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news.Aeolus Pharmaceuticals has reported 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.
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The 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 optimise dose and duration of delivery, and to evaluate the window of opportunity for treatment after exposure.
A study completed last year in preclinical models 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.
The study protocol calls for the animals to receive 15 Gy of partial body irradiation with 40% of bone marrow shielded (PBI/BM40). 20 days after exposure researchers are expected to 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.
Reportedly, 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.
Catherine Booth, managing director of contract research services at Epistem, said: “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.”
John McManus, president and CEO of Aeolus Pharmaceuticals, said: “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. 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.”