CytoSorbents said today it has been awarded a 2-year, roughly $1 million Small Business Innovation Research (SBIR) Phase II contract to further the development of its flagship product CytoSorb® as a medical countermeasure for fungal mycotoxin blood purification.

CytoSorb is an extracorporeal cytokine adsorber, designed to reduce the “cytokine storm” or “cytokine release syndrome” that could otherwise cause massive inflammation, organ failure, and death in common critical illnesses, such as sepsis, burn injury, trauma, lung injury, and pancreatitis, as well as in cancer immunotherapy. 

The Phase II SBIR contract follows successful completion of a $150,000 Phase I SBIR contract for mycotoxin removal.

“In the Phase I SBIR program, we demonstrated the rapid and robust reduction of aflatoxin and T-2 mycotoxin from whole blood in vitro,” Thomas D. Golobish, Ph.D., co-principal investigator and senior director of polymer development at CytoSorbents, said in a statement. “Coupled with the ability of CytoSorb to reduce a broad range of pathogenic toxins and inflammatory mediators, such as cytokines from blood, as well as toxins such as bilirubin that can accumulate in acute liver failure, we believe CytoSorb may have a synergistic benefit in mycotoxin exposure and fungal sepsis.”

In Phase II, CytoSorbents said, it will focus on demonstrating the ability of CytoSorb to adsorb mycotoxins in vivo and improve survival in animals.

The Phase II contract is funded through the Chemical and Biological Defense (CBD) SBIR Program, part of the Joint Chemical and Biological Defense Science & Technology Program.  The SBIR project is being managed by the Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD), the U.S. Department of Defense focal point for research, development, acquisition, fielding, & life-cycle support of Chemical, Biological, Radiological, Nuclear (CBRN) equipment and medical countermeasures.

“If successful, this could represent a significant advance in the protection of our troops and civilians against these deadly toxins,” added CytoSorbents CEO Phillip P. Chan, M.D., Ph.D.

The Phase II program, if successful, would also provide key data supporting the use of CytoSorb to help treat fungal infections. They account for approximately a quarter of all hospital-acquired infections, which are extremely difficult to treat and where death is common, Dr. Chan added.

CytoSorbents' advanced development program—titled “Mycotoxin Adsorption with Hemocompatible Porous Polymer Beads”—is funded under JPEO-CBD contract number W911QY-17-C-0007.

Approved in the European Union with distribution in 43 countries worldwide, CytoSorb is designed to counteract accidental or intentional exposure to mycotoxins, such as aflatoxin and T-2 toxin. CytoSorb is also being used during and after cardiac surgery to remove inflammatory mediators, such as cytokines and free hemoglobin, which can lead to post-operative complications, including multiple organ failure.

To support a future FDA application for CytoSorb’s use in cardiac surgery, CytoSorbents plans to initiate a pivotal REFRESH (REduction in FREe Hemoglobin) 2 trial later this year. The company has completed a Phase I REFRESH 1 trial, a multicenter, randomized controlled study that has demonstrated the safety of intraoperative CytoSorb use in a heart-lung machine during complex cardiac surgery.