FDA Accepts COVID-19 Clinical Study and Advises on Next Steps for Pre-IND Filing by Medolife Rx

BURBANK, Calif., June 23, 2021 (GLOBE NEWSWIRE) --  via NewMediaWire – Medolife Rx, Inc. ("Medolife"), a global integrated biopharmaceutical company with R&D, manufacturing, and consumer products, which is a majority owned subsidiary of Quanta, Inc. (OTC PINK: QNTA), announced today that the Company has received a response from the U.S. Food and Drug Administration (FDA) relating to its Pre-Investigational New Drug (Pre-IND) filing on its lead drug candidate Escozine for the treatment of the SARS-CoV-2 (COVID-19) virus. The response validated the Company’s clinical study conducted in the Dominican Republic (DR) and outlined next steps for its approval process in the US.

As the Company expected, it received a detailed response from the FDA on its Pre-IND originally filed on April 27, 2020. The response included: recognition from the FDA on the therapeutic effects of Escozine, validation of the Company’s clinical trial as an informal proof-of-concept study, and laid out very specific guidelines for the next steps required by the regulatory body in order to garner approval for Escozine as a treatment for COVID-19.

Subsequent to the acknowledgement of the trial, the FDA has requested that the Company complete two additional toxicology studies in animals. Since adoption of COVID-19 vaccinations, the FDA altered its protocol for measuring toxicology to include studying it at the DNA level. As this is a newer development, the agency has asked Medolife to provide data in this regard. Medolife has the product and protocol necessary to complete these studies in short-order.

“We could not be more pleased with the response from the FDA, in its acknowledgment of our clinical trials on Escozine and its potential therapeutic benefit, as well as the very clear guidelines set forth in the response for moving our program forward,” said Medolife CEO Dr. Arthur Mikaelian.

The acknowledgment by the FDA of the clinical trial conducted in the DR as a proof-of-concept for Escozine’s therapeutic potential as a COVID-19 therapeutic is an important aspect of the response.

“Given the ever-changing landscape of COVID-19, we are pleased that the FDA recognizes that our original proposed study was a proof-of-concept design under our original Pre-IND submission,” said Christina DiArcangelo, CEO and Founder of Affinity Bio Partners, a contracted clinical consultant for Medolife.

DiArcangelo has 24 years of experience in the global biotechnology, pharmaceutical, device, and nutraceutical industries and has worked on products that have received FDA approval on 25 pharmaceutical drugs.