This represents the first ever human clinical trial featuring a vaporized cannabinoid drug product
OTTAWA, Nov. 01, 2018 (GLOBE NEWSWIRE) — Tetra Bio-Pharma Inc. (“Tetra” or “TBP”) today announced that is has received a “No Objection Letter” (NOL) from the Therapeutic Drug Directorate at Health Canada to conduct a Phase 1 pharmacokinetic (PK) and safety study using a vaporized version of PPP001.
This study aims to determine the Pharmacokinetic and safety profile of PPP001 delivered as an inhaled vapour using the Mighty Medic (see previous July 16, 2018 News Release), thus providing patients with an alternative to the smoked version of PPP001 and allowing Tetra to develop PPP001 for healthier patients suffering from uncontrolled pain. It is anticipated that this phase 1 data, combined with Tetra’s characterization of the composition of vapor, will provide the necessary evidence to advance the development of vaporized PPP001 into more chronic and non-life-threatening diseases, such as fibromyalgia. The study is expected to begin and end in Q4 2018.
“We are pleased to announce this critical Phase 1 trial focused on the PK and safety of our PPP001 pellet delivered by vaporization,” said Dr. Guy Chamberland, CEO and CSO of Tetra Bio-Pharma Inc. “Over the last 3 months we have analyzed the composition of the vapor. 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 there is a large unmet medical need. It may also provide an alternative mode of delivery for those patients who prefer not to smoke.”
About Tetra Bio-Pharma
Tetra Bio-Pharma (TSX-V: TBP) (OTCQB: TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and development with a Health Canada approved, and FDA reviewed, clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. The Company 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. With patients at the core of what we do, Tetra Bio-Pharma is focused on providing rigorous scientific validation and safety data required for inclusion into the existing bio pharma industry by regulators, physicians and insurance companies. For more information visit: www.tetrabiopharma.com
Source: Tetra Bio-Pharma
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|For further information, please contact Tetra Bio-Pharma Inc.|
|Executive Vice-President Corporate Development and Licensing|
|Carol Levine||Stephanie Engel|
|514-288-8500 ext. 226||416-425-9143 ext. 209|
Source: Tetra Bio-Pharma Inc