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Hamouda et al., Sporicidal “6 of BCTP Nanoemulsion Page 1 of 12 The Journal of Infectious Diseases 1999;180:1939-1949 : _ . © 1999 by the Infectious Diseases Society of America. All rights reserved. ALL THPORMATION CONTATNED HEREIN 13 UNCLASSIFIED 0022-1899/1 - . 22-1899/1999/18006-0024$02.00 DATE 12-12-2008 BY 60324 UC EAU/DK/RYS A Novel Surfactant Nanoemulsion with Broad-Spectrum Sporicidal Activity against Bacillus Species Tarek Hamouda,! Michael M. Hayes, Zhengyi Cao,} Richard Tonda,! Kent Johnson,” D. Craig Wright,> Joan Brisker,? and James R. Baker, J rl 'Center for Biologie Nanotechnology and Department of Medicine, and 2Department of Pathology, University of Michigan Medical School, Ann Arbor; 7NOVAVAKX, Inc., Rockville, Maryland Received 10 March 1999; revised 30 June 1999; electronically published 12 November 1999. Two nontoxic, antimicrobial nanoemulsions, BCTP and BCTP 401, have been developed. These emulsions are composed of detergents and oils in 80% water. BCTP diluted up to 1 : 1000 inactivated >90% of Bacillus anthracis spores in 4 h and was also sporicidal against three other Bacillus species. This sporicidal activity is due to disruption of the spore coat after initiation of germination _ without complete outgrowth. BCTP 401 diluted 1 : 1000 had greater activity than BCTP against Bacillus spores and had an onset of action of <30 min. Mixing BCTP or BCTP 401 with Bacillus cereus prior to subcutaneous injection in mice reduced the resulting skin lesion by 99%. Wound irrigation with BCTP 1 h after spore inoculation yielded a 98% reduction in skin lesion size, and mortality was reduced 3-fold. These nanoemulsion formulas are — stable, easily dispersed, nonirritant, and nontoxic compared with other available sporicidal agents. cee Re ee - cree ae mY me arin. eee cee ey ee ee mr a me re Presented in part: 98th general meeting of the American Society for Microbiology, Atlanta, May 1998 (poster A49); 38th Interscience Conference on Antimicrobial Agents and Chemotherapy, San Diego, September 1998 (late-breaker slide session IL, LB-9); 99th general meeting of the American Society for Microbiology, Chicago, May 1999 (poster A300). The animal experiments were approved by and performed according to the guidelines of the Unit for Laboratory Animal Medicine, University of Michigan. , . D.C.W. and J.B. are employees of NOVAVAX, Inc., and have significant financial interest in the company. NOVAVAX, Inc., is the supplier of the emulsions. [R.B., T.H., M@M.H., D. C.W., and J.B. have a patent application entitled: Methods of inactivating bacteria including bacterial spores. Financial support: Defense Advanced Research Project Agency (contract MDA 972-1-007 of the Unconventional Pathogen Countermeasures Program). _ #Present affiliation: Pulmonary/Critical Care Unit—Intermal Medicine, University of Michigan, Ann Arbor. Reprints or correspondence: Dr. James R. Baker, Jr., University of Michigan Medical School, 9220 MSRB-WI, 1150, W. Medical Center Dr., Ann Arbor, MI 48109-0648 (jbakerjr@umich.edu). hitp://www,journals.uchicago.edu/JID/joumal/issues/v1 80n6/990281/990281 text. html 2/18/2005