Elusys Therapeutics is actively developing a novel, ultra high-affinity monoclonal antibody (Mab) to neutralize the lethal effects of anthrax toxin. Elusys's Mab, ETI-204, is directed against Protective Antigen (PA) of B. anthracis and is being developed for both prophylactic and therapeutic treatment of anthrax infections resulting from a bioterrorist attack. Anthrax is currently considered by the federal government to be the number one biowarfare threat. In both mouse and rabbit studies, ETI-204 has protected 100% of treated animals from death following exposure to anthrax toxin or inhaled spores. As a result of this compelling data, the Company is rapidly pursuing a well defined clinical development program with input from meetings with both the Office of Counterterrorism (OCTAP) and the FDA. This application is for funding to complete the final animal efficacy testing, human safety testing and pharmaceutical manufacturing necessary to apply for FDA approval of ETI-204 for treatment of anthrax infection in both pre- and post exposure situations.
The specific aims of this application are: (1) to develop a scaleable ETI-204 manufacturing process; (2) to complete definitive efficacy testing in a primate spore challenge model: (3) to produce clinical-grade ETI- 204; and (4) to complete human safety trials. Due to the urgent national need for an effective anthrax therapeutic, Elusys, with funding from DoD, has already initiated and will have completed several additional animal efficacy and PK studies to further ensure the success of ETI-204's continued development as outlined in this application. Funding provided under this application would greatly facilitate and expedite the final development work necessary to validate the safety and efficacy of a much needed anthrax antidote to protect both military and civilian personnel.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
NIH Challenge Grants and Partnerships Program - Phase II-Coop.Agreement (UC1)
Project #
1UC1AI062546-01
Application #
6845421
Study Section
Special Emphasis Panel (ZAI1-TH-M (M1))
Program Officer
Zou, Lanling
Project Start
2004-09-30
Project End
2007-08-31
Budget Start
2004-09-30
Budget End
2007-08-31
Support Year
1
Fiscal Year
2004
Total Cost
$5,000,000
Indirect Cost
Name
Elusys Therapeutics, Inc.
Department
Type
DUNS #
083819511
City
Pine Brook
State
NJ
Country
United States
Zip Code
07058
Tartaglione, T A; Collier, A C; Opheim, K et al. (1991) Pharmacokinetic evaluations of low- and high-dose zidovudine plus high-dose acyclovir in patients with symptomatic human immunodeficiency virus infection. Antimicrob Agents Chemother 35:2225-31
Tartaglione, T A; Collier, A C; Coombs, R W et al. (1991) Acquired immunodeficiency syndrome. Cerebrospinal fluid findings in patients before and during long-term oral zidovudine therapy. Arch Neurol 48:695-9
Tartaglione, T A; Holeman, E; Opheim, K et al. (1990) Zidovudine disposition during hemodialysis in a patient with acquired immunodeficiency syndrome. J Acquir Immune Defic Syndr 3:32-4
Kreiss, J K; Coombs, R; Plummer, F et al. (1989) Isolation of human immunodeficiency virus from genital ulcers in Nairobi prostitutes. J Infect Dis 160:380-4
Tartaglione, T A; Collier, A C (1987) Development of antiviral agents for the treatment of human immunodeficiency virus infection. Clin Pharm 6:927-40