- Announced the approval by Health Canada of a Phase 2 clinical trial
- Designed to evaluate the safety and efficacy of different doses and ratios of medical cannabis oil (THC & CBD) to improve uncontrolled chronic pain in cancer and non-cancer patients
OTTAWA, ONTARIO–(Jan. 29, 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 the approval by Health Canada of a Phase 2 clinical trial designed to evaluate the safety and efficacy of different doses and ratios of medical cannabis oil (THC & CBD) to improve uncontrolled chronic pain in cancer and non-cancer patients.
“To our knowledge, this is the first Health Canada-approved phase 2, randomized, double-blind, placebo-controlled clinical trial using encapsulated medical cannabis oil in Canada,” said Bernard Fortier, Tetra Bio-Pharma’s CEO. According to an Eight Capital analysis1, the cannabis oil market is expected to reach 1.5B$ in 2024.
“This is a significant milestone in our mission to become a global bio-pharmaceutical leader in cannabinoids-based drug development. We currently have a strong pipeline of five cannabinoid-based products, all launched last year and using different delivery systems, in various stages towards Health Canada and FDA approval.”
The Phase 2 trial will be conducted with Montreal-based Santé Cannabis, Quebec’s first medical clinic and resource centre specializing in cannabis and cannabinoids for medical purposes.
According to Health Canada data2, 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.
Dr. Guy Chamberland, Tetra’s Chief Scientific Officer (CSO), also commented that “there is limited scientific and clinical information on the different doses and ratios of medical cannabis oil in the management of pain. This type of clinical trial is required to generate the urgently needed safety and efficacy data required by physicians and pharmacists for the adequate care of patients”.
“We are excited to launch this trial to build the evidence base for medical cannabis in chronic pain, and to demonstrate the leadership of Santé Cannabis on the world stage” said Dr. Antonio Vigano, Research Director of Santé Cannabis and McGill University Associate Professor of Oncology. “At Santé Cannabis, our team observes the impact that cannabis oil has for our patients. For many, medical cannabis can reduce or even eliminate the need for other pharmacological medications. As clinicians and researchers, we must pursue these critical steps to quantify its benefits and to investigate potential risks.”
These studies are part of the Company’s sales and marketing strategy required to effectively penetrate a physician-pharmacist market. The outcome of these studies will also support Tetra’s overall drug development strategy and it is expected that this will allow Tetra to reduce the overall time-to-market for a number of its cannabinoids-based prescription drugs. The company will also use this data to create novel new products that will allow Tetra to further increase its share in the cannabis oil market.
Last year, Tetra launched a number of drug development programs that are expected to lead to the commercialization of cannabinoid-based prescription drugs, making it one of the world leaders in cannabinoid pharmaceuticals. Tetra’s vision is to develop an evidence-based approach similar to that of any other prescription drug, thereby allowing physicians to prescribe, and pharmacists to dispense, these medicines to patients in need.
After receiving approval of a phase 1 clinical trial for its PPP005 cannabis oil program in mid-January of this year, Tetra is now launching a phase 2 trial to assess if cannabis oil treatment will reduce the amount of concurrent pain medications and the need for rescue medications to control chronic cancer and non-cancer pain. This phase 2 clinical trial is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety and efficacy of different doses and ratios of medical cannabis oil. In addition, the study will evaluate the effects on improving symptom burden and on cognition and mood in those chronic pain patients.
Tetra and Santé Cannabis have been preparing for several months to initiate this clinical program. The team at Santé Cannabis has grown to include qualified and experienced personnel in the conduct of clinical trials in compliance with Good Clinical Practices. This trial is driven by the medical experts of Santé Cannabis and will provide much needed safety and efficacy data in this patient population, as well as provide Tetra with critical knowledge of the benefits of different ratios of THC and CBD in pain management.
1: Cannabis Sector, Eight Capital Estimates, July 2017
2: Health Canada Market Data, [https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-use-marijuana/licensed-producers/market-data.html]
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
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Forward-looking statements
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.
Tetra Bio-Pharma Inc.
Dr. Anne-Sophie Courtois, DVM
Vice President, Marketing & Communications
(514) 360-8040 Ext. 210
[email protected]
