Tetra Bio-Pharma's Management Provides Regulatory Update
Tetra Bio-Pharma's Management Provides Regulatory Update of ARDS-003 for the Potential Prevention and Treatment of Cytokine Release Syndrome OTTAWA, ON / ACCESSWIRE / June 17, 2020 / Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSXV:TBP)(OTCQB:TBPMF), a bio-pharmaceutical company engaged in cannabinoid-derived drug discovery and development, today provides an update on the development of its ARDS-003 intravenous drug product for the potential treatment of cytokine release syndrome (CRS) and the potential prevention of Acute Respiratory Distress Syndrome (ARDS) development in hospitalized patients with COVID-19. 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."