Health Canada approval for a phase 1 clinical trial will allow Tetra Bio-Pharma to take the next step in commercializing its vaporized cannabis drug.
Data from the clinical trial, along with the recently completed analysis of the vapour’s composition, will help guide future efficacy studies in patients who suffer from a chronic condition such as fibromyalgia.
“It may also provide an alternative mode of delivery for those patients who prefer not to smoke.”
Dr. Guy Chamberland, Tetra Bio-Pharma CEO and CSO
The company’s FDA-reviewed and Health Canada approved clinical program aims to bring novel prescription drugs and treatments to patients and their healthcare providers.
INSURANCE PLAN COVERAGE
The company recently 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.
Tetra 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.
SUPPLY CONTRACT WITH APHRIA
Canadian cannabis company Aphria owns 10-million common shares of Tetra, and its CFO serves on Tetra’s board of directors. It also has a supply contract with Tetra for two products: a compressed dried-flower product (PPP001); and an oil-based product (PPP005) that is delivered with a syringe in the mouth.
Aphria CEO Vic Neufeld, during the company’s quarterly update last month, told investors:
“We see enormous opportunity for our relationship with Tetra, both as a supplier and as a shareholder,”
A head-to-head study on pain management for PPP001 against Fentanyl is one the “many interesting trials going on,” he said.
The drug is currently in Phase 3, he said, with the end goal being a Drug Identification Number.
Tetra has also announced acceleration 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.
It gives the company the legal and regulatory framework needed to submit its pre-marketing application for its cannabis drugs. Tetra said it intends to pursue a Full Market Authorisation since it has a dossier supporting the medicinal products’ quality, safety, and efficacy.
LUCRATIVE MARKET FOR PAIN 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.
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.
The company recently launched a Hemp Energy Drink from Kombucha Baby Brewing Company.