Elusys Therapeutics successfully completes human clinical study of anthrax therapeutic

03-May-2006

Elusys Therapeutics Inc. announced the successful completion of a human clinical study for Anthim(TM), the Company's fast-tracked anthrax antibody therapeutic. The Phase I study was designed to determine the safety and tolerability of Anthim(TM) in healthy volunteers, when administered with or without the antibiotic Ciprofloxacin®.

The Principal Investigator for this study, Glen Apseloff, M.D., Division of Clinical Pharmacology at The Ohio State University Clinical Pharmacology Unit commented, "The Anthim Phase 1 study, AH-101, has concluded and all subjects have completed the 42 day study. There were no serious adverse events and the drug was well tolerated, showing a favorable safety risk-profile, when used either alone or in combination with Ciprofloxacin."

Anthim(TM) has been granted fast track status by The Food and Drug Administration (FDA) and is being developed under the FDA Animal Rule, a regulatory process specifically designed for the development of medical countermeasures to bioterror threats. According to this rule, marketing approval of Anthim(TM) can be granted based on efficacy in relevant animal models with an acceptable safety risk profile in humans.

Anthim(TM) is a high-affinity monoclonal antibody that targets the protective antigen component of anthrax, blocking the bacteria's ability to form deadly toxins. In preclinical studies, Anthim(TM) has demonstrated efficacy at lower doses than other drugs in development. A single dose of Anthim(TM) is 100 percent effective in rabbits when administered as a prophylactic and dramatically increases survival rates when given up to 48 hours after exposure. Its low dose allows for rapid intramuscular (IM) delivery, the most effective mode of delivery to both military and civilian personnel in emergency situations.

https://www.bionity.com/en/news/54388/elusys-therapeutics-successfully-completes-human-clinical-study-of-anthrax-therapeutic.html