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Aeolus Announces FDA Fast Track Designation Granted to AEOL 10150 for Treatment of Patients With Lung Acute Radiation Syndrome Following a Radiologial or Nuclear Event
Aeolus Announces FDA Fast Track Designation Granted to AEOL 10150 for Treatment of Patients With Lung Acute Radiation Syndrome Following a Radiologial or Nuclear Event.
About this update from Aeolus Pharmaceuticals Inc
[{"type":"text","content":"\nAeolus Announces FDA Fast Track Designation Granted to AEOL 10150 for Treatment of Patients With Lung Acute Radiation Syndrome Following a Radiologial or Nuclear Event\n\nAeolus Announces FDA Fast Track Designation Granted to AEOL 10150 for Treatment of Patients With Lung Acute Radiation Syndrome Following a Radiologial or Nuclear Event\n\n MISSION VIEJO, CA--(Marketwired - June 08, 2017) - Aeolus Pharmaceuticals, Inc. (OTCQB: AOLS), a biotechnology company developing compounds to protect against fibrosis, inflammation, nerve damage and infection announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to AEOL 10150 for the prevention of fatal respiratory failure among patients at risk for radiation pneumonitis following a radiological/nuclear incident sufficient to cause the Acute Radiation Syndrome (\"Lung-ARS\").\"We are pleased that the FDA has granted Fast Track designation to AEOL 10150 for the treatment of Lung-ARS following a radiological or nuclear event,\" said John McManus, President and Chief Executive Officer of Aeolus. \"There are currently no approved treatments for this syndrome and we are not aware of any other compounds in advanced development for this unmet need.\"The purpose of Fast Track is to get important new drugs to patients earlier. It is designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical. A drug that receives Fast Track designation is eligible for Accelerated Approval, Priority Review and Rolling Review, as well as more frequent meetings and written communications with the FDA to discuss development plans and design of proposed clinical trials.About AEOL 10150AEOL 10150 protects tissue from damage and increases survival in animal models of lung damage after exposure to radiation, toxic chemicals, disease and trauma by mitigating and/or preventing cell death, inflammation and fibrosis through its action on oxidative stress and regulation of growth factors and chemokines, as well as impacting subsequent signaling pathways of reactive oxygen species production, apoptosis and fibrosis. We are developing 10150 as a MCM for national defense and for use in oncology and treating lung fibrosis.AEOL 10150 has performed well in preclinical and non-clinical studies, demonstrating statistically s...