The licensed anthrax vaccine, BioThrax(r), elicits protective immunity consisting of multiple antibodies that protect against anthrax. In purified form, these anthrax immune globulins can be administered to victims of inhalational anthrax to provide immediate protective immunity against drug-sensitive, and importantly, drug- resistant strains of B. anthracis. Proposed herein is the clinical development of Anthrax Immune Globulin for intravenous administration (AIGIV) for the intended indication of the """"""""Treatment of inhalational anthrax due to antibiotic-susceptible and antibiotic-resistant B. anthracis in persons 18-65 years of age."""""""" An additional indication will be sought for the prophylaxis of inhalational anthrax for individuals at risk for having contact with, or who have contacted, either antibiotic-resistant and/or antibiotic-susceptible B. anthracis (pre- exposure and post-exposure prophylaxis). Proposed herein is a single, dose-ranging, placebo-controlled clinical trial to test the tolerability and pharmacokinetics of AIGIV (anti-PA IgG and Toxin Neutralizing Activity, TNA). Outside the scope of this application Emergent ImmunoSolutions will manufacture and release one cGMP lot of AIGIV and conduct """"""""Animal Rule"""""""" efficacy studies in rabbit and NHP models. Emergent ImmunoSolutions has collected plasma from BioThrax(r)-immunized individuals for the manufacture of AIGIV using an FDA-approved process for immune globulin purification. The first clinical lot of AIGIV will be used for """"""""Animal Rule"""""""" studies to determine the doses providing preventative and therapeutic protection against aerosolized B. anthracis spore challenge. This information together with data from the proposed dose- ranging, safety and pharmacokinetic trial of AIGIV will be used to derive the human dose of AIGIV. The coupling of an FDA-approved anthrax vaccine to generate Source Plasma and an FDA-approved process for the production of AIGIV provides a low-risk path to the timely delivery of an efficacious, licensable anthrax therapeutic to fulfill the vital need to supply the Strategic National Stockpile. The targeting of multiple epitopes by polyclonal antibodies has potential advantages over a single monoclonal antibody for the treatment and prevention of inhalational anthrax. ? ? Emergent BioSolutions is a biologics company focused on the research, development and manufacture of novel vaccines and related products for prophylactic and therapeutic use against common diseases and biological weapons of mass destruction. Its subsidiaries are BioPort Corporation, the primary manufacturing operation, headquartered in Lansing, Michigan; research-focused Emergent ImmunoSolutions, located in Gaithersburg, Maryland; and research- focused Emergent Europe Limited, located in Reading, England. More information about Emergent BioSolutions and its subsidiaries can be found at www.ebsi.com. ? ? ?
