Tetra Bio-Pharma Obtains Health Canada Approval for Renewal of its Veterinary Clinical Study
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) (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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For further information, please contact Tetra Bio-Pharma Inc.:
Investor Contact:
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. 226
Mobile: + 1 (514) 703-0256
carol.levine@energipr.com
SOURCE: Tetra Bio-Pharma
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