ROCKVILLE, Md. — Emergent BioSolutions Inc. announced March 17, 2009, that the Phase I/II clinical trial for its anthrax immune globulin (AIG) therapeutic candidate has commenced with the initial treatment given to the first subject.
AIG, which is intended for the treatment of inhalational anthrax disease, is the company’s polyclonal therapeutic candidate developed using plasma collected from healthy donors who have been vaccinated with Emergent’s BioThrax (Anthrax Vaccine Adsorbed). BioThrax is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax infection.
“The initiation of this clinical trial is a significant milestone that marks our continued commitment to the AIG program and to the expansion of our anthrax product franchise,” said Dr. Stephen Lockhart, senior vice president product development of Emergent BioSolutions. “AIG is an integral component of our efforts to develop safe and effective treatments for patients to be used in the event of a biological attack.”
The clinical trial will evaluate the safety and pharmacokinetics of AIG in 120 healthy adult volunteers. The study is designed to evaluate three dose levels of a single intravenous infusion of AIG compared to Gamunex, a licensed immune globulin therapy for people with primary immunodeficiency or idiopathic thrombocytopenic purpura. AIG is manufactured using the FDA-approved Gamunex process. In addition, a fourth cohort receiving two intravenous infusions of AIG or Gamunex at equivalent doses administered two days apart will be evaluated.
The clinical trial will be conducted at SNBL Clinical Pharmacology Center in Baltimore. This project has been funded in whole or in part with federal funds from the Biomedical Advanced Research and Development Authority in conjunction with the National Institute of Allergy and Infectious Diseases.