Tetra Bio Pharma Inc (TBPMQ)

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Tetra Bio-Pharma Inc.
TSX VENTURE : TBP
OTCQB : TBPMF

Tetra Bio-Pharma Inc.
January 16, 2018 08:00 ET

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