Health Canada green light for next phase of first clinical trial with vaporized cannabinoid drug.

Tetra Bio-Pharma’s steady progression toward commercialization of its vaporized cannabinoid drug saw the company mark an important milestone today, with a green light from Health Canada to do a phase 1 clinical trial.

The clinical trial will begin and finish before year end.

Canadian cannabis giant Aphria, which today made its debut on the NYSE, owns 10-million common shares of Tetra and its CFO chairs the its audit committee as a director of Tetra’s board.

“We see enormous opportunity for our relationship with Tetra, both as a supplier and as a shareholder,” Aphria CEO Vic Neufeld said, during his quarterly update conference call with shareholders last month,.

THOROUGH ANALYSIS OF VAPOUR COMPOUND

Tetra CEO Guy Chamberland said a thorough analysis of the vapour’s composition was recently completed.

“This data, combined with the results of this phase 1, will provide the critical pharmacological information required by physicians to adequately guide future efficacy studies in patients who suffer from a chronic condition such as fibromyalgia, where there are limited treatment options and a large unmet medical need,” said Tetra’s CEO and CSO

“It may also provide an alternative mode of delivery for those patients who prefer not to smoke.” 

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.

FDA SUBMISSIONS

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 

Aphria CEO Vic Neufeld, during the company’s quarterly update last month, told investors:

 “We maintain a supply contract with TBP for two products which they are performing clinical trials on – PPP001, a compressed dried flower product that is smoked, and PPP005 – an oil based product that is delivered with a syringe in the mouth.”

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 DIN (Drug Identification Number).

EUROPE

The company 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.

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.

 

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