By: Ryan Allway – February 14th, 2017
View Original: CFN Media Group
Medical marijuana may be legal for roughly 60% of the U.S. population, but the cost of the drug remains prohibitive for many patients in need. Tetra Bio-Pharma Inc. (CSE: TBP) (OTC: GRPOF) aims to undergo FDA-sanctioned clinical trials for dried medical marijuana to secure prescription drug coverage from insurance companies. If successful, the company could potentially reach a large patient population with a unique option.
CFN Media recently spoke with Chief Science Officer Dr. Guy Chamberland about the company’s progress:
In this article, we will take a closer look at some of the company’s recent milestones and why investors may want to consider the stock for their portfolios.
FDA Clears Way for Phase I Trials
Tetra Bio-Pharma held a pre-Investigational New Drug (“IND”) meeting with the U.S. Food and Drug Administration (“FDA”) in late January to advance its PPP001 clinical trial. During the meeting, the FDA provided all the necessary guidance on the design of a Phase I clinical trial on healthy volunteers and its overall development program. The meeting further demonstrates the agency’s willingness to continue the clinical trial to develop a dried marijuana prescription drug.
“We could not be more pleased, as the FDA guidance gave us a clear path to progress from early to late phase clinical development,” said Dr. Chamberland, M.Sc., Ph.D., Chief Scientific Officer and Regulatory Affairs. “Adhering to the U.S. FDA regulations is part of Tetra Bio-Pharma’s dedication to the commercialization of cannabis as a prescription controlled drug and the corporation’s plan to seek reimbursement by insurers for patients.”
PPP001 is a dried cannabis product with 9.5% tetrahydrocannabinol (“THC”) and 2% cannabidiol (“CBD”) that is being developed as a prescription drug that will meet the FDA’s high bar for quality and manufacturing. The company’s goal is to be the first to achieve reimbursement from insurance companies for the cost of the prescription, which could prove to be a game-changer for would-be medical marijuana patients that cannot afford the drug.
Enhancing the Odds of Success
Tetra Bio-Pharma recently partnered with Sante Cannabis in Montreal to assist in developing its clinical trials. As a leading private medical marijuana clinic, the organization has years of experience in educating patients and ensuring the optimal benefits. The company aims to leverage this expertise to ensure that its clinical trials are properly designed to achieve desired outcomes while helping achieve the organization’s goal of lowering costs for patients.
“Our clinic has provided services to almost 2,000 patients referred by over 1,500 physicians across Québec,” said Erin Prosk, Director of Santé Cannabis. “It is clear that both the medical community and the Quebec patient population are in desperate need of information about the potential benefits and risks of medical cannabis treatments … Of the 2,000 patients that we have seen, there is not one who is not burdened by [the cost of medical marijuana].”
These efforts are supported by an exceptional Scientific Advisory Board comprised of experts in clinical research, pain management, cancer, and neurological product drug development. Recently, the company expanded the board to include Dr. Gilles Chamberland, MD,FRCPC (no relation to Dr. Guy Chamberland) who will provide critical guidance on PPP’s clinical development program with regards to the safety of cannabis drug products and the potential mental health risks associated with marijuana.
Tetra Bio-Pharma Inc. (CSE: TBP) (OTC: GRPOF) continues to advance towards clinical trials for its PPP001, which aims to become the first dried marijuana prescription drug. After a successful pre-IND meeting and new partnership with the Sante Cannabis clinic, the company has assembled the right conditions to properly execute a clinical trial, significantly lower the cost of medical marijuana for patients, and unlock significant value for shareholders.
For more information, visit the company’s website