Tetra Bio-Pharma receives Health Canada Phase 3 clinical trial approval for smokable dried cannabis prescription drug.
Tetra Bio-Pharma Inc., a cannabinoid-based drug development and discovery company, 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.
Coinciding with World Cancer Day 2018, Tetra is now ready to initiate its Phase 3 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,” said Bernard Fortier, Tetra’s CEO, “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. The advanced cancer pain market is a $2.4B market1; 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 Sante Cannabis, Quebec’s first medical clinic and resource centre specializing in cannabis and cannabinoids for medical purposes.
The PPP001 Phase 3 trial will evaluate the effects of Tetra’s smokable cannabinoid-based drug made from natural dried cannabis. Tetra previously entered into a supply agreement with Aphria Inc., to use Aphria’s unique blend of dried medical cannabis in its PPP001 clinical trial. Aphria owns an 8.5 percent stake in Tetra.
As part of the clinical trial, Tetra will also collect the pharmaco-economics evidence required from insurers in order to support the reimbursement of the first cannabis prescription drug.
“Today, most private insurance plans do not cover cannabis treatment, nor is public reimbursement available, making this therapeutic option costly for patients,” commented Bernard Fortier, CEO. “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 eases suffering and facilitates a more serene experience of living and dying in terminal cancer patients. If conclusive, Tetra will submit a filing for a Drug Identification Number (DIN) to Health Canada in 2019, thus providing a new noninvasive treatment to relieve pain for the cancer patient. With this approval, Tetra expects to be on time with its previously announced schedule with the development of PPP001, culminating in a potential launch in Canada by Q1, 2020 and in the U.S. by Q3, 2020.
Dr. Guy Chamberland, Tetra’s chief scientific officer (CSO) explained that: “The development of PPP001 for patients with advanced cancer is an important commitment for Tetra, given that cancer patients suffer from severe pain which is often accompanied by depression and insomnia. Medical cannabis has been shown to help patients beyond the immediate benefit of pain relief.”
Chamberland added, “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.”
Tetra worked with Sante 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 a first indication in patients with advanced cancer. The Phase III clinical trial will be performed by the medical team of Sante Cannabis.
(Source: Tetra Bio-Pharma)
Filed Under: Drug Discovery