Tetra Bio-Pharma Provides an Update on its U.S. REBORN1 Clinical Trial

Rhea-AI Summary

Tetra Bio-Pharma Inc. has announced the completion of manufacturing its investigational drug QIXLEEF for the REBORN1 clinical trial aimed at evaluating cannabis as an alternative to morphine for treating breakthrough cancer pain (BTcP). The company received an export permit from Health Canada allowing the shipment of QIXLEEF to the USA. The 10-week open-label study seeks to assess whether inhaled QIXLEEF offers faster pain relief than morphine sulfate immediate release. The trial is part of Tetra's commitment to addressing the opioid crisis.

Positive

• Successful manufacturing completion of QIXLEEF for the REBORN1 trial.
• Received export permit from Health Canada for shipping to the USA.
• Clinical trial REBORN1 aims to address the opioid crisis by evaluating cannabis as an alternative pain management option.

Negative

• None.

• First clinical study to assess cannabis as an alternative to morphine
• Tetra completes manufacturing of QIXLEEF clinical trial drug for REBORN1 trial
• Export permit received from Health Canada for immediate shipping to USA

OTTAWA, ON / ACCESSWIRE / April 23, 2021 / Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX:TBP)(OTCQB:TBPMF)(FRA:JAM1), a leader in cannabinoid-derived drug discovery and development is pleased to announce that it has shipped the investigational new drug, QIXLEEF, to the USA for the initiation of the REBORN1 study. The Company has completed the manufacturing of QIXLEEF and has received the cannabis export permit from Health Canada. REBORN1 will investigate cannabis as an alternative to morphine sulfate immediate release in the management of breakthrough pain. QIXLEEF is a botanical drug product with a "fixed ratio" of THC and CBD and is inhaled through a vaporizer.

"We are committed to the fight against the opioid crisis. That is why since the authorization of the clinical trial by the FDA in late January 2021, Tetra has worked hard to prepare QIXLEEF for clinical testing. We are on track to initiate this Phase 2 proof-of-concept trial designed to demonstrate that QIXLEEF can provide pain relief faster than an immediate-release oral morphine." said Dr. Guy Chamberland, CEO and CRO of Tetra Bio-Pharma Inc.

REBORN1 is a 10-week open-label randomized study to evaluate the effect of inhaled QIXLEEF compared to morphine sulfate immediate release (MSIR) to improve fast onset of pain relief of breakthrough cancer pain (BTcP). BTcP is a rapid onset, high intensity, and short duration pain episode, which takes place within stable background pain control. The time to peak intensity of an episode ranges from 3 to 15 minutes with a duration of 30 to 60 minutes. They occur with a frequency of 1.5 to 6 times per day and the majority are moderate to severe in intensity (Portenoy and Hagen 1990; Portenoy et al. 1999; Davies et al. 2011). It significantly affects the quality of life of patients with cancer and their ability to function normally (Zeppetella and Davies 2013).

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. Our evidence-based scientific approach has enabled us 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 we 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.

For further information, please contact Tetra Bio-Pharma Inc.:

Tetra Bio-Pharma Inc.
Ms. Natalie Leroux

Phone: + 1 (833) 977-7575
Email: investors@tetrabiopharma.com
media@tetrabiopharma.com

SOURCE: Tetra Bio-Pharma

View source version on accesswire.com:
https://www.accesswire.com/641918/Tetra-Bio-Pharma-Provides-an-Update-on-its-US-REBORN1-Clinical-Trial

FAQ

What is the purpose of the REBORN1 clinical trial involving TBPMF?

The REBORN1 clinical trial aims to evaluate QIXLEEF as an alternative to morphine for managing breakthrough cancer pain.

When did Tetra Bio-Pharma receive the export permit for QIXLEEF?

Tetra Bio-Pharma received the export permit from Health Canada prior to initiating the REBORN1 study.

How does QIXLEEF compare to morphine according to the trial?

The trial will assess whether inhaled QIXLEEF provides faster pain relief compared to morphine sulfate immediate release.

What is the expected duration of the REBORN1 study?

The REBORN1 study is designed as a 10-week open-label trial.