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aeolus pharmaceuticals inc (IC9A) Details

Aeolus Pharmaceuticals, Inc., a biopharmaceutical company, is engaged in the development of a platform of novel compounds in biodefense and oncology. The company develops a class of catalytic antioxidant compounds as medical countermeasures against biological, chemical, and radiological weapons, as well as for diseases and disorders of the central nervous system, respiratory system, autoimmune system, and oncology. Its lead compound, AEOL 10150, which has completed 2 Phase I clinical trials is developed against the pulmonary sub-syndrome of acute radiation syndrome, as well as for the gastrointestinal sub-syndrome of acute radiation syndrome; and for use as a medical countermeasure for exposure to chemical vesicants, such as chlorine gas, sulfur mustard gas, phosgene gas, and nerve agents. The company is also developing AEOL 11207, AEOL 10113, and AEOL 10171 for the treatment of epilepsy and Parkinson’s disease. Aeolus Pharmaceuticals, Inc. was founded in 1994 and is based in Mission Viejo, California.

Founded in 1994

aeolus pharmaceuticals inc (IC9A) Top Compensated Officers

Chief Executive Officer and President
Total Annual Compensation: $421.3K
Chairman of The Board, Chief Financial Office...
Total Annual Compensation: $342.3K
Compensation as of Fiscal Year 2013.

aeolus pharmaceuticals inc (IC9A) Key Developments

Aeolus Pharmaceuticals, Inc. Files Investigational New Drug Application With US FDA to Enable Initiation of Human Safety Studies for the Development of AEOL as a Medical Countermeasure against Lung Damage from Radiation Exposure

Aeolus Pharmaceuticals Inc. has filed an Investigational New Drug Application (IND) with the Division of Medical Imaging Products of the US Food and Drug Administration (FDA) to enable the initiation of a phase 1 study of AEOL 10150 in healthy human volunteers. The new phase 1 study is designed as the first step in meeting the requirements for approval of the drug as a medical countermeasure for lung damage due to radiation exposure (Lung-ARS) under the FDA's "Animal Rule." Aeolus is developing AEOL 10150 for this indication under a five-year contract with the Biomedical Advanced Research and Development Authority (BARDA) valued at up to $118 million. AEOL 10150 has previously been tested in 39 patients with Amyotrophic Lateral Sclerosis (ALS) in two phase 1 safety studies where it was well-tolerated with no Serious Adverse Events (SAE) reported. Through work performed under the BARDA contract, the manufacturing process and formulation of AEOL 10150 has been improved and the manufacturing cost has been reduced by approximately 90 percent. Bridging studies comparing the new, improved formulation of AEOL 10150 to the old formulation were recently completed. The old formulation met FDA regulatory/toxicity guidelines for clinical administration in multiple human studies. The new regulatory compliant (GLP) studies demonstrated that the toxicity and pharmacokinetics of the formulations were comparable. These studies also showed that the new formulation is less likely to cause irritation and has superior bioavailability in animals. Stability studies with the new formulation have thus far demonstrated stability up to 24 months at room temperature and refrigerated conditions. Stability testing will continue to 60 months. Efficacy studies in mice and non-human primates have shown that AEOL 10150 improves survival and reduces lung damage when given 24 hours after exposure to lethal levels of radiation. Lung ARS is a problem for which there is currently no approved treatment and the damage typically proves to be fatal in humans as well as in non-human primates and rodents. Assuming that the FDA accepts the IND and clinical protocol without restriction and that BARDA exercises the necessary program options, Aeolus plans to initiate a phase 1 study in healthy normal volunteers during the fourth quarter of 2014. Aeolus currently has an IND in place with the FDA for ALS, and received orphan drug designation for lung damage resulting from Acute Radiation Syndrome (ARS) from the FDA's Office of Orphan Product Development earlier this year. A filing for Fast Track Status is planned before the end of 2014. The Company also plans to file INDs for the development of AEOL 10150 in radiation therapy and for a respiratory disorder within the next 3 to 12 months. 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 resulting from radiation exposure. The Company believes that AEOL 10150 could have a profound beneficial impact on people who are exposed to high doses of radiation. AEOL 10150 has already performed well in animal safety studies, was well-tolerated in two human clinical trials and has demonstrated statistically significant survival efficacy in multiple Lung-ARS studies in animals. Aeolus has received "Orphan Drug" designation for the use of AEOL 10150 in treating lung ARS, and has filed an IND to allow for human safety testing of the compound in healthy volunteers. AEOL 10150 is also currently in development for use as both a therapeutic and prophylactic drug in cancer patients.

Aeolus Pharmaceuticals Inc. Reports Unaudited Consolidated Earnings Results for the Third Quarter and Nine Months Ended June 30, 2014

Aeolus Pharmaceuticals Inc. reported unaudited consolidated earnings results for the third quarter and nine months ended June 30, 2014. For the quarter, the company’s contract revenue was $4,983,000 against $844,000 a year ago. Income from operations was $1,576,000 against loss of $786,000 a year ago. Net income was $1,576,000 or $0.01 per basic and diluted share against net loss of $786,000 or $0.01 per basic share a year ago. For the nine months, the company’s contract revenue was $7,214,000 against $3,045,000 a year ago. Income from operations was $445,000 against loss of $2,031,000 a year ago. Net income was $445,000 or $0.00 per basic and diluted share against net loss of $2,541,000 or $0.03 per basic and diluted share a year ago. Net cash provided by operating activities was $403,000 against net cash used in operating activities of $1,107,000 a year ago.

Aeolus Pharmaceuticals, Inc. Announces Data Demonstrating Efficacy of AEOL 10150 in Animal CEES Model of Mustard Gas Skin Exposure

Aeolus Pharmaceuticals Inc. announced the publication of data from animal model studies demonstrating the efficacy of AEOL 10150 when used to treat skin lesions from the sulfur mustard gas analog CEES. The key findings described in the publication include: Treatment of mice with AEOL 10150 resulted in over 50%(p < 0.05) reversal of CEES-induced skin bi-fold and epidermal thickness, myeloperoxidase activity, and DNA oxidation in mouse skin; Treatment of mouse epidermal JB6 and human HaCaT cells with AEOL 10150 (50 uM) 1 hour post-CEES exposure resulted in significant (p < 0.05) reversal of CEES-induced decreases in both cell viability and DNA synthesis; AEOL 10150 treatment 1 hour after CEES exposure attenuated CEES-induced DNA damage in mouse epidermal JB6 and human HaCaT cells; Cytoplasmic and mitochondrial reactive oxygen species measurements showed that AEOL 10150 treatment drastically ameliorated the CEES-induced oxidative stress in both JB6 and HaCaT cells.

 

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