws.