The expansion to 20 clinical trial sites in Canada and the US will accelerate the SERENITY© study
OTTAWA, April 09, 2019 (GLOBE NEWSWIRE) — Tetra Bio-Pharma Inc. (“Tetra” or the “Company“) (TSX-V: TBP) (OTCQB: TBPMF), today announced it is ready to resume its Phase 3 clinical program in advanced cancer pain patients with the objective to assess Health- Related Quality of Life (HrQoL).
The SERENITY© Study will use a vaporizer, a Health Canada approved Class 2 medical device as a delivery mechanism which is more acceptable to hospitals and palliative care centers. Tetra’s new drug formerly referred to as PPP-001 will be investigated in the SERENITY © Study under the commercial trademark of CAUMZ. In preparation for commercialization, Tetra has decided to brand its investigational drug name for regulatory filing purposes.
In addition, the significant expansion of clinical trial sites to 20 in both Canada and the United States, will accelerate patient recruitment and help expedite Tetra’s submission to regulatory agencies.
“I am extremely pleased with Tetra’s ability to quickly resolve the problem that required us to suspend our clinical trial in advanced cancer pain. With great challenge comes great opportunity and what we are now able to deliver is a better and more reliable product,” said Dr. Guy Chamberland, CEO and CSO of Tetra Bio-Pharma. “The continuation of our research is excellent news, not only for those suffering with advanced cancer pain and other symptoms but also for our investors. I look forward to the day when Tetra’s cannabinoid-derived drugs will help reduce, if not eliminate the reliance on drugs like Fentanyl®, Oxycodone® or morphine and that hopefully the study drug will be able to bring serenity to patients in their difficult journey through the disease.”
About Tetra Bio-Pharma:
Tetra Bio-Pharma (TSX-V: TBP) (OTCQB: TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and development with a Health Canada authorized, and FDA reviewed, clinical trials 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, Natural Health and Veterinary Products containing cannabis 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
Source: Tetra Bio-Pharma
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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 CAUMZ and its other drug candidates, the applicability of the discoveries made therein, the successful and timely completion and uncertainties related to the regulatory process including the applications for Orphan Drug Designation, 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.
Tetra Bio-Pharma Contact:
Sr VP Marketing and Medical Affairs
Pierre Boucher, CPA, CMA
Partner, Executive Vice-President
514-731-0000 ext. 237
Media Contact :
Carol Levine, APR, FCPRS
CEO 514-288-8500 ext. 226
Source: Tetra Bio-Pharma Inc