After a detailed review of the clinical data, the Company is pleased to announce that the 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. The Phase I trial provides the key information required by the medical experts of Santé Cannabis to design a Phase III clinical trial for cancer patients. The Company expects to launch the Phase III clinical trial by Q4/17 – Q1/18.
“Shareholders should be proud to know how quickly we have moved through the Phase I trial and we are now progressing on an accelerated path to the Phase III trial which is, relatively speaking, a tremendous accomplishment for the organization and a testament of the excellent work undertaken by Dr. Chamberland and his team,” said Andre Rancourt CEO of Tetra Bio-Pharma. “Tetra has achieved a significant milestone in the execution of its business plan of becoming a global leader in pharmaceutical cannabis.”
“The development of PPP001 for patients with advanced cancer is an important commitment for Tetra. Cancer patients suffer from severe pain which is often accompanied by depression and insomnia. Medical marijuana 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. Importantly, our clinical program will also address the potential of PPP001 to reduce the reliance on opioids for management of severe pain. The Company will continue to maintain a transparent and direct line of communication with Health Canada (Therapeutic Products Directorate and Controlled Drug Substances) and the U.S. FDA to ensure that we address the issues required for drug approval. PPP001 is about patients first,” commented Dr. Chamberland CSO of Tetra Bio-Pharma.
In late May 2017, Tetra had a pre-submission consultation meeting with the Therapeutic Products Directorate (TPD) 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 III clinical trial.
Tetra and Santé Cannabis 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. “Medical cannabis has clear potential for the treatment of cancer pain that is partially or not responsive to opioid therapies and other analgesics,” states Dr. Antonio Vigano, lead trial physician and Research Director of Santé Cannabis. “It is our obligation to confirm the safety, efficacy and tolerability of PPP001 and to ensure that we are helping cancer patients by offering every possible tool to control pain and improve quality of life.”
The Company 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 (DIN).
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The post Tetra Bio-Pharma Inc. (TBP) (TBPMF) Announces the Completion of its Phase 1 Safety Report to Health Canada appeared first on Marijuana Stocks | Cannabis Investments and News. Roots of a Budding Industry.™.