Tetra Bio-Pharma announced the advancement of its collaboration with Storz & Bickel for the development of a fibromyalgia treatment combining Tetra’s investigational medical cannabis product PPP001 and Storz & Bickel’s vaporizer Mighty Medic.
The study protocol designed to investigate the therapy was approved by a Canadian independent ethics board, and was recently submitted for review to Health Canada, which controls medicine approval and commercialization in Canada.
“The Independent Ethics Board approval represents a major step forward prior to obtaining approval from Health Canada and the clinical study will allow Tetra to accelerate bringing PPP001 for fibromyalgia patients,” Guy Chamberland, PhD, chief executive and scientific officer at Tetra Bio-Pharma, said in a press release.
Tetra Bio-Pharma is a biopharmaceutical company focused on the discovery and development of cannabinoid-based therapies, as products derived from cannabis have been shown to offer pain relief.
Tetra’s PPP001 is an inhaled medical cannabis product developed to treat patients with advanced cancer pain, and is being tested in Phase 2/3 trials.
In July this year, Tetra announced a collaboration with Storz & Bickel to test the investigational PPP001 therapy in patients with fibromyalgia for pain relief.
Storz & Bickel built the first factory in the world to manufacture medical herbal vaporizers, in the German town of Tuttlingen. Mighty Medic is the first certified battery-powered medical herbal vaporizer. The collaboration is aimed at combining the inhaled medical cannabis PPP001 product with the Mighty Medic vaporizer.
Tetra is working on identifying all the compounds present in the cannabinoid-based PPP001 vapor generated by the Mighty Medic. Results are expected this fall.
Later this year, Tetra plans to begin a Phase 1 clinical study to investigate the safety and pharmacokinetics (distribution of the medicine in the body) of the vaporized PPP001 therapy in healthy individuals.
Data from PPP001 trials and the identification of vapor compounds will allow Tetra to accelerate the development of the drug into Phase 3 trials. This way, the company can significantly cut time to market and development costs for the commercialization of PPP001 as a fibromyalgia treatment.
“We are very confident in Tetra’s strategy to become a global leader in the development of cannabinoid derived-prescription and natural health products,” Chamberland said.