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Tetra Bio-Pharma Announces FDA Clearance on IND, allowing U.S. Reborn1(TM) Clinical Trial to Commence


OTTAWA, ON / ACCESSWIRE / January 29, 2021 / Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX:TBP) (OTCQB:TBPMF), a leader in cannabinoid-derived drug discovery and development announced today that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application, allowing Tetra to initiate its QIXLEEFTM Reborn1TM clinical trial in cancer patients with breakthrough pain.

"This is really good news for all of us and in particular for the cancer patients that suffer from breakthrough pain. We aim to initiate this proof-of-concept trial designed to demonstrate that QIXLEEF TM can provide pain relief faster than an immediate-release oral morphine," said Guy Chamberland, CEO and CRO of Tetra Bio-Pharma Inc.

Reborn1TM is a 10-week open-label randomized study to evaluate the effect of inhaled QIXLEEFTM 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).

The study's primary endpoint is the time weighted Sum of Pain Intensity Differences (SPID) from pre-dose to 30 minutes (SPID30) after the first inhalation or after taking MSIR. The SPID30 is based on a visual analog scale (VAS) score and is calculated for each BTcP episode that is treated with either study drug. The pain intensity is to be recorded by the patient in his/her diary. Secondary endpoints include difference in pain intensity and onset of pain relief at 5, 10, 15, 30 and 60 minutes, which will give insight to the timing of the onset of symptom relief for both treatments.

The study design includes a screening and titration period of up to 2 weeks followed by an open-label crossover comparison study where each patient will receive the investigational drug and active comparator for a 7-week treatment period, during which the groups will switch treatments at week 3.

The rationale to use inhaled QIXLEEFTM in cancer patients with BTcP is supported by a strong body of evidence demonstrating the fast onset of action of an inhaled drug and the pharmacological action of THC on the perception of pain (Ruiz M.E., Scioli Montoto S. (2018); Stockings E, Campbell G, Hall WD, et al (2018); Blanton HL, Brelsfoard J, DeTurk N, et al (2019).

About Tetra Bio-Pharma

Tetra Bio-Pharma (TSX:TBP) (OTCQB:TBPMF), is a biopharmaceutical leader in cannabinoid-based drug discovery and development with a FDA and a Health Canada approved 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:

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.:

Investor Contact:

Tetra Bio-Pharma Inc
Dr. Guy Chamberland, M.Sc., Ph.D.
Chief Executive Officer
Phone: + 1 (833) 977-7575

Alpha Bronze, LLC
Mr. Pascal Nigen
Phone: + 1 (646) 255-0433

Media Contact:

energi PR
Ms. Carol Levine APR, FCPRS
Phone: + 1 (416) 425-9143 ext. 226
Mobile: + 1 (514) 703-0256

SOURCE: Tetra Bio-Pharma

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