Tetra Bio-Pharma Inc. (TBPMF) Receives Health Canada Approval for Phase 2 Cannabis Oil Trial

“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 1^st 2016 and September 30^th 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.