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Aeolus Initiates Phase 1 Study of AEOL 10150 in Healthy Normal Volunteers
Aeolus Initiates Phase 1 Study of AEOL 10150 in Healthy Normal Volunteers.
About this update from Aeolus Pharmaceuticals Inc
[{"type":"text","content":"\nAeolus Initiates Phase 1 Study of AEOL 10150 in Healthy Normal Volunteers\n\nAeolus Initiates Phase 1 Study of AEOL 10150 in Healthy Normal Volunteers\n\nMISSION VIEJO, CA--(Marketwired - February 22, 2017) - Aeolus Pharmaceuticals, Inc. (OTCQB: AOLS), a biotechnology company developing compounds to protect against fibrosis, inflammation, nerve damage and infection, announced today the initiation of a phase 1 study with its lead compound AEOL 10150. The phase 1 study is an open-label, single center, dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics of an escalating single dose of AEOL 10150 administered by subcutaneous injection in healthy subjects. AEOL 10150 is being developed as a treatment for the lung and delayed effects of acute radiation exposure (Lung-ARS) under a $118.4 million advanced research and development contract with the Biomedical Advanced Research and Development Authority (\"BARDA\"). BARDA is the division of the U.S. Department of Health and Human Services responsible for the development and purchase of medical countermeasures for chemical, biological, radiological and nuclear threats. In addition, AEOL 10150 is being developed as a treatment for idiopathic pulmonary fibrosis (IPF) and for use in conjunction with radiation therapy to treat solid tumors. This study will expand the safety database for AEOL 10150 and will be the first set of human safety data for the new formulation of AEOL 10150 developed under the BARDA contract. The data from this study will be included in the Company's pre-Emergency Use Authorization application in Lung-ARS and will also be used to support the IPF and radiation therapy indications, as well as the use of AEOL 10150 as a medical countermeasure against lung damage from exposure to sulfur mustard gas. Prior studies with the original formulation in single and multiple dose studies of 39 patients with Amyotrophic Lateral Sclerosis (\"ALS\"), demonstrated that AEOL 10150 was safe and well tolerated. The new formulation of AEOL 10150 is significantly cheaper than the prior formulation and is the subject of new patents pending with the US and global patent authorities. Additional toxicology work completed with Aeolus and BARDA funding has led to FDA concurrence to test the drug in healthy normal volunteers and animal efficacy data generated under the...