Emergent BioSolutions (EBS) IND for Anthrax Monoclonal Antibody Therapeutic Clears FDA Review
5/17/2010 9:33:38 AM
ROCKVILLE, Md.--(BUSINESS WIRE)--Emergent BioSolutions Inc. (NYSE:EBS) announced today that its Investigational New Drug (IND) application, to commence a Phase I clinical trial for its anthrax monoclonal antibody therapeutic, has cleared U.S. Food and Drug Administration (FDA) review. The Phase I study will evaluate the safety and pharmacokinetics of the company’s fully human monoclonal antibody being developed as a parenteral post-exposure therapy for individuals who have symptoms of anthrax disease. In pre-clinical therapeutic studies, Emergent’s monoclonal antibody was found to be effective.