Tetra Bio-Pharma Inc (TSX:TBP) (OTCQB:TBPMF) (FRA:JAM1) said it is speeding up its “revolutionary” Phase 2 clinical trial, PLENITUDE, to evaluate the safety and effectiveness of its investigational cannabis medicine QIXLEEF, for use in managing uncontrolled pain in patients with advanced cancer.
The Ottawa, Ontario-based company's inhaled proprietary drug formulation QIXLEEF has a fixed ratio of THC and CBD. The medication is inhaled through a Class 2 medical vaporizer. When pharmaceutical-grade cannabis is vaporized rather than smoked, the beneficial components can be inhaled without the generation of smoke and combusted by-products, said the company.
In a statement, Tetra Bio-Pharma CEO Dr Guy Chamberland said: "The PLENITUDE study has been underway for many months and we are now accelerating its enrollment activities. Tetra currently has two Phase 2 clinical trials ongoing in the United States. Though both trials, PLENITUDE and REBORN1, will evaluate QIXLEEF, each has a very different objective.”
READ: Tetra Bio-Pharma announces start of REBORN1 clinical trial using QIXLEEF to treat cancer pain
“The PLENITUDE trial will assess how QIXLEEF may manage uncontrolled cancer pain in patients living with advanced cancer and the REBORN1 trial is a head-to-head study against an opioid treatment in the management of short and frequent episodes of incapacitating pain requesting immediate-release opioid treatment in cancer patients.”
Dr Guy Chamberland said he believed that based on “our years of research” QIXLEEF will be proven to be safe and effective, and if so, provide patients with cancer pain “a safer treatment option with potentially greater benefits than the current standard of care."
The PLENITUDE trial is a four-week randomized, double-blind, placebo-controlled study and has been reviewed by an ethics committee. Patients will receive four weeks of either the study treatment or a placebo, after which all patients will be eligible to receive the active study drug for up to an additional 48 weeks. “Pain levels will be measured throughout the course of the study to determine the efficacy of the study medication,” noted the company.
"The goal of the PLENITUDE study is to help patients with advanced cancer manage their pain to improve their overall quality of life. I am excited about this study because it offers hope to patients who experience severe pain,” said medical expert Dr Sue Sisley, who is the principal investigator.
“Many patients have difficulty tolerating powerful therapies, like opioids. I am encouraged because cannabis has been long considered a low-risk option for patients with cancer with few and tolerable side effects. Together we may discover a new treatment option for managing pain," she added.
Market studies on behalf of Tetra for advanced cancer pain in the US compute the addressable market at over $900 million by 2030. The figure takes into consideration the off-label market, which will continue to demand non-opioid treatments, said the company.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
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