Direct Biologics begins phase II trial for COVID-19 ExoFlo therapy

By The Science Advisory Board staff writers

July 30, 2020 -- Regenerative medical products manufacturer Direct Biologics has won approval from the U.S. Food and Drug Administration to study its ExoFlo therapy in a clinical trial with COVID-19 patients.

ExoFlo is an investigational drug that uses extracellular vesicles derived from bone marrow to help modulate inflammation and potentially stimulate cellular communication. The ExoFlo Infusion Treatment for COVID-19 (EXIT COVID-19) Trial will test the product's ability to improve moderate to severe acute respiratory distress syndrome (ARDS) in 60 patients with the novel coronavirus disease.

The multicenter, double-blind clinical trial is believed to be the first to use bone marrow-derived extracellular vesicles to treat ARDS in COVID-19 patients, the company noted. It will investigate whether ExoFlo alters patients' days to recovery and mortality rates.

The EXIT COVID-19 trial builds upon a previous phase II study on the safety and efficacy of ExoFlo. The first trial enrolled 24 critically ill patients with COVID-19 and produced promising safety and efficacy data, according to Direct Biologics.

Inovio reports long-term positive results for COVID-19 vaccine
Inovio released results of a nonhuman primate study for its COVID-19 DNA vaccine, INO-4800. The vaccine protected the animals 13 weeks after vaccinations...
Inhibiting SARS-CoV-2 papain-like protease may stop viral spread
Another nonstructural protein, papain-like protease, has been identified as a SARS-CoV-2 therapeutic target with the potential to block viral replication,...
J&J reports positive preclinical results for COVID-19 vaccine
Johnson & Johnson reported that its lead COVID-19 vaccine candidate protected against SARS-CoV-2 in preclinical studies.
Animal study turns in positive results for Moderna-NIH COVID-19 vaccine
Moderna's COVID-19 vaccine candidate, messenger RNA (mRNA)-1273, has been shown to induce immune responses and control upper and lower respiratory tract...
ASU, World Economic Forum launch business survey for COVID-19
Arizona State University (ASU) and the World Economic Forum have launched COVID-19 Diagnostics Commons, a project that will survey businesses and share...

Copyright © 2020

Cell Bio 2021
December 11-15
San Diego, California United States
Antibody Engineering and Therapeutics
December 13-17
San Diego, California United States
Science Advisory Board on LinkedIn
Science Advisory Board on Facebook
Science Advisory Board on Twitter