PhytoPain, a subsidiary of Tetra BioPharma (CSE:TBP) has announced the launch of its Double-Blind Phase I Study.
As quoted in the press release:
The Phase I clinical research is a classical pharmaceutical study in the development of a new drug. The trial activities will occur over a 3 to 4-month period and involve site initiation, subject recruitment and enrolment, a single daily ascending dose phase and a 7-day multiple daily ascending dose phase, followed by study termination. Algorithme Pharma has already begun recruiting subjects for the Phase I trial. This study is a pivotal safety trial as it will allow Tetra to understand the adverse effects of smoking Cannabis and associate the outcomes, such as cognitive function, to plasma levels of THC and CBD. The study will provide Tetra with the data necessary to discuss with Health Canada and FDA the potential risks in patient populations and discuss marketing requirements for specific indications.
The pharmacokinetic profile and safety data generated by the Phase I trial will allow Tetra to finalize the design of its Phase II-III clinical trial that will assess the safety and efficacy of PPP001 in cancer patients with uncontrolled pain. PPP001 is being developed for cancer patients with moderate-to-severe pain and that are not adequately controlled with the standard of care. Approximately 50% of cancer patients suffer from pain and more than 600,000 of these patients suffer from moderate-to-severe pain. In the USA, there are over 4 million cancer patients and this pain market is valued at over $5 billion USD.
“We are very pleased to announce that the start of the Phase I clinical trial activities as this keeps the company on track in its development of PPP001”, commented Mr, Andre Rancourt. “With PPP001 and the mucoadhesive AdVersa® controlled-release tablet, Tetra is positioning itself to become a major player in the cancer pain therapy market,” added Mr. Rancourt.