PreveCeutical & Endosane Announces Innovative Preclinical Approaches to Assess Brain Availability of CBD And Pharmacologically Relevant Doses Following Intranasal CBD Application

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Sep 18, 2023, 07:00 ET

VANCOUVER, BC, Sept. 18, 2023 /PRNewswire/ - PreveCeutical Medical Inc. (the "Company" or "PreveCeutical") (CSE: PREV) (OTCQB: PRVCF) (FSE: 18H), is proud to announce that Endosane Pharmaceuticals GmbH will proceed with its research initiative focused on preclinical studies to evaluate the brain delivery characteristics of sol-gel technology and whether pharmacologically relevant concentrations of CBD can be achieved with this technology. The company's commitment to advancing medical research is demonstrated through its comprehensive research proposal for a first preclinical study in rats.

Research Objectives:

The primary objectives of this study include:

Objective 1: Investigating the potential of sol-gel technology for rapid delivery of CBD to the brain. This includes assessing the amounts achieved, regional distribution, and time course of CBD uptake in the brain (Experiments 1 and 2).

Objective 2: Demonstrating the pharmacological relevance of brain CBD concentrations following intranasal application (Experiment 3).

Study Design:

The research will be conducted through a series of well-structured experiments:

Experiment 1: Rats will be administered up to three doses of CBD in sol-gel form via nasal spray. Evaluation will be carried out at six different time points. Brain regions such as the olfactory bulb, prefrontal cortex, parietal cortex, pons, and cerebellum will be assessed, and concentrations of CBD and its metabolites will be quantified using a validated LC-MS/MS assay.

Experiment 2: A separate group of rats will receive intranasal CBD administration. Cerebrospinal fluid (CSF) and cardiac blood samples will be collected at specific time points based on the findings from Experiment 1. CBD and metabolite concentrations will be measured using validated LC-MS/MS assays.

Experiment 3: Building upon the outcomes of Experiment 1, the study will assess intranasal CBD doses that yield significant brain exposure in rat models of anxiety and chronic pain. These are two conditions in which CBD has already demonstrated preclinical efficacy.

Collaborative Efforts:

Endosane is collaborating closely with the Brain and Mind Centre of the University of Sydney. A significant breakthrough in this partnership has been the identification of anandamide as a potential blood surrogate marker for CBD's brain activity. The research team has also examined the temporal changes in serum.

PreveCeutical and Endosane dedication to research in the field of CBD delivery and pharmacology underscores its commitment to advancing medical knowledge and improving patient outcomes. The company remains focused on scientific innovation, working diligently to pave the way for novel treatments and therapies.

About Endosane

Endosane Pharmaceuticals GmbH, a joint venture between an international team of scientists and the Berlin-based health and life science company Sanity Group, develops finished medicinal products for the treatment of neuropsychiatric and psychiatric disorders. To this end, Endosane Pharmaceuticals is systematically researching the endocannabinoid system for its potential to modulate neurophysiological balance. The current drug portfolio contains compounds for the treatment of various indications, including schizophrenia, social anxiety disorder and post-traumatic stress disorder. The international team is led by the renowned German neurologist and psychiatrist Prof. Dr. F. Markus Leweke (University of Sydney), long-time head of the Center of Excellence for Psychiatry and Psychotherapy Research at the Central Institute of Mental Health Mannheim at the Ruprecht-Karls-University Heidelberg. The company, founded in 2020, is based in Berlin. More information at www.endosane.com.

About the Sanity Group

Sanity Group has set itself the goal of improving the quality of life of people through the sensible use of cannabinoids and the use of the endocannabinoid system. In addition to pharmaceuticals, it also focuses on well-being and cosmetic products based on cannabinoids. In parallel, Sanity Group is working and researching new medical products, innovative dosage forms, as well as technological products and services to further develop the infrastructure. Sanity Group was founded in 2018 by Finn Age Hänsel and Fabian Friede and now employs a team of over 100 people at its headquarters in Berlin-Mitte and its research site near Frankfurt am Main. Sanity Group brands include Vayamed (pharmaceuticals), VAAY (CBD products) and This Place (functional cosmetics). More information at www.sanitygroup.com.

