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REPORTS APPROVAL BY HEALTH CANADA OF ITS PHASE I TRIAL OF PPP001 (DRIED CANNABIS)

 

The therapeutic products directorate (TPD) of Health Canada has approved PhytoPain Pharma Inc.'s (TBP.C) phase I clinical study of smoked cannabis. PhytoPain is a subsidiary of Tetra Bio Pharma Inc.

Tetra has worked with Algorithme Pharma, an Altasciences company, for the preparation of the Clinical Trial Application (CTA) for the conduct of a Double-Blind Phase I Study to Assess Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single and Multiple Daily Ascending Doses of Cannabis (Delta-9-tetrahydrocannabinol/ Cannabidiol) by Smoking/Inhalation in Healthy Male and Female Volunteers. The CTA was submitted to Health Canada and the research ethics review board in December 2016. On January 3, 2017, the clinical trial received approval from the Institutional Review Board. TPD issued a Letter of Authorization for the conduct of the Phase I clinical trial on February 16, 2017. Algorithme Pharma will be initiating the clinical trial activities in the coming weeks.

We are very pleased to announce the authorisation of the Phase I clinical trial by TPD. This is an important milestone in the clinical development of smoked Cannabis in North America and we are proud to be working with Algorithme pharma, a Clinical Research Organization with many years of experience and expertise in the conduct of Phase I clinical studies, Superscript 2 said Dr. Chamberland, Chief Science Officer.

"This trial is part of Tetra's commitment to develop medical Cannabis as a prescription drug for patients. The outcome of this trial is going to have significant implications in medical Cannabis research as it is a first pharmaceutical clinical trial assessing the effects of smoked Cannabis on cognitive function in healthy volunteers" said Mr. Rancourt, Chief Executive Officer

Earlier this month, Tetra and IntelGenx announced the co-development of Dronabinol AdVersatrademark Mucoadhesive controlled-release tablet for the management of Breakthrough Cancer Pain. The significant advantage of the Mucoadhesive technology was demonstrated in a Phase I clinical trial. The study demonstrated the delayed-release of THC avoids a rapid increase in the blood. Superscript 2With both of these products in clinical development, Tetra is on track with its objective to bring Cannabis-based prescription drugs to the market. Both of these products are promising alternatives in the battle for the reduction of opioids and improving quality of life in patients with chronic pain Superscript 2, added Dr. Chamberland.