Wednesday, May 22, 2024

First Clinical Trial Of Marijuana For Cancer Pain Entering Phase III

Medical cannabis has gained widespread acceptance throughout North America, but many physicians are still hesitant to prescribe the drug without evidence from clinical trials. While many companies are developing synthetic drugs based on cannabinoids, there are some companies that remain committed to realizing the synergistic capabilities of the whole cannabis plant and proving its therapeutic benefit.

In this article, we will look at Tetra Bio-Pharma Inc. (CSE: TBP) (OTCQB: TBPMF) and its recent progress in bringing its smokable marijuana therapeutic to market.

Smokeable Cannabis Trial

Tetra Bio-Pharma’s PPP001 is the first smokeable cannabis drug product being developed for the treatment of pain in late-stage cancer patients. According to Global Pain Management, approximately 50% of cancer patients suffer from pain and more than 600,000 of these patients suffer from moderate-to-severe pain. The overall market for pain-related therapeutics is valued at over $5 billion with over four million cancer patients in the United States alone.

If approved by the FDA, the company’s PPP001 will be sold as a titanium pipe and blister pack containing drug pellets with a standardized amount of delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). A single drug pellet is pushed out of the blister pack, inserted into the titanium pipe, and smoked to deliver the active ingredients. Management anticipates securing marketing approval in Canada and the United States by early 2019.

The development of PPP001 will confirm the efficacy of smoked cannabis in treating underlying medical conditions and essentially validate the use of medical marijuana. At the same time, patients would be able to access the ‘raw’ form of the drug (as opposed to synthetic versions) with a prescription that may be covered by health insurance. These dynamics could make medical cannabis much more affordable for patients and credible in the eyes of doctors.

Making Significant Strides

Tetra Bio-Pharma recently announced the completion of its Phase I safety and pharmacokinetics report for PPP001 and its submission to Health Canada. The data demonstrated that the inhalation of PPP001 achieved the targeted plasma level of THC that could potentially achieve pain relief in cancer patients without the use of opioids. The company will continue to complete the research needed to ensure that the drug conforms to regulatory requirements.

“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 Tetra Bio-Pharma CEO Andre Rancourt in the press release announcing the news.

The company simultaneously announced preparation for a Phase III clinical trial in collaboration with Quebec’s leading medical cannabis clinic, Sante Cannabis. Management anticipates that the new clinical trial will be launched by the fourth quarter of this year or the first quarter of next year. In May, the company met with Health Canada and received feedback and guidance on this critical trial and its plans to secure approvals for PPP001.

Looking Ahead

Tetra Bio-Pharma Inc. (CSE: TBP) (OTCQB: TBPMF) represents a compelling investment opportunity within the cannabis industry. With its PPP001 program, the completion of Phase I clinical trials and the preparation for Phase III clinical trials marks an important milestone for the company and its shareholders. Investors may want to keep a close eye on the company as it gears up to advance these trials and bring the first smokeable cannabis to market.

In addition to PPP001, the company has several other clinical programs in its pipeline that could generate incremental shareholder value. PPP002 is a Dronabinol-based mucoadhesive wafer designed to manage anorexia and cancer chemotherapy-related pain; PPP003 is a combination product targeting chronic pain, PTSD, and other conditions; PTGR is a topical prescription drug for pain management; and, AGT001 is another topical product for pain management.

This story originally appeared on Cannabis FN.


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