About PreveCeutical

PreveCeutical is a health sciences company that develops innovative options for preventive and curative therapies utilizing organic and nature identical products. The Company aims to be a leader in the preventive health sciences sector.

With the completion of three of its research programs, the Company is actively working on the development, clinical trials, and commercialization of its products; and has filed a number of provisional patent applications to protect the intellectual property from its research programs.

For more information about PreveCeutical, please visit our website, www.PreveCeutical.com or follow us on Twitter and Facebook.

On behalf of the Board of Directors of PreveCeutical

Stephen Van Deventer, Chairman and Chief Executive Officer

Forward-Looking Statements:

This news release contains forward-looking statements and forward-looking information (collectively, "forward-looking statements") within the meaning of applicable Canadian and U.S. securities legislation, including the United States Private Securities Litigation Reform Act of 1995. All statements in this news release that are not purely historical are forward-looking statements and include any statements regarding beliefs, plans, expectations and orientations regarding the future, including, without limitation, statements regarding the timing, completion and the final terms and conditions of a license agreement entered into between the Company and Endosane, the Company's role in the development and testing of products utilizing the sol-gel technology, the continued research interests of PreveCeutical, PreveCeutical's anticipated business plans, and its prospects of success in executing its proposed plans. Often, but not always, forward-looking statements can be identified by words such as "will", "pro forma", "plans", "expects", "may", "should", "budget", "schedules", "estimates", "forecasts", "intends", "anticipates", "believes", "potential", "proposes" or variations of such words including negative variations thereof and phrases that refer to certain actions, events or results that may, could, would, might or will occur or be taken or achieved. Forward-looking statements are based on certain assumptions regarding PreveCeutical, including expected growth, results of operations, including PreveCeutical's research and development activities, performance, industry trends, growth opportunities, that PreveCeutical will be granted requisite expedited approvals by world health, retain and attract qualified research personnel, obtain and/or maintain the necessary intellectual property rights needed to carry out future business activities, and that the benefits and impacts arising from the Option Agreement and the final terms of the license agreement will be consistent with the Company's expectations.

Actual results could differ from those projected in any forward-looking statements due to numerous factors including, risks and uncertainties relating to: the Company's involvement in the development of products utilizing the sol-gel technology, that the Company and Endosane will be unable to agree on terms for a license agreement, that the benefits and impacts arising from the Option Agreement and a license agreement will be consistent with the Company's expectations, complexities and delays in connection with research and development activities and the actual results of research and development activities; the ability of PreveCeutical to, among other things, protect its respective intellectual property, obtain any required governmental, regulatory or stock exchange approvals, permits, consents or authorizations required, including Canadian Securities Exchange acceptance of any planned future activities and obtaining expedited requisite approvals from world health agencies; and the ability of PreveCeutical to commercialize products, pursue business partnerships, complete their research programs as planned, and obtain the financing required to carry out their planned future activities. Other factors, such as general economic, market or business conditions or changes in laws, regulations and policies affecting the biotechnology or pharmaceutical industry may also adversely affect the future results or performance of PreveCeutical. These forward-looking statements are made as of the date of this news release and, unless required by applicable law, PreveCeutical assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in these forward-looking statements. Although PreveCeutical believes that the statements, beliefs, plans, expectations, and intentions contained in this news release are reasonable, there can be no assurance that those statements, beliefs, plans, expectations, or intentions will prove to be accurate. Readers should consider all of the information set forth herein and should also refer to other periodic reports provided by PreveCeutical from time-to-time. These reports and PreveCeutical's filings are available at www.sedarplus.ca. Neither the Canadian Securities Exchange (CSE or CNSX Markets), its Regulation Services Provider (as that term is defined in policies of the CSE), nor any other regulatory authority accepts responsibility for the adequacy or accuracy of this release.

Any link in this press release to external information or other resources is provided for reference only, and such information or resources might change from time to time, and may include forward-looking statements as described above, and are subject to the above disclaimers under this heading forward-looking statements.

Readers are cautioned that forward-looking statements are not guarantees of future performance or events and, accordingly, are cautioned not to put undue reliance on forward-looking statements due to the inherent uncertainty of such statements.

SOURCE PreveCeutical Medical Inc