AEOL-10150 is currently the subject of multiple programs funded by the U.S. Government aimed at developing the compound as a medical countermeasure against national security threats. AEOL 10150 has already performed well in animal safety studies, been well-tolerated in two human clinical trials and demonstrated efficacy in two species in acute radiation syndrome (“ARS”) studies. AEOL 10150 has also demonstrated efficacy in validated animal models for chlorine gas exposure, and sulfur mustard gas exposure.
Acute Radiation Syndrome – Lung
Our lead compound, AEOL 10150, is being developed as a medical countermeasure for the pulmonary effects of Acute Radiation Syndrome (“Lung-ARS”) under a $118MM, 5 year contract from the Biomedical Advanced Research and Development Authority (“BARDA”), a division of the U.S. Department of Health and Human Services. The contract was awarded in February 2011 and fully funds all development activities required for FDA approval under the Animal Rule. In addition, the BARDA contract funds the development of large scale manufacturing capability sufficient to meet potential large orders from the government. If the development program is successful, AEOL-10150 would be a candidate for procurement for the U.S. Strategic National Stockpile.
Efficacy has been demonstrated in Lung-ARS in both monkey and mouse studies with AEOL 10150 treated groups showing significantly reduced weight loss, inflammation, oxidative stress, lung damage and, most importantly, mortality. Therapeutic efficacy was demonstrated when administered after 24 hours after exposure to radiation. Radiation exposure is considered a Priority Threat by the U.S. Government.
AEOL-10150 is a metalloporphyrin specifically designed to neutralize reactive oxygen and nitrogen species. The neutralization of these species reduces oxidative stress, inflammation, and subsequent tissue damage-signaling cascades resulting from radiation exposure.
We have an active Investigational New Drug Application (“IND”) on file with the FDA for AEOL 10150 as a potential treatment for amyotrophic lateral sclerosis (“ALS”). Extensive toxicology and pharmacology packages are already in place. We have already completed two Phase 1 safety studies in 50 humans demonstrating the drug to be safe and well tolerated. Significant Chemistry, Manufacturing, and Controls(“CMC”) work has been completed and we plan to manufacture registration batches of GMP bulk drug in the first half of 2015.
Chemical Gas – Vesicants
The National Institutes of Health’s (“NIH”) Countermeasures Against Chemical Threats (“CounterACT”) has tested, and continues to test, AEOL 10150 as a medical countermeasure for exposure to chemical vesicants such as chlorine gas and sulfur mustard gas. Efficacy has been demonstrated in multiple trials in rodent models. We intend to meet with the FDA to discuss a large animal model for sulfur mustard gas exposure and a pathway to approval under the Animal Rule.
Chemical Gas – Nerve Gas
The National Institutes of Health’s (“NIH”) Countermeasures Against Chemical Threats (“CounterACT”) has tested, and continues to test, AEOL 10150 as a medical countermeasure for exposure to nerve gas, such as sarin. Results from animal studies under this program demonstrated that AEOL 10150 improves survival when added to the current standard of care in animals exposed to a nerve agent surrogate for sarin gas. Successful development under this program (and the chemical vesicant program) would make AEOL 10150 a treatment for multiple national security threats (radiation, vesicants, nerve gas), increasing its attractiveness as a candidate for procurement into the U.S. Strategic National Stockpile. Nerve gas exposure is considered a Priority Threat by the U.S. Government.
We are leveraging the significant investment made by U.S. government agencies to develop this promising compound for use in oncology indications, where it would be used in combination with radiation therapy. Data has already been published showing that AEOL 10150 does not interfere with the therapeutic benefit of radiation therapy in prostate and lung cancer preclinical studies. Based on the work completed under the BARDA contract, we believe that we will be positioned to begin Phase II studies in radiation oncology in 2015. We intend to develop AEOL-10150 concurrently with the BARDA program for use in radiation oncology.