Cerus (NSDQ:CERS) landed a $15 million amendment to its contract with the U.S. Dept. of Health & Human Services’ Biomedical Advanced Research and Development Authority, bringing the total potential value of its deal to $201 million.
The expanded agreement is designed to support additional clinical trials of the company’s Intercept blood transfusion technology.
Cerus’ Phase III ReCePI study is slated to assess the safety and efficacy of Intercept-treated red blood cells in patients requiring transfusion for acute blood loss during complex cardiac surgery. The 600-patient trial will randomize participants to receive either conventional red blood cells or those treated with Cerus’ Intercept technology, which inactivates an array of pathogens in an attempt to reduce the risk of transfusion-transmitted infections.
The primary efficacy endpoint of the ReCePI study is the proportion of patients with acute kidney injury within 48 hours following surgery.
The Phase II SCient trial will study the efficacy and safety of Intercept-treated red blood cells in sickle cell disease patients undergoing exchange transfusion, according to Cerus.
“BARDA is an important partner in our mission to establish Intercept as the standard of care for all transfused blood components globally,” chief medical officer Richard Benjamin said in prepared remarks.
“Our collaboration with BARDA provides Cerus with the support and non-dilutive funding anticipated to complete the clinical development, regulatory submission, and commercial scale-up activities for Intercept red blood cells in the U.S.,” he added.