Cytocom Gets FDA Clearance for Phase II Trial of COVID Immune Therapy

Cytocom, Inc., a biopharmaceutical company creating next-gen immune therapies, received clearance from the U.S. FDA for its IND application for a Phase 2 trial to evaluate the safety and efficacy of CYTO-205 as a treatment to slow or halt the progression of SARS-CoV-2, the virus that causes COVID-19. CYTO-205 is designed to modulate immune system function, decrease elevated inflammatory responses associated with viral infection and inhibit viral replication in human lung cells.

The trial will evaluate safety and efficacy of CYTO-205 in adult patients with mild COVID-19 infection who are at high risk for disease progression. Patient enrollment will begin during the 2Q21 at Loma Linda University Health in Loma Linda, CA.

"Even as new vaccines are introduced into the market and inoculation programs continue to expand, the need for safe and effective therapies to treat COVID-19 remains undiminished, especially in light of the spread of new, highly contagious variants of the virus," stated Michael Handley, President & CEO of Cytocom. "The early data regarding the potential of CYTO-205, as both an interventional therapy and a preventative agent is compelling, and we look forward to working with investigators at Loma Linda to further explore the possibilities."

Preclinical in vitro studies using coronavirus strain 229E and the pathological corona virus strain, SARS-CoV-2, have demonstrated the potential of CYTO-205 to inhibit the replication of corona viruses in human lung cells. Previously generated data also suggest that CYTO-205 could prevent the life-threatening lung inflammation caused by COVID-19, as well as lessen the risk of reinfection.