Tetra Bio-Pharma Receives Health Canada Phase 3 Clinical Trial Approval For Smokable Dried Cannabis Prescription Drug - Seite 2

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 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 US 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."

"With the expertise of Santé Cannabis, we expect to demonstrate the clinical benefits of PPP001 on the quality of life of advanced cancer patients. 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, " added Dr. Guy Chamberland.

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 a first indication in patients with advanced cancer. The Phase III clinical trial will be performed by the medical team of Santé Cannabis.

"Throughout my clinical experience assessing and following more than 600 medical cannabis patients, cannabis inhalation remains a critical option to provide rapid relief from a wide variety of symptoms associated with advanced cancer, " said Dr. Antonio Vigano, Principal Investigator of the trial and Research Director of Santé Cannabis. "We will rigorously assess the safety, efficacy and tolerability of PPP001 to support the population of cancer patients by bringing an important therapeutic tool to the same standard of prescription drugs It is great to be celebrating World Cancer Day 2018 with the first large scale clinical study to prove that medical cannabis can ease the suffering and improve quality of life of many cancer patients, particularly when they most need it."