Cerus Corporation (NSDQ:CERS) said today that it exercised $10.8 million in additional options from its contract with the Biomedical Advanced Research & Development Authority, a part of the U.S. Dept. of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response. The funds will go towards in vitro pathogen inactivation and red blood cell function studies in support of FDA licensure and manufacturing clinical trial materials for a phase III trial in the U.S.
Concord, Calif.-based Cerus is developing the Intercept blood system, a pathogen reduction device designed to inactivate a broad range of viruses, bacteria, parasites and leukocytes in donated blood.
“The exercise of these additional options reflects the substantial progress our team has made in just a few short months since initiating activities related to this important contract with BARDA,” chief scientific officer Dr. Laurence Corash said in prepared remarks. “We are working closely with the FDA to reach an agreement on the protocol design for our Phase III trial, and this additional funding ensures that we can begin preparing the necessary clinical trials materials to move forward quickly upon such agreement.”
The Intercept system has been used in Europe for over 10 years to inactivate pathogens in platelet and plasma components. Cerus also won FDA approvals for use of the Intercept system with platelets and plasma in 2014.
Last year, Cerus said its European phase III trial evaluating the Intercept system for red blood cells demonstrated positive results. The company said today that its plans to submit an application for CE Mark approval has been delayed, but that its European red cell study in chronic anemia has finished enrolling patients.
The Sparc trial, which is evaluating the Intercept system in patients with thalassemia major requiring chronic red blood cell transfusions, has enrolled its target 70 patients. Cerus said it anticipates the data from the Sparc trial will be available in time to support its expected product launch in Europe.
“Chronic anemia patients such as those with thalassemia major and sickle cell disease require more blood transfusions than almost any other patient group, putting them at elevated lifetime risk for exposure to existing and emerging pathogens,” chief medical officer Richard Benjamin said. “Our ability to provide safety and efficacy data generated by the chronic anemia study at the time of our anticipated product launch will be an important supplement to the clinical data already included for submission.”