Tetra Bio-Pharma Inc. (TBPMF, TBP.TO) announced positive initial clinical data from its ongoing Phase 2 clinical trials--REBORN1 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.
According to the company, safety data of the REBORN1 trial confirmed 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 confirmed 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 showed a positive effect on pain relief in QIXLEEF-treated patients.
Tetra noted that its 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 said that its 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.
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