Earlier this month, the corporation submitted a meeting request to the FDA, along with an information package as part of the COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products. This PIND package contains Tetra’s proposed plan to investigate ARDS-003 in patients infected with COVID-19 and its registration strategy to bring this new drug into the market, should safety and efficacy be demonstrated. We will provide an update to the market as soon as we receive feedback from the FDA. Similarly, the corporation is also seeking guidance from Health Canada for its ARDS-003 proposed drug development program in the same patient population.
Tetra is preparing the regulatory file to initiate the filing of clinical trial applications in Canada and the USA. The corporation initiated several toxicology studies earlier this month. This includes microsome and hepatocyte stability studies, protein binding assays, intravenous compatibility, hERG assay for cardiovascular safety, single dose intravenous pharmacokinetic studies in rats and dogs, and reverse mutation and in vitro micronucleus assays for genotoxicity. During the next month, additional toxicology studies will be initiated in parallel as Tetra prepares the safety data package to support the administration of this experimental drug to patients with COVID-19.
In parallel to the toxicology program, the development, improvement, and optimization of the Active Pharmaceutical Ingredient (API) and finished product manufacturing processes as well as GMP compliance are moving to ensure readiness for a fast initiation of clinical studies.
Dr. Guy Chamberland, CEO & CRO of Tetra commented, “The Company is not making any express or implied claims that its product has the ability to eliminate, cure and/or contain the COVID-19 virus at this time. The nonclinical safety program is moving forward as planned by the drug development team. We have designed the nonclinical safety program to be able to initiate studies in both healthy volunteers and patients. This type of strategy provides Tetra with the most flexibility to rapidly initiate clinical trials as opportunities occur.”
About Tetra Bio-Pharma
Tetra Bio-Pharma (TSXV: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 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.:
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