Tetra Bio-Pharma: Positive Clinical Data From Both Phase 2 Clinical Trials Of QIXLEEF For Cancer Pain

Tetra Bio-Pharma Inc. TBP TBPMF, a leader in cannabinoid-derived drug discovery and development announced on Monday that it produced positive initial clinical data from its ongoing Phase 2 clinical trials of QIXLEEF™ (REBORN©1 and PLENITUDE©), which is a botanical inhaled investigational new drug with a fixed ratio of THC and CBD, that meets USA cGMP regulatory requirements.

The REBORN©1 trial is a head-to-head, open-label, crossover phase 2 study against oral opioids in the management of short and frequent episodes of incapacitating pain (breakthrough pain) in patients with cancer. The REBORN©1 study protocol is assessing the safety and preliminary efficacy of QIXLEEF™ in the onset of pain relief and on pain intensity compared to three types of immediate-release oral opioids: oral morphine sulfate immediate release, oral hydromorphone immediate release, and oral oxycodone immediate release.

The PLENITUDE© trial is a randomized double-blind phase 2 study assessing the safety and efficacy of QIXLEEF™ in patients with cancer who have uncontrolled pain. Both studies are conducted across multiple clinical sites located in the United States, reported Tetra in a press release.

Preliminary analysis of the data shows a positive effect on pain relief in QIXLEEFTM-treated patients. Tetra Bio-Pharma, based in Ottawa, Canada, cannot disclose further data on efficacy due to regulatory compliance.

"A safe and efficient therapeutic alternative that allows the reduction of opioids is critical now more than ever to support patients in their journey against pain. Preliminary data from both REBORN©1 and PLENITUDE© confirm the safety and pharmacodynamic profile of QIXLEEF™ reported in the phase I trials," said Dr. Guy Chamberland, Tetra CEO and CRO. "The pharmacokinetic profile of QIXLEEF™ is well indicated to help manage short episodes of pain such as breakthrough pain and will offer patients and physicians a viable, safer, and non-opioid option for pain management."

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