Tetra Bio-Pharma Initiates Enrolment of Patients in Phase 3 PPP001 Smokable Cannabis Pellet Study
OTTAWA, ONTARIO–(Marketwired – April 4, 2018) - Tetra Bio-Pharma Inc. (“Tetra” or the “Company“) (TSX VENTURE:TBP) (OTCQB:TBPMF), today announced the initiation of screening and enrolment activities in the Phase 3 study of its PPP001 smokable cannabis pellet for advanced cancer patients with uncontrolled pain.
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% THC and 2.5% 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.”
On February 28th, 2018, Santé Cannabis received authorization from the Office of Controlled Substances to use PPP001 (controlled substance) for the Phase 3 clinical trial. This authorization granted the Principal Investigator of the Phase 3 trial, Dr. Antonio Vigano, exemption from the application of several provisions of the Controlled Drugs and Substances Act and the Narcotic Control Regulations thereby allowing the investigator to proceed with the clinical study of PPP001 in advanced cancer patients. In addition, the exemption allows Santé Cannabis to store and dispense the study medication directly to the patients, a process not permitted by Licensed Producers under the ACMPR.
“We are performing the first large study of the safety and efficacy of a dried cannabis smoked drug in advanced cancer patients,” added Guy Chamberland. “Over the next month Tetra will expand the trial by working with other clinics across Canada. Most importantly, we believe this multisite study has the potential to change the current vision of the use of smoked cannabis as an effective palliative care therapy of patients with advanced cancer.”
PPP001 aims to be the first smokable marihuana for advanced cancer pain 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% THC and 2.5% CBD.
About Tetra Bio-Pharma:
Tetra Bio-Pharma (TSX VENTURE:TBP) (OTCQB:TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and clinical development. Tetra is focusing on three core business pillars: clinical research, pharmaceutical promotion and retail commercialization of cannabinoid-based products.
More information at: www.tetrabiopharma.com
Source: Tetra Bio-Pharma
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Dr. Anne-Sophie Courtois, DVM
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