NIAID funds second study of Aeolus Pharmaceuticals' AEOL 10150 as potential countermeasure to GI-ARS

Aeolus Pharmaceuticals, Inc. (OTC Bulletin Board: AOLS) announced today that a second study of its lead drug, AEOL 10150, has been initiated by the National Institutes of Health's (NIH), National Institute of Allergy and Infectious Diseases (NIAID) Radiation/Nuclear Medical Countermeasures development program as a countermeasure for radiation exposure to the gastrointestinal (GI) tract. This study, funded by NIAID, is designed to test the efficacy of AEOL 10150, as measured by survival advantage, as a treatment for damage to the GI tract due to exposure to radiation. If effective, additional studies could be funded to optimize dose and duration of delivery, and to evaluate the window of opportunity for treatment after exposure.

“There are currently no treatments for the loss of gastrointestinal barrier function caused by cancer therapies or terrorist nuclear attack”

A study completed last year in preclinical models conducted by the National Institutes of Health's (NIH), National Institute of Allergy and Infectious Diseases (NIAID), through a contract to the University of Maryland School of Medicine's Medical Countermeasures Against Radiological Threats (MCART) program, showed that AEOL 10150 can effectively increase regeneration of gastro-intestinal (GI) stem cells, reduce the severity and duration of diarrhea and improve survival when administered at 24 hours after doses of total-body irradiation that produce the lethal GI syndrome. There are no published studies of agents that accomplish this enhanced stem cell regenerative effect while maintaining GI function and improving survival when administered post irradiation.

"There are currently no treatments for the loss of gastrointestinal barrier function caused by cancer therapies or terrorist nuclear attack," stated Catherine Booth, Ph.D., Managing Director, Contract Research Services at Epistem, Ltd. "This data generated by AEOL 10150 showed increased intestinal crypt regeneration with resulting improvements in animal well being. The potential clinical uses for such a disease mitigator are very exciting."

The study protocol calls for the animals to receive 15 Gy of partial body irradiation with 40 percent of bone marrow shielded (PBI/BM₄₀). Twenty days after exposure researchers will examine both histological and survival endpoints in C57BL/6 mice in a multi-armed vehicle-controlled trial. Survival will be the primary endpoint, with diarrhea being the secondary endpoint in the study. Animals receiving AEOL 10150 will begin dosing 24 hours after radiation exposure and receive one dose per day for either 10 or 20 days total. Preliminary results from the study are expected during the second quarter of 2010.

These studies are being conducted by Epistem, in compliance with criteria of the FDA that are a pre-requisite for movement of the Aeolus drug along the pathway for FDA licensure to treat lethally irradiated persons in the event of a terrorist nuclear act. Epistem operates a major contract research organization and provides services to identify novel drugs that can protect or improve the repair of the gastrointestinal (GI) tract following exposure to irradiation and performed these studies as part of its US National Institute of Health's (NIH) program for the screening of a novel agents for bio-defense applications.

"We are honored that NIH, NIAID has decided to fund a second study of AEOL 10150 as a potential countermeasure to GI Acute Radiation Syndrome (GI-ARS), based on the positive results seen in the proof of principle study conducted by NIAID last year. Positive survival data in this study would build on the statistically significant survival advantage the compound has shown in Lung Acute Radiation syndrome and would further support 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 that we saw in the first GI ARS study."

The NIH NIAID MCART development program leads the U.S. effort to develop treatments for radiation sickness following a nuclear terrorist attack. GI-ARS is a massive, currently untreatable, problem following high-dose, potentially lethal radiation exposure. Agents that mitigate these effects would reduce sickness and hopefully prevent fatalities. 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. Risk of injury to the intestine is dose-limiting during abdominal and pelvic radiation therapy—interventions that limit post-irradiation intestinal dysfunction would have significant impact in large number of patients, estimated to be between 1.5 to 2 million cancer survivors with post-irradiation intestinal dysfunction. AEOL 10150 has previously demonstrated protective effects in protecting healthy normal cells from damage occurring due to cancer radiation therapy in preclinical models.