Cannabis
Tetra Bio-Pharma Announces Positive Initial Clinical Data from Both of its Ongoing Phase 2 Clinical Trials of QIXLEEF™
Tetra Bio-Pharma Inc. (“Tetra” or the “Company”) (TSX: TBP) (OTCQB: TBPMF) (FRA: JAM1), a leader in cannabinoid-derived drug discovery and development today announced positive initial clinical data from its ongoing Phase 2 clinical trials (REBORN©1 and PLENITUDE©) of QIXLEEF™ for cancer pain. QIXLEEF™ 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 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.
Safety data of the REBORN©1 trial collected up to now confirm QIXLEEF™ tolerability and good safety profile in patients with cancer with breakthrough pain; no serious adverse events have been reported, only adverse drug reactions of mild intensity have been recorded. Preliminary data of the PLENITUDE© trial also confirm QIXLEEF™ tolerability and good safety profile in the pool of subjects treated with either QIXLEEF™ or the placebo in the randomized double-blind 4-week period and in subjects treated with QIXLEEF™ during the open-label 11-month period. Preliminary analysis of the data shows a positive effect on pain relief in QIXLEEFTM-treated patients. The Company cannot disclose further data on efficacy due to regulatory compliance.
Dr. Guy Chamberland, CEO and CRO commented, “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. 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.”
Lastly, Tetra’s metabolite profile study in humans showed that intake of QIXLEEF™ does not lead to significant levels of metabolites associated with toxicity and its pharmacokinetic profile mirrors the temporal characteristics of breakthrough cancer pain episodes, with a transient and fast effect of action. Tetra’s Phase I trials showed that maximal plasma concentration was reached within 5 minutes and that the drug was well tolerated with a good safety profile.
-
Cannabis2 weeks ago
Mikra Announces Partnership with Virun NutraBiosciences Inc. and Releases CELLF 2.0
-
Cannabis2 weeks ago
IM Cannabis Reports First Quarter Financial Results
-
Innocan1 week ago
Innocan Pharma Reports Breakthrough in a Pre-Clinical Trial: Liposomal-CBD Injection Restores Mobility to an Amputee Female Donkey
-
Cannabis7 days ago
Avicanna Announces Results of Study in Patients with Epidermolysis Bullosa
-
Cannabis7 days ago
Global Legal Marijuana Strategic Business Report 2024: A $125+ Billion Market by 2030 Featuring Aphria, Aurora Cannabis, Beacon Medical, Canopy Growth, Cronos, OrganiGram, Tikun Olam, Tilray, Wayland
-
SCHWAZZE4 days ago
Schwazze Announces First Quarter 2024 Financial Results
-
Cannabis5 days ago
Polyethylene Films Packaging Market Size to Worth USD 139.98 Bn by 2032
-
Cannabis6 days ago
North America Legal Cannabis Industry Report 2024: Market to Grow at a CAGR of 26.65% During 2023-2032, Bank Loans Boosting Business Growth