Tetra Bio-Pharma has secured a no objection letter (NOL) from the Therapeutic Products Directorate (TPD) Health Canada for a clinical trial application (CTA) to conduct a Phase lll clinical trial of PPP001 smokable dried cannabis prescription drug to treat terminally ill cancer patients.
The trial expects to enrol a total of 946 subjects to evaluate the therapeutic benefits of PPP001 in improving quality of life and treating pain in terminal cancer patients.
The trial will seek to address the potential of PPP001 to reduce the reliance on opioids for management of severe pain among those patients.
As part of the trial, Tetra also aims to collect the pharmaco-economics evidence required from insurers in order to support the reimbursement of the cannabis prescription drug.
Canada’s medical clinic and resource centre specialising in cannabis and cannabinoids for medical purposes, Santé Cannabis, will be the first and main recruitment centre for the trial.
Tetra Bio-Pharma chief scientific officer Dr Guy Chamberland said: "The development of PPP001 for patients with advanced cancer is an important commitment for Tetra, given that cancer patients suffer from severe pain which is often accompanied by depression and insomnia.
"Medical cannabis has been shown to help patients beyond the immediate benefit of pain relief."
In addition, Tetra signed a supply agreement with Canadian medical cannabis provider Aphria to use the latter’s unique blend of dried medical cannabis in its PPP001 clinical trial.