No adverse events observed in study participants
Health Canada VDD grants trial renewal
OTTAWA, ON / ACCESSWIRE / May 11, 2020 / Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSXV:TBP)(OTCQB:TBPMF) , a leader in cannabinoid-derived drug discovery and development, is pleased to announce that its pilot clinical study to evaluate the tolerability and potential efficacy of its PPP003 ophthalmic drug in the treatment of indolent corneal ulcers in companion animals has received its authorization by the Veterinary Drugs Directorate (VDD), Health Canada to continue. The VDD granted the renewal of the Experimental Studies Certificate (ESC) to the veterinary ophthalmologists that will be performing the clinical study for Panag Pharma (PANAG).
COVID-19 has significantly impacted the daily lives of Canadians. COVID-19 measures implemented by the New Brunswick provincial government were very effective in minimizing the spread of the virus. However, these measures did have minor consequences to corporations like Tetra. Completion of enrollment was planned by April 30, 2020 however, since these measures restricted the ability of owners to bring their pets to the veterinary clinic for trial procedures, this impacted Tetra's ability to complete enrolment as projected by May 1, 2020.
An ESC is granted for a period of one year under the veterinary drug regulations, therefore all study related activities, i.e. treatment and follow-ups, must be completed within that 1-year period. As a result of the COVID-19 enrolment halt, Tetra pro-actively submitted a renewal for the ESC to complete enrolment once COVID-19 restrictions are lifted and on April 30, 2020, the VDD granted the ESC for an additional year.
When enrolment halted due to COVID-19, 50% of the study subjects had completed the treatment and follow-up phase of the clinical trial. None of the study subjects had study medication-related adverse effects. The safety and tolerability profile of the PPP003 ocular drug product was part of the new ESC application for study renewal as well as new data regarding the sterility. With the New Brunswick government beginning to lift some of the preventive measures, enrolment will re-initiate and treatment of the remaining 50% of the subjects will begin once veterinary clinics are open to the public.
"As a health care corporation, Tetra fully supports the measures taken by governments to protect its citizens. These measures had only a minor impact on the PPP003 ophthalmic operations compared to the significant public health benefit. We are glad that the participants and support staff involved in the trial are healthy and safe and that we can now initiate re-activation of the trial." said Dr. Guy Chamberland, CEO and CRO of Tetra Bio-Pharma.
Dr. Chamberland also commented, "The eye formulation used in this trial use the same active pharmaceutical ingredient (API)/new chemical entity (NCE) concurrently being developed for managing cytokine release syndrome (CRS). However, the current finished drug formulation under evaluation in companion animals is completely different as this experimental medication is intended to be used as an eye drop. The NCE is a specific synthetic-derived CB2 agonist. PANAG's experimental studies demonstrated the ability of this NCE to reduce anti-inflammatory cytokines as well as decrease leukocyte-adhesion in acute and chronic eye conditions. This body of peer reviewed scientific research clearly shows the evidence-based rationale why Tetra is actively targeting acute and chronic inflammatory conditions."
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 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, 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 any 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.:
Alpha Bronze, LLC
Mr. Pascal Nigen
Phone: + 1 (646) 255-0433
Ms. Carol Levine APR, FCPRS
Phone: + 1 (416) 425-9143 ext. 226
Mobile: + 1 (514) 703-0256
SOURCE: Tetra Bio-Pharma