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29.11.2021 12:30

Tetra Bio-Pharma Announces Positive Initial Clinical Data from Both of its Ongoing Phase 2 Clinical Trials of QIXLEEF™

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OTTAWA, 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.

Tetra Bio-Pharma Inc. Logo (CNW Group/Tetra Bio-Pharma Inc.)

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.

About Breakthrough Cancer Pain

Opioids are the cornerstone of the management of cancer pain. The opioid crisis is serious, and the number of deaths related to overdosing remains elevated (Opioid Basics | CDC's Response to the Opioid Overdose Epidemic | CDC). Tetra's cannabis and cannabinoid-derived product pipeline has the potential to play a significant role in opioid use reduction, thus addressing a societal issue of critical proportion.

Current opioids approach to manage breakthrough pain are inadequate to timely relieve pain in patients with cancer. Immediate-release oral morphine produces an analgesic effect in 30-45 minutes, with peak effect at ~1 hour or more (Staahl C. et al., Journal of Clinical Pharmacology, 2008; 48:619-631), in contrast to episodes of breakthrough cancer pain, which typically peak within 3-15 minutes and last ~1 hour. In addition to inappropriate time window of efficacy, immediate-release oral opioids affect the patient's functioning (e.g., confusion) and quality of life (e.g., constipation, drowsiness, sleep disorders) and may induce life-threatening side effects such as respiratory depression in addition to multiple side effects. More potent opioids such as fast-onset opioids have a higher risk of abuse potential, increasing the risk of misuse and overdose. There is currently no therapeutic solution that offers fast onset of pain relief with an acceptable safety profile and low risk of abuse potential.

About Tetra Bio-Pharma

Tetra Bio-Pharma (TSX: TBP) (OTCQB: TBPMF) (FRA:JAM1) is a leader in cannabinoid-derived drug discovery and development with a FDA and a Health Canada cleared clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. Their evidence-based scientific approach has enabled them to develop a pipeline of cannabinoid-based drug products for a range of medical conditions, including pain, inflammation, and oncology. With patients at the core of what they do, Tetra Bio-Pharma is focused on providing rigorous scientific validation and safety data required for inclusion into the existing biopharma industry by regulators, physicians and insurance companies.

For more information visit: www.tetrabiopharma.com

Neither the TSX Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Exchange) accepts responsibility for the adequacy or accuracy of this release.

Forward-looking statements

Some statements in this release may contain forward-looking information. All statements, other than of historical fact, that address activities, events or developments that the Company believes, expects or anticipates will or may occur in the future (including, without limitation, statements regarding potential acquisitions and financings) are forward-looking statements. Forward-looking statements are generally identifiable by use of the words "may", "will", "should", "continue", "expect", "anticipate", "estimate", "believe", "intend", "plan" or "project" or the negative of these words or other variations on these words or comparable terminology. Forward-looking statements are subject to a number of risks and uncertainties, many of which are beyond the Company's ability to control or predict, that may cause the actual results of the Company to differ materially from those discussed in the forward-looking statements. Factors that could cause actual results or events to differ materially from current expectations include, among other things, without limitation, the inability of the Company to obtain sufficient financing to execute the Company's business plan; competition; regulation and anticipated and unanticipated costs and delays, the success of the Company's research and development strategies, including the success of this product  or any other product, the applicability of the discoveries made therein, the successful and timely completion and uncertainties related to the regulatory process, the timing of clinical trials, the timing and outcomes of regulatory or intellectual property decisions and other risks disclosed in the Company's public disclosure record on file with the relevant securities regulatory authorities. Although the Company has attempted to identify important factors that could cause actual results or events to differ materially from those described in forward-looking statements, there may be other factors that cause results or events not to be as anticipated, estimated or intended. Readers should not place undue reliance on forward-looking statements. The forward-looking statements included in this news release are made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities legislation.

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/tetra-bio-pharma-announces-positive-initial-clinical-data-from-both-of-its-ongoing-phase-2-clinical-trials-of-qixleef-301432639.html

SOURCE Tetra Bio-Pharma Inc.

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