Tetra Bio-Pharma (TSXV:TBP; OTCQB:TBPMF) announced the start of screening and enrollment for its phase 3 study of the PPP001 smokable cannabis pellet for advanced cancer patients with uncontrolled pain.
As quoted in the press release:
Tetra authorized the initiation of the patient enrolment activities at its main clinical site, Santé Cannabis, a private medical cannabis clinic in Montreal which is in compliance with Health Canada Division 5 regulations and the International Conference on Harmonization (ICH) Good Clinical Practices (GCP) (E6) R2.
PPP001 aims to be the first smokable cannabis for advanced cancer pain available under prescription. It is a dried cannabis pellet designed to be smoked in an inhalation device specifically developed for this product. PPP001 is a unique blend of 3 strains of standardized dried cannabis, creating a drug substance with 9.5 [percent] THC and 2.5 [percent] CBD.
“This is a significant milestone in the lead product of our strong pipeline of cannabinoid-based drugs targeting patients with advanced pain,” said Guy Chamberland, Tetra’s CEO and CSO. “The launch of the Phase 3 clinical trial will be used to support the marketing application of PPP001 smokable pellet that is followed by four other cannabinoid-based products that we are developing using different delivery systems such as oral tablets, eye drops, topical ointments and oral capsules of cannabis oil.”