Tetra Bio-Pharma Receives Approval from Health Canada of its Phase 1 Clinical Trial with PPP005 (Cannabis Oil)
OTTAWA, ONTARIO–(Marketwired – Jan. 16, 2018) - Tetra Bio-Pharma Inc. (“Tetra” or the “Company“) (TSX VENTURE:TBP)(OTCQB:TBPMF), a global leader in cannabinoid-based drug development and discovery, is pleased to announce that it has received a No Objection Letter (NOL) from the Therapeutic Products Directorate (TPD), Health Canada to evaluate the safety, pharmacokinetics and pharmacodynamics of its cannabis oil PPP005.
According to Health Canada data1, the annual Canadian cannabis oil production for medical purposes was 22,766 kg between October 1st 2016 and September 30th 2017, and is growing continuously. In the third quarter of 2017, it grew 24% from Q2 (Apr-Jun) to Q3 (Jul-Sep)1. According to an Eight Capital analysis2, the cannabis oil market is expected to reach 1.5B$ in 2024.
The launch of this trial is the first step in Tetra’s plans to commercialize natural health products with its partners. The corporation will develop cannabis-based supplements for commercialization under the Natural Health Product regulations in Canada and in other countries where regulatory authorities have a recognized pathway for approval and commercialization of such products. The trial will eventually include formulations that will be registered as drugs under Health Canada’s TPD regulatory pathway. “Tetra Bio-Pharma Inc. seeks to become an important player in the retail market post legalization and this clinical trial is part of the sales and marketing strategy required to effectively penetrate the lucrative pharmacy and health stores retail markets,” states Bernard Fortier, CEO of Tetra.
Tetra’s vision is to develop an evidence-based approach, thereby allowing pharmacists to dispense these medicines to patients in need. Despite the growing popularity of cannabis oils, physicians and pharmacists across Canada are still hesitant to support the use of these products because of the lack of data supporting its medical use. Dr. Guy Chamberland, Chief Science Officer, commented: “This trial is part of Tetra’s corporate strategy to develop the science required to commercialize safe and efficacious cannabis oil products post-legalization and to create innovative oral drug formulations for the development of medicines in the management of pain, anxiety and the treatment of cancer.”
In that respect, Tetra’s scientific team is supporting the strategy by initiating a phase 1 clinical trial to characterize the safe use of these cannabis oil medicines in humans. Tetra has worked with Altasciences Clinical Research for the preparation of the Clinical Trial Application (CTA) for the conduct of a double-blind phase 1 study to assess safety, tolerability and pharmacokinetics of single and multiple daily doses of cannabis (Delta-9-tetrahydrocannabinol/Cannabidiol) oil capsules administered to healthy human volunteers. Health Canada issued a No Objection Letter for the conduct of the phase I clinical trial on January 12nd, 2018. Altasciences Clinical Research will be initiating the clinical trial activities in the coming weeks. The cannabis oil is manufactured by Tetra’s partner, Aphria Inc.
|1:||Health Canada Market Data, [https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-use-marijuana/licensed-producers/market-data.html]|
|2:||Cannabis Sector, Eight Capital Estimates, July 2017|
About Tetra Bio-Pharma:
Tetra Bio-Pharma (TSX VENTURE:TBP)(OTCQB:TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and clinical development. Tetra is focusing on three core business pillars: clinical research, pharmaceutical promotion and retail commercialization of cannabinoid-based products.
More information at: www.tetrabiopharma.com
Source: Tetra Bio-Pharma
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Some statements in this release may contain forward-looking information. All statements, other than of historical fact, that address activities, events or developments that the Company believes, expects or anticipates will or may occur in the future (including, without limitation, statements regarding potential acquisitions and financings) are forward-looking statements. Forward-looking statements are generally identifiable by use of the words “may”, “will”, “should”, “continue”, “expect”, “anticipate”, “estimate”, “believe”, “intend”, “plan” or “project” or the negative of these words or other variations on these words or comparable terminology. Forward-looking statements are subject to a number of risks and uncertainties, many of which are beyond the Company’s ability to control or predict, that may cause the actual results of the Company to differ materially from those discussed in the forward-looking statements. Factors that could cause actual results or events to differ materially from current expectations include, among other things, without limitation, the inability of the Company, through its wholly-owned subsidiary, GrowPros MMP Inc., to obtain a license for the production of medical marijuana; failure to obtain sufficient financing to execute the Company’s business plan; competition; regulation and anticipated and unanticipated costs and delays, the success of the Company’s research strategies, the applicability of the discoveries made therein, the successful and timely completion and uncertainties related to the regulatory process, the timing of clinical trials, the timing and outcomes of regulatory or intellectual property decisions and other risks disclosed in the Company’s public disclosure record on file with the relevant securities regulatory authorities. Although the Company has attempted to identify important factors that could cause actual results or events to differ materially from those described in forward-looking statements, there may be other factors that cause results or events not to be as anticipated, estimated or intended. Readers should not place undue reliance on forward-looking statements. While no definitive documentation has yet been signed by the parties and there is no certainty that such documentation will be signed The forward-looking statements included in this news release are made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities legislation.
Dr. Anne-Sophie Courtois, DVM
Vice President, Marketing & Communications
(514) 360-8040 Ext. 210