Aeolus Pharmaceuticals Provides Positive Update on FDA Meeting
Agency Agrees With Choice of Animal Models for Radiation Countermeasure Development Program
MISSION VIEJO, CA--(Marketwire -09/06/12)- Aeolus Pharmaceuticals, Inc. (AOLS) (AOLS), a biotechnology company leveraging significant government funding to develop a platform of novel compounds in oncology and biodefense, today announced the results of its pre-IND meeting held with the Medical Imaging Products Division of the Food and Drug Administration (FDA). The key input from the meeting was as follows:
- The agency agreed with the animal models that the Company has developed for proposed efficacy testing and with the use of mice and non-human primates as the two species for animal efficacy testing.
- FDA also agreed that supportive care should be incorporated in non-human primate studies
- FDA encouraged the Company to submit animal efficacy protocols to the agency for review prior to study initiation.
- FDA provided guidance on non-clinical studies to support the Investigational New Drug application and provided input on the Company's phase 1 Human Safety study design.
- FDA suggested that the company consider parallel development of AEOL 10150 to decrease acute and chronic toxicity from radiation therapy to the chest for certain forms of cancer, and indicated that data from such studies could be used to support the Lung Acute Radiation Syndrome, or Lung-ARS, indication.
"Aeolus is grateful to the Division of Medical Imaging Products for its thoughtful feedback on our development plans for AEOL 10150 as a radiation countermeasure," stated John L. McManus, President & Chief Executive Officer of Aeolus Pharmaceuticals, Inc. "The agency agreed with our animal models and choice of species and provided valuable input into the design of our phase 1 human safety study. We will incorporate their recommendations into our protocol design, and an Investigational New Drug Application in support of a phase 1 protocol."
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 could have a profound beneficial impact on people who have been exposed, or are about to be exposed, to radiation in the treatment of oncology.
AEOL 10150 has already performed well in preclinical and non-clinical studies, was well-tolerated in two human clinical trials, and has demonstrated statistically significant survival efficacy in an acute radiation-induced lung injury animal model. 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 from a nuclear event.
About Aeolus Pharmaceuticals
Aeolus Pharmaceuticals is developing a new class of catalytic antioxidant compounds that protects healthy tissue from the damaging effects of radiation. Its first compound, AEOL 10150, is being developed, with funding by the US Government, as a medical countermeasure against radiological and chemical weapons, where its initial target indications are as a protective agent against the effects of acute radiation syndrome and delayed effects of acute radiation exposure. Aeolus' strategy is to leverage the substantial investment in toxicology, manufacturing, and preclinical and clinical studies made by US Government agencies in AEOL 10150, including the contract with BARDA valued, with options, at up to $118 million, to efficiently develop the compound for use in oncology.
The statements in this press release that are not purely statements of historical fact are forward-looking statements. Such statements include, but are not limited to, those relating to Aeolus' product candidates, as well as its proprietary technologies and research programs. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Aeolus' actual results to be materially different from historical results or from any results expressed or implied by such forward-looking statements. Important factors that could cause results to differ include risks associated with uncertainties of progress and timing of clinical trials, scientific research and product development activities, difficulties or delays in development, testing, obtaining regulatory approval, the need to obtain funding for pre-clinical and clinical trials and operations, the scope and validity of intellectual property protection for Aeolus' product candidates, proprietary technologies and their uses, and competition from other biopharmaceutical companies. Certain of these factors and others are more fully described in Aeolus' filings with the Securities and Exchange Commission, including, but not limited to, Aeolus' amended Annual Report on Form 10-K/A for the year ended September 30, 2011. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.