Acute Radiation Syndrome

National Institutes of Health’s National Institute for Allergy and Infectious Diseases Initiates Study of Aeolus Pharmaceutical Drug as a Countermeasure for Radiation Exposure

The study protocol calls for the examination of both histological and survival endpoints in C57BL/6 mice in a multi-armed vehicle-controlled trial. For the histological portion, crypt histology will be assessed with crypt number and crypt width being the primary endpoint. Animals receiving AEOL 10150 began dosing 24 hours after radiation exposure and receive one dose per day for the remainder of the study. Preliminary results from the study are expected during the third quarter of 2009.

"We are honored to be chosen by NIH, NIAID to participate in the MCART program, and are pleased that the first study in GI-ARS has begun. We believe that AEOL 10150's selection says a great deal about the compounds potential to provide multi-organ protection in Acute Radiation Syndrome," stated John L. McManus, President and Chief Executive Officer of Aeolus Pharmaceuticals, Inc. "We look forward to the completion of the study and hope to see the same positive effects in the GI tract that we have seen the drug demonstrate in the protection of lung cells from radiation."

The National Institutes of Health's (NIH), National Institute of Allergy and Infectious Diseases (NIAID) Radiation/Nuclear Medical Countermeasures development program leads the U.S. effort to develop treatments for radiation sickness following a nuclear terrorist attack. GI-ARS is a potentially fatal, currently untreatable, problem following high-dose radiation exposure. Agents that mitigate these effects could reduce sickness and hopefully prevent fatalities. There are currently no medications approved by the FDA to treat this syndrome.

The tests performed by NIH/NIAID are also likely to identify agents with oncology supportive care applications - agents that will reduce the severe ulceration and diarrhea (mucositis) experienced by patients during radio- and chemo-therapy. AEOL 10150 has previously demonstrated protective effects in protecting healthy normal cells from damage occurring due to cancer radiation therapy in animals. About AEOL 10150 AEOL 10150 is a small molecule that catalytically consumes reactive oxygen and nitrogen species (free radicals). The compound is a manganoporphyrin that contains a positively-charged manganese metal ion that is able to accept and give electrons to and from reactive oxygen species ("ROS") and reactive nitrogen species ("RNS"). Research has shown that ROS and RNS have important cell signaling roles, and through its interaction with RNS and ROS, AEOL 10150 appears to have multiple mechanisms of action including anti-oxidant, anti-inflammatory and anti-angiogenic activities. In animal studies AEOL 10150 has demonstrated reductions in the markers for tissue hypoxia, angiogenesis, inflammation and oxidative stress. Specifically, AEOL 10150 is able to down-regulate oxidative stress and severe inflammation, which is responsible for much of the tissue destruction that occurs as a result of radiation exposure.

Keywords: , Health, Biotechnology, Clinical Trials, Infectious Diseases, Pharmaceutical, Defense, Other Defense, ReseAcute Radiation Syndrome, Allergies, Allergy Medicine, Clinical Trial Research, Gastroenterology, Histology, Pharmaceuticals, Aeolus Pharmaceuticals Inc.

This article was prepared by Biotech Business Week editors from staff and other reports. Copyright 2009, Biotech Business Week via NewsRx.com.