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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