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Development of Protective Immunity in New Zealand White Rabbits Challenged with Bacillus anthracis Spores and Treated with Antibiotics and Obiltoxaximab, a Monoclonal Antibody against Protective Antigen

Lisa N. Henning, Sarah Carpenter, Gregory V. Stark, Natalya V. Serbina

Antimicrobial Agents and Chemotherapy Jan 2018, 62 (2) e01590-17; DOI: 10.1128/AAC.01590-17

Animal-to-Human Dose Translation of Obiltoxaximab for Treatment of Inhalational Anthrax Under the US FDA Animal Rule

Nagy, C., Mondick, J., Serbina, N., Casey, L., Carpenter, S., French, J. and Guttendorf, R.

Clinical And Translational Science. Volume 10, Issue 1, January 2017, Pages 12–19. doi:10.1111/cts.12433

Efficacy Projection of Obiltoxaximab for Treatment of Inhalational Anthrax across a Range of Disease Severity

Brent J. Yamamoto, Annette M. Shadiack, Sarah Carpenter, Daniel Sanford, Lisa N. Henning, Edward O’Connor, Nestor Gonzales, John Mondick, Jonathan French, Gregory V. Stark, Alan C. Fisher, Leslie S. Casey and Natalya V. Serbina

Antimicrob. Agents Chemother. October 2016 vol. 60 no. 10 5787-5795

Obiltoxaximab Prevents Disseminated Bacillus anthracis Infection and Improves Survival during Pre-and Postexposure Prophylaxis in Animal Models of Inhalational Anthrax

Brent J. Yamamoto, Annette M. Shadiack, Sarah Carpenter, Daniel Sanford, Lisa N. Henning, Nestor Gonzales, Edward O’Connor, Leslie S. Casey and Natalya V. Serbina

Antimicrob. Agents Chemother. October 2016 vol. 60 no. 10 5796-5805

Pharmacokinetics and Tolerability of Obiltoxaximab: A Report of 5 Healthy Volunteer Studies

Christa F. Nagy, PhD, Timothy S. Leach, MD, MPH, Joseph H. Hoffman, MD, Arthur Czech, BS, Sarah E. Carpenter, PhD, Robert Guttendorf, RPh, PhD

Clinical Therapeutics/September 2016 Volume 38, Issue 9, Pages 2083-2097

Posters, 2016 ASM Biodefense and Emerging Diseases Research Meeting Presentations, February 8-10, 2016

Animal to Human Dose Translation under the Animal Rule – Obiltoxaximab (ETI-204) Case Study
C. Nagy¹, J. Mondick², N. Serbina¹, L. Casey¹and R. Guttendorf³¹Elusys Therapeutics Inc., Pine Brook, NJ; ²Metrum Research Group LLC, Tariffville, CT; ³Aclairo Pharmaceutical Development Group Inc., Vienna, VA

Safety, Pharmacokinetics and Immunogenicity of Intramuscular (IM) Administration of Obiltoxaximab (ETI-204) to Healthy Humans
A.Czech¹, J. Mondick², R. Guttendorf³, A. King⁴ and C. Nagy¹¹Elusys Therapeutics Inc., Pine Brook, NJ; ²Metrum Research Group LLC, Tariffville, CT; ³Aclairo Pharmaceutical Development Group Inc., Vienna, VA; ⁴Covance Clinical Research Unit, Inc., Dallas, TX

The use of meta-analysis approach to demonstrate added benefit of Obiltoxaximab (ETI-204) in treatment of inhalational anthrax
N. Serbina¹, G. Stark², A. Fisher³, L. Casey¹, R. Slay⁴, and R. Conrad¹¹Elusys Therapeutics, Inc., Pine Brook NJ, ²Battelle BioMed. Res. Ctr., Columbus, OH, ³BDM Consulting, Inc., ⁴NIAID/NIH

Presented at 2015 ASM Biodefense and Emerging Diseases Research Meeting, Washington, DC, February 9-11, 2015

Obiltoxaximab (ETI-204) Efficacy across a Spectrum of Disease Severity in a Trigger-to-Treat Cynomolgus Monkey Inhalational Aerosol Challenge Model of Anthrax
B. Yamamoto¹, N. Serbina¹, S. Carpenter¹, D. Sanford², G. Stark², A. Shadiack^1,3, and L. Casey¹
¹Elusys Therapeutics, Inc., Pine Brook NJ, ²Battelle, Columbus OH, ³Currently at Therapeutics MD, Inc

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