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Tetra Bio-Pharma Begins Clinical Trials

Ryan Allway

February 28th, 2017

News, Top News

The cannabis industry is expected to surpass $24 billion by 2025, according to New Frontier Data, a cannabis market research and analytics firm. Despite the legalization of recreational marijuana, medical use is still expected to account for roughly half of total revenue in 2025, driven by promising new research into the potential of cannabinoids. Surprisingly, only a handful of public companies are actually beginning clinical trials of cannabis and cannabinoids.

In this article, we will take a closer look at Tetra Bio-Pharma Inc. (CSE: TBP) (OTC: GRPOF) and its progress in advancing clinical trials in the United States and Canada.

Canadian Phase 1 Trial Begins

Tetra Bio-Pharma recently announced that the Therapeutic Products Directorate (“TPD”) of Health Canada approved its Phase I clinical study of PPP001 covering smoked cannabis for the management of uncontrolled pain in cancer and AIDS patients. The announcement was followed one week later by the beginning of the trial, as Tetra was clearly ready to get going. The trial is a first study approved that could eventually lead to approval of the product as a prescription drug. The study assesses single and 7-day multiple daily ascending doses of smoked cannabis on the cognitive function in healthy adults.

It is the first development program aiming to obtain prescription drug approval and government provided insurance coverage for medical marijuana patients. If successful, the approval would set Tetra apart from all other medical marijuana providers who cannot get government provided insurance coverage and reimbursement for their patients. This could prove to be a major value driver for the company, as the lack of reimbursement is a serious obstacle for many patients seeking treatment.

“This trial is part of Tetra’s commitment to develop medical cannabis as a prescription drug for patients. The outcome of this trial is going to have significant implications in medical cannabis research as it is a first pharmaceutical clinical trial assessing the effects of smoked cannabis on cognitive function in healthy volunteers,” said Mr. Andre Rancourt, Chief Executive Officer of Tetra Bio-Pharma in a recent press release.

The company worked with Algorithme Pharma, an Altasciences company, to develop the clinical trial application. Algorithme Pharma has already begun recruiting subjects for the trial, which is expected to last 3 to 4 months.

Discussions with the FDA

Tetra Bio-Pharma also recently completed a pre-IND meeting with the United States Food & Drug Administration (“FDA”) Division of Anesthesia, Analgesia, and Addiction Products (“DAAAP”) Center for Drug Evaluation and Research (“CDER”) in late-January. During the meeting, the FDA provided guidance on the design of Phase I clinical trials and the overall program, while validating that the company was on the right track.

“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 corporations plan to seek reimbursement by insurers for patients.”

With the path clearly defined, the company plans to apply for marketing approval in both the United States and Canada by early 2019. The interim data from the Phase I clinical trials could provide a solid catalyst for the stock, while Phase II clinical trial results could be an important precursor to commercialization partnerships. These partnerships and/or a commercial launch could unlock significant value for shareholders.

There is a further point to consider regarding cannabinoid drug development in the United States. Last week, White House press secretary Sean Spicer indicated that the federal government could be expected to step up enforcement of federal recreational cannabis laws, presumably in the face of various state laws permitting recreational use. The comment caused widespread concern in the industry. Whether the comment results in action or not, investors should note that development of cannabinoid based drugs should not be affected as it has nothing to do with recreational legalization. Additionally, Mr. Spicer reinforced the idea that the current administration is supportive of medical marijuana use.

Looking Ahead

Tetra Bio-Pharma Inc. (CSE: TBP) (OTC: GRPOF) has made solid progress in advancing its clinical trials throughout the United States and Canada. With a $12+ billion market up for grabs, the company is one of just a handful of public companies that have started clinical trials in the cannabis industry. Investors may want to take a closer look at the company given these near-term catalysts and the potential to have a product on the market by 2020.

For more information, visit the company’s website or CannabisFN’s company profile.

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.

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CFN Enterprises Inc. (OTCQB: CNFN) owns and operates CFN Media Group, the premier agency and financial media network reaching executives, entrepreneurs and consumers worldwide. Through its proprietary content creation, video library, and distribution via www.CannabisFN.com, CFN has built an extensive database of cannabis interest, assisting many of the world’s largest cannabis firms and CBD brands to build awareness and thrive. For more information, please visit www.cfnenterprisesinc.com.

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