US-based medical device company Cerus has entered into an agreement with the Biomedical Advanced Research and Development Authority (BARDA) in the US to support its clinical development programme for Intercept a pathogen reduction of red blood cell (RBC) components.
The Intercept Blood System is a pathogen reduction technology which is intended to reduce the risk of transfusion-transmitted infections by removing a broad range of pathogens such as viruses, bacteria, parasites, and leukocytes that may be present in donated blood.
The agreement will also allow Cerus access to funds amounting to $180m which are necessary to support studies for the US Food and Drug Administration (FDA) submission and assist in the marketing of the product.
Cerus chief scientific officer Dr Laurence Corash said: "This contract offers the potential to fund activities related to anticipated Phase III clinical studies for the Intercept Red Blood Cell System in the United States and the required manufacturing and development activities needed to pursue a potential US commercial launch.
"We believe that T-cell inactivation levels with INTERCEPT provide the opportunity for future replacement of gamma irradiation, which would also align with the Department of Homeland Security’s initiative to eliminate nuclear source irradiators in the US through the introduction of non-nuclear technologies."
A clinical trial conducted by Cerus to evaluate the safety and efficacy of INTERCEPT RBCs compared to conventional RBCs in Puerto Rico will be granted with an initial funding of up to $30.7m.
Pathogen reduction treatment of blood components paves the way for national emergency preparedness to combat epidemic and endemic blood-borne pathogens such as Zika, dengue, and chikungunya, and to immunise patients undergoing routine care, especially in regions under the risk of rapidly emerging epidemic pathogens.
Intercept pathogen reduction technology for platelets and plasma has seen its application in Europe for more than ten years to reduce the risk of transfusion-transmitted infections in platelet and plasma components, and was in routine use in French Polynesia and the French West Indies during the Zika outbreak in 2013-2014.