Cleveland BioLabs is continuing a project for the federal government that explores therapies for conditions resulting from acute radiation exposure.
The company announced April 29 that the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services has exercised the second and third milestone-based options on its $15.6 million, three-year contract with Cleveland BioLabs, awarded last fall.
The project deals with select tasks in the advanced development of Protectan CBLB502.
According to a prepared release, option two includes $1.47 million to support additional manufacturing and release of a new lot of CBLB502, as well as additional animal studies. Option three includes $460,000 to support additional good laboratory practice efficacy studies in non-human primates. All are activities necessary for completion of a biologic license application with the U.S. Food and Drug Administration (FDA).
The first milestone-based option was awarded in September for $6.3 million.
"BARDA's decision to exercise these milestone-based funding options under our development contract is further indication of the progress we have made in advancing CBLB502 towards submission for FDA licensure," said Michael Fonstein, CEO and president.
Protectan CBLB502 is a derivative of a microbial protein which has demonstrated the capacity to reduce injury from acute stresses, such as radiation and chemotherapy, in animal models. It is being developed under the FDA's animal efficacy rule to treat acute radiation syndrome (ARS) or radiation poisoning from exposure to radiation, such as a nuclear or radiological weapon/dirty bomb, or from nuclear accident.
There is currently no FDA approved medical countermeasure to treat ARS.