Tetra Bio-Pharma Inc., a global leader in cannabinoid-based drug development and discovery, announces that it has received a No Objection Letter (NOL) from the Therapeutic Products Directorate (TPD) Health Canada to its Clinical trial application (CTA) for the Company’s PPP001 prescription smokable dried cannabis product.
The company is now ready to initiate its Phase III clinical trial of PPP001 in terminal cancer patients, the first registration trial in the world for smokable cannabinoid-based drug. This trial is expected to be a landmark study, enrolling a total of 946 subjects, evaluating the therapeutic benefits of a cannabinoid prescription drug in improving quality of life and treating pain in terminal cancer patients.
“This is an especially significant and noteworthy milestone for the lead candidate in our product pipeline, as it positions Tetra to potentially be the first company with a Health Canada approved, cannabinoid-based drug on the market aimed at treating breakthrough pain in cancer patients,” says Bernard Fortier, Tetra’s CEO. “The advanced cancer pain market is a $2.4 billion market. This is a significant and important opportunity for the company as our drug PPP001 has the potential to help reduce the reliance on opioids for the management of severe pain.”
The first and main recruitment center of the trial will be in Montreal at Santé Cannabis, Québec’s first medical clinic and resource centre specializing in cannabis and cannabinoids for medical purposes.
“Today, most private insurance plans do not cover cannabis treatment, nor is public reimbursement available, making this therapeutic option costly for patients,” says Fortier. “It is very important for us to bring a new therapeutic option for patients in the form of an approved prescription drug and to take action in order to have it reimbursed for patients.”
The trial aims to demonstrate that PPP001 will ease suffering and facilitate a more tranquil experience of living and dying in terminal cancer patients. If everything goes well, the company expects a launch in Canada in early 2020.
“With the expertise of Santé Cannabis, we expect to demonstrate the clinical benefits of PPP001 on the quality of life of advanced cancer patients,” says Dr. Guy Chamberland, Tetra’s chief scientific officer. “It’s important to note that our clinical program will also address the potential of PPP001 to reduce the reliance on opioids for management of severe pain. We expect that, once it is approved as a drug under prescription, PPP001 will be included over time ahead of opioids treatment for those patients with terminal cancer pain. The company will continue to maintain a transparent and direct line of communication with Health Canada and the U.S. FDA to ensure that we address the issues required for drug approval. PPP001 is about patients first.”
Tetra worked with Santé Cannabis physicians to design a clinical trial that would demonstrate the safety and efficacy of PPP001 in terminal cancer patients and have focused the clinical development on the first indication in patients with advanced cancer. The Phase III clinical trial will be performed by the medical team of Santé Cannabis.