The secondary endpoints for the study were survival and H2A.X phosphorylation. Survival for animals exposed to NM and treated with AEOL 10150 subcutaneously was 75 percent, compared to 25 percent in the control group (NM plus PBS). Survival for animals exposed to NM and treated subcutaneously and topically with AEOL 10150 was 100 percent, compared to 38 percent in the control group (NM plus PBS and gel). Treatment with AEOL 10150 reversed NM-induced H2A.X phospohorylation in mouse skin by 34 percent (subcutaneous only) and by 75 percent (subcutaneous plus topical).
"AEOL 10150 continues to demonstrate significant efficacy as a broad spectrum countermeasure against both chemical and radiological effects, which we believe position it uniquely as a candidate for use to protect citizens and warfighters," stated John L. McManus, President and Chief Executive Officer of Aeolus Pharmaceuticals, Inc. "We are grateful to NIH CounterACT for their support of this program, and to Dr. Day, Dr. Rajesh Agarwal and Dr. Carl White for their continuing efforts to find effective countermeasures for potential chemical threats. With this efficacy data, we now have 7 indications for which AEOL 10150 has demonstrated efficacy as countermeasure against chemical and radiological threats."
CounterAct Center of Excellence
In 2011, the NIH, through its Countermeasures Against Chemical Threats Research Network (CounterACT) awarded a five-year, $12.7 million grant to Carl White, MD, Rajesh Agarwal, PhD and Brian Day, PhD of the University of Colorado Anschutz Medical Campus and National Jewish Health, both in Denver, Colorado. The grant was awarded to continue the development of AEOL 10150 as a medical countermeasure (MCM) against mustard gas exposure (lung and skin) and chlorine gas exposure (lung). Also included in the grant is support of research looking at tissue plasminogen activator (TPA) and Silabilin as MCM's against sulfur mustard gas exposure.
Potential for AEOL 10150 as a Countermeasure Against Chemical Threats
AEOL 10150 has shown significant protective effects against radiation, sulfur mustard gas, nitrogen mustard gas, chlorine gas, phosgene gas and nerve agents in animal models. A compound with the potential to protect against multiple threats would be of significant benefit in both the military and civilian efforts to protect citizens against potential threats. The United States Food and Drug Administration (FDA) has a special "Animal Rule" under which compounds may be approved for use against chemical and nuclear threats on the strength of animal efficacy studies, which allows the potential for an accelerated approval path versus conventional pharmaceutical applications.
About AEOL 10150
AEOL 10150 is a broad-spectrum catalytic antioxidant 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. AEOL 10150 may have a profound beneficial impact on people who have been exposed, or are about to be exposed, to high-doses of radiation in the treatment of oncology.
AEOL 10150 has performed well in preclinical and non-clinical studies, demonstrating statistically significant survival efficacy in an acute radiation-induced lung injury model, and was well-tolerated in two human clinical trials. The Company believes it could have a profound beneficial impact on people who have been exposed, or are about to be exposed, to high-doses of radiation, whether from cancer therapy or a nuclear event.
Most Popular Stories
- Boehner Lashes Out Against Ted Cruz, Far Right
- TFA Recruiting DACA Recipients
- Bitcoin or Bad Coin? Warnings Mount Against Virtual Currency
- Cheap Gas Drives Down U.S. Wholesale Prices Again
- Expanding Medicaid Creates Jobs: Study
- Robert Levinson Was on CIA Mission
- Producer Price Index Dropped in November
- Beyonce Releases New Album With No Marketing
- Hawaii Official Who Release Obama Certificate Only Victim of Plane Crash
- 'Dreamers' Hope for Permanent Immigration Status