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Tetra Bio-Pharma Announces Positive Initial Clinical Data from Both of its Ongoing Phase 2 Clinical Trials of QIXLEEF™
Tetra Bio-Pharma Announces Positive Initial Clinical Data from Both of its Ongoing Phase 2 Clinical Trials of QIXLEEF™.
About this update from Tetra Bio-pharma Inc.
[{"type":"text","content":"\n\n\n\nTetra Bio-Pharma Announces Positive Initial Clinical Data from Both of its Ongoing Phase 2 Clinical Trials of QIXLEEF™\n\n/* Style Definitions */\nspan.prnews_span\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\na.prnews_a\n{\ncolor:blue;\n}\nli.prnews_li\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\np.prnews_p\n{\nfont-size:0.62em;\nfont-family:\"Arial\";\ncolor:black;\nmargin:0in;\n}\n\n\n\n\n\n\nTetra Bio-Pharma Announces Positive Initial Clinical Data from Both of its Ongoing Phase 2 Clinical Trials of QIXLEEF™\nPR Newswire\nOTTAWA, ON, Nov. 29, 2021\n\n\n\nOTTAWA, ON, Nov. 29, 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 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.\n\n \n \n \n \n \n \n\n \nThe 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.\nSafety 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 subje...