MISSION VIEJO, CA--(Marketwire - June 01, 2012) - Aeolus Pharmaceuticals, Inc. (OTCQB: AOLS) (OTCBB: AOLS), a biotechnology company leveraging significant government funding to develop a platform of novel compounds in oncology and biodefense, today announced additional results from a study of AEOL 10150 and Neupogen® conducted by Christie Orschell, PhD, of Indiana University, building on initial results released in November 2011. Analysis of tissue 65 and 135 days after total body irradiation (TBI) exposure of 7.0 Gy demonstrated that treatment of the hematopoetic sub-syndrome of acute radiation syndrome (Heme-ARS) with Neupogen® exacerbates radiation damage to the lung. The study also confirmed that treatment with AEOL 10150 in combination with Neupogen® significantly reduced the lung damage.
Neupogