Tetra Bio-Pharma Announces Plenitude Clinical Trial is Initiated
Tetra Bio-Pharma has initiated the clinical trial operations for its investigational drug QIXLEEF™, aimed at alleviating pain in cancer patients. The Plenitude® trial has received all necessary authorizations from the FDA and DEA, and involves ten clinical sites across the US. This double-blind, placebo-controlled trial will enroll 78 patients and aims to demonstrate the safety and efficacy of inhaled QIXLEEF™. CEO Dr. Guy Chamberland expressed confidence in the trial's safety following recent data showing reduced CBD metabolite levels, addressing previous concerns about liver injury.
- The Plenitude® trial has received FDA and DEA authorization, enabling progress in clinical operations.
- The trial aims to prove QIXLEEF™'s efficacy and safety for pain relief in cancer patients, a significant market need.
- Recent data showing significantly lower CBD metabolites enhances confidence in the safety of QIXLEEF™, mitigating previous liver injury concerns.
- None.
Pharmaceutical GMP grade QIXLEEF™ shipped
OTTAWA, ON / ACCESSWIRE / September 2, 2020 / Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX:TBP) (OTCQB:TBPMF), a leader in cannabinoid-derived drug discovery and development, is pleased to announce that it has initiated the in-life phase of the clinical trial operations now that the investigational QIXLEEF™ drug has been shipped by Aphria Inc.
The Plenitude© trial is designed to prove the efficacy and safety of QIXLEEF™ for the relief of pain in cancer patients. This trial, and its clinical sites across the Unites States, have already received the authorizations from the US Food and Drug Administration (FDA) and the US Drug Enforcement Agency (DEA). Since the authorization from the US FDA in November 2019, Tetra has been working with Aphria Inc. to manufacture sufficient quantities of high quality pharmaceutical GMP grade QIXLEEF™ product according to upgraded specifications on drug product composition as approved by the FDA.
The Plenitude© trial involves ten clinical sites across the United States. Tetra is using a DEA-licensed centralized pharmacy to distribute QIXLEEF™ to the clinical sites and ensure random and double-blind allocation of the product to the patients in accordance with Good Clinical Practices and the USA Food and Drug regulations. With these critical pieces in place, patient recruitment, enrollment and treatment will now begin. Plenitude© is a 4-week double-blind, randomized, placebo-controlled, parallel group design trial to evaluate the safety and efficacy of inhaled QIXLEEF™ to relieve uncontrolled cancer related pain in 78 adult patients with advanced incurable disease.
Dr. Guy Chamberland, CEO and CRO commented, "last week we announced the significantly lower levels of CBD metabolites and today we are pleased to announce that QIXLEEF™ has been shipped by Aphria Inc. The Plenitude© trial has been anticipated for a long time and we are proud that the challenge of ensuring high quality pharmaceutical grade GMP product for patients with a plant-based drug has been overcome. Now, with last week's data, we are confident that we will not have any drug-related liver injury events in the trial. This is a major scientific milestone as it addresses the safety of vaporized QIXLEEF after the discouraging liver injury safety results observed in oral CBD trials for the treatment of seizures."
About Tetra Bio-Pharma
Tetra Bio-Pharma (TSX: TBP) (OTCQB: TBPMF), is a biopharmaceutical leader in cannabinoid-based drug discovery and development with a Health Canada approved, and FDA reviewed and approved, clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. The Company has several subsidiaries engaged in the development of an advanced and growing pipeline of Bio Pharmaceuticals, containing cannabinoid and other medicinal plant-based elements. 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 bio pharma industry by regulators, physicians and insurance companies.
For more information visit: www.tetrabiopharma.com
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture 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
investors@tetrabiopharma.com
Alpha Bronze, LLC
Mr. Pascal Nigen
Phone: + 1 (646) 255-0433
tetra@alphabronze.net
Media Contact:
energi PR
Ms. Carol Levine APR, FCPRS
Phone: + 1 (416) 425-9143 ext. 226Mobile: + 1 (514) 703-0256
carol.levine@energipr.com
SOURCE: Tetra Bio-Pharma
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FAQ
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