Tetra Bio-Pharma Inc. announces that its Phase I trial of inhaled marijuana in healthy volunteers will be performed by Algorithme Pharma, an Altasciences company.
Tetra Brio-Pharma Inc., through its wholly-owned subsidiary, PhytoPain Pharma Inc. (PPP), a pharmaceutical company focused on developing and commercializing therapeutic cannabis-based products for the treatment of pain and other medical conditions, has selected Algorithme Pharma, an Altasciences company, for the conduct of its Phase I clinical trial in healthy human subjects. PPP is using the services of Algorithme Pharma based on its experience and expertise in the conduct of clinical trials for the pharmaceutical industry.
According to Dr. G. Chamberland, Chief Scientific Officer, “Adequately evaluating the safety of inhaled marijuana requires well-equipped clinical research facilities and investigational teams experienced in handling the administration of investigational drugs by inhalation to human volunteers. A fully assembled medical device, PPP001-titanium pipe, will be used for combustion of the marijuana and subsequent inhalation of the generated smoke.”
“We are proud to have been selected by PPP for their Phase I trial. We have partnered closely with PPP to design a unique Phase I trial in healthy human subjects to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple daily ascending doses of the company’s PPP001 inhalation marijuana investigational drug product.” explained Dr. Graham Wood, Executive Vice President, Phase I Clinical Development, at Algorithme Pharma.
Dr. Chamberland further commented that this regulatory filing is part of PPP’s dedication to the commercialization of marijuana as a prescription controlled drug and the Company’s plan to seek reimbursement by insurers for patients. He added that this Phase I trial will only begin after approval of the Clinical Trial Application (CTA) by the Therapeutic Products Directorate, Health Canada, Research Ethics Board approval, and obtaining an exemption from the Office of Controlled Substances for the conduct of the study.
Filed Under: Drug Discovery