Tetra Bio-Pharma and its clinical research partner Santé Cannabis appear to be first in North America to begin and make substantial progress on a clinical trial using cannabis-oil capsules to treat chronic pain that is not related to cancer.
It’s the first-ever and most exhaustive study to evaluate the safety and efficacy of different doses and ratios of cannabis oils versus placebo.
The company today announced the clinical trial is on track to be completed this fall, with important information already coming in.
“The trial has already provided unique valuable clinical data on both safe and efficacious dose levels of CBD and THC-CBD oils,” said Dr. Guy Chamberland, Tetra Bio-Pharma’s CEO and chief scientific officer.
“This data will allow Tetra to advance to the next phase of product development wherein the company is developing products for its commercial partner Genacol Corporation Canada, as well as food supplements for the retail market and finally, our capsules that we intend to use in the treatment of chronic and cancer related pain,” he said.
“We continue to deliver on our business model that provides for evidence-based research to support the usage of cannabis-derived products and provide the medical community with the data they have been demanding from this sector.”
Independent Ethics Board approval – fibromyalgia treatment
The company last week announced Independent Ethics Board approval to continue developing a specially designed vaporizer to deliver its PPP001 drug to treat fibromyalgia.
Pending Health Canada approval, a phase-one clinical trial will be conducted after the company identifies every compound in the vapor later this month.
The company previously announced Health Canada’s decision to reclassify the vaporizer as a Class Two medical device, making it eligible for cost reimbursement from private and public-insurance plans.
The company is also awaiting decisions on multiple Orphan Drug Designation submissions to the U.S. Food and Drug Administration for products to treat rare cancers and ocular diseases.
The biopharmaceutical company has a Health Canada approved and FDA reviewed clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers.
Pre-marketing application in Europe
Earlier this month, the company announced it was accelerating the submission of a pre-marketing application for the registration of its cannabis drugs PPP001 and PPP005 under Directive 2001/83/EC of the European Parliament and of the Council.
The directive gives the company the legal and regulatory framework needed to submit its pre-marketing application for its cannabis drugs.
The company said it intends to pursue a Full Market Authorisation since it has a dossier supporting the medicinal products’ quality, safety, and efficacy.
Breaking into the lucrative market for inflammation-relief products
Tetra recently secured a new supply agreement with True North for high-quality, competitively priced CBD.
Through its agreement with Genacol Canada, the company plans to get its oral capsule and topical cream into the $2.5-billion market for joint-pain-and inflammation products.
Advanced and growing pipeline
Tetra Bio-Pharma has several subsidiaries engaged in the development of an advanced and growing pipeline of bio pharmaceuticals, natural health and veterinary products containing cannabis and other medicinal plant-based elements.
“Tetra has already established itself as a trailblazer in the natural health product segment with the announcement of our intention to launch a Hemp Energy Drink, and we intend to build on that momentum,” said Dr. Chamberland.