Tetra Bio-Pharma Accelerates REBORN1 Trial
OTTAWA, ON, July 12, 2021 /PRNewswire/ - Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX: TBP) (OTCQB: TBPMF) (FRA: JAM1), a leader in cannabinoid-derived drug discovery and development announced today that the Central Ethics Committee has approved the proposed protocol modifications allowing additional immediate release oral opioids to be used as comparators in the REBORN1© study. Expanding to three (3) immediate release oral opioids will allow for the acceleration of patient enrolment in the REBORN1© trial.
The REBORN1© trial is a head-to-head phase 2 study against an opioid treatment in the management of short and frequent episodes of incapacitating pain (breakthrough pain) requesting immediate release opioid treatment in patients living with cancer. The initial protocol was assessing a direct safety and efficacy comparison between QIXLEEF™ and oral morphine sulfate immediate release on the onset of pain relief in this population. The approved amended protocol opens the recruitment to cancer patients with breakthrough pain who are treated with either oral morphine sulfate immediate release, oral hydromorphone immediate release, or oral oxycodone immediate release. This amendment will allow the Company to demonstrate the potential efficacy of QIXLEEF™ against a class of immediate relief oral opioids. Well-designed clinical evidence is required to demonstrate to physicians that QIXLEEF™ can be an alternative to the class of immediate release oral opioids. The amended protocol will be implemented at the clinical site upon approval of the Drug Enforcement Administration (DEA) and amendment of the study-specific Schedule I license.
QIXLEEF™ is the Company's inhaled proprietary drug formulation which has a fixed ratio of THC and CBD. The medication is inhaled through a Class II 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.
Dr. Guy Chamberland, CEO and CRO commented, "The amended protocol allows QIXLEEF™ to be studied against three types of immediate release oral opioids instead of just one. It will facilitate the recruitment of patients who can benefit from QIXLEEF™ to treat their breakthrough pain as it broadens the pool of qualified patients. Once the Schedule I license is approved, a process that usually takes a couple of weeks, the amended protocol will enhance the recruitment rate, thereby accelerating the study conduct. The approval by the DEA is a formality as the amendment does not modify the amount of controlled substance at the clinical site. Further, there have been numerous news reports recently of drug makers exiting the opioid business, however for patients suffering from uncontrolled pain, this news does not provide them with an alternative to alleviate their pain. Tetra is in the business of providing the evidence which would see QIXLEEF™ become an alternative prescription therapy to opioids".
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SOURCE Tetra Bio-Pharma Inc.
Company Codes: Frankfurt:JAM1, OTC-QB:TBPMF, Toronto:TBP