Tetra Bio-Pharma (CSE:TBP; OTCQB:TBPMF) and subsidiary, PhytoPain Pharma, have submitted a report on the safety and pharmacokinetics of its PPP001 smokeable cannabis product to Health Canada.
The company also is preparing a Phase 3 clinical trial in collaboration with Quebec's leading medical cannabis clinic, Sante Cannabis, to start by the fourth quarter this year or first quarter next year.
PPP001 is the first smokeable cannabis drug product being developed for the treatment of late-stage cancer patients with pain.
After a detailed review of the clinical data, the company reported that safety data met its expectations and that the pharmacokinetic data demonstrated that the inhalation of PPP001 achieved the targeted plasma levels of THC that could potentially achieve pain relief in cancer patients.
In a statement, Andre Rancourt, CEO of Tetra, said that with the expertise of Sante Cannabis, “we expect to demonstrate the clinical benefits of PPP001 on the quality of life of advanced cancer patients. Importantly, our clinical program will also address the potential of PPP001 to reduce the reliance on opioids for management of severe pain,” he added.
In late May 2017, Tetra had a pre-submission consultation meeting with the Therapeutic Products Directorate of Health Canada to brief the agency on the safety findings and pharmacokinetics of PPP001, and to discuss its clinical development program leading to the submission of a New Drug Submission for a first indication in advanced cancer patients with pain. Health Canada provided feedback and guidance on Tetra's clinical development program and the proposed Phase 3 clinical trial.
The company also will be completing the research required to ensure that PPP001 conforms to the chemistry and manufacturing requirements under the Food and Drug regulations to secure its Notice of Compliance and a Drug Identification Number.