Tetra Bio-Pharma and Alternavida have established a collaboration agreement to allow the clinical development, marketing, and distribution of the cannabis-derived medicine Caumz (PPP011) in Mexico.
This agreement will potentially accelerate the progression of two ongoing clinical trials testing Caumz while the company pursues approval in the U.S. and Canada. The Serenity Phase 3 trial is testing Caumz as a treatment for advanced cancer-associated pain, while another Phase 2 trial evaluates the medication’s safety and efficacy for fibromyalgia.
“We are thrilled to have signed this clinical development and commercialization agreement with Alternavida, as it provides non-dilutive funding for two clinical sites as well as a solid commercial footprint in Mexico, with the potential to expand to eight additional territories in Latin America,” Guy Chamberland, CEO and chief regulatory officer of Tetra, said in a press release. “Tetra will now be operating clinical sites in three countries: Mexico, Canada, and the U.S., boosting our enrollment potential.”
Caumz is an investigational non-opioid alternative to treat pain. It is an inhaled medical cannabis product, composed of pure synthetic tetrahydrocannabinol (THC) and cannabidiol (CBD).
According to the terms of the agreement, Alternavida will be a clinical research collaborator for the development of Caumz. The company will fully fund two additional clinical trial sites in Mexico for the Serenity (NCT04001010) and fibromyalgia trials.
The trials’ protocols and their participating clinical sites will be compliant with the rules and requirements imposed by the U.S. Food and Drug Administration and Health Canada, the two countries’ regulatory agencies. Both planned trials for Caumz are expected to start enrolling and treating participants in early 2020.
Alternavida also will be responsible for registering and commercializing Caumz in Mexico upon approval, and will be granted the opportunity to market Caumz in other eight countries in South America. These countries are Colombia, Ecuador, Chile, Panama, Costa Rica, Honduras, Peru, and the Dominican Republic.
“As the opioid crisis spreads from North America to other countries like Mexico, controlling the global opioid epidemic has become one of the health challenges of our decade,” Chamberland said.
“We have had discussions with numerous potential partners, but Alternavida had a clear interest in joining us in developing and bringing Caumz to market. Our relationship will grow over the years, and we look forward to working with this forward-thinking company as we join forces in Mexico,” he added.
The positive effects of cannabis and cannabis-derived substances to alleviate pain have been previously documented.
Positive results of a previous Phase 1 trial conducted in the United States and Canada have demonstrated that Caumz is generally safe and well-tolerated in healthy volunteers.
Interim analysis of the clinical data has provided a deeper understanding of the process of administering cannabinoids to patients, and may help health regulators decide the best strategies for treating patients with chronic pain.