Cerus has entered an agreement with the Biomedical Advanced Research and Development Authority (BARDA) to support Cerus’ clinical development program for pathogen reduction of red blood cell (RBC) components, including access to funding that could support various activities, such as the funding of studies necessary to support an FDA submission and to accelerate commercial scale.
Cerus will receive initial funding of up to $30 million to support activities related to a clinical trial to assess the safety and efficacy of INTERCEPT™ RBCs compared to conventional RBCs in Puerto Rico, a region impacted by the current Zika virus epidemic. This funding also will support activities related to in vitro studies to facilitate potential pivotal Phase III clinical trials in the continental U.S.
Positive results have been reported from a European Phase III INTERCEPT RBC System clinical trial in January 2015, and also from a U.S. Phase II clinical trial in December 2014. The application submission for a CE Mark registration of INTERCEPT RBCs is planned for the second half of 2016.
The information on this site is not country-specific, and may contain information that is outside the approved indications for the country in which you are located. Use of INTERCEPT Plasma or Platelets is contraindicated in patients with a history or allergic response to amotosalen or psoralens. Consult instructions for use for indications, contraindications, warnings, and precautions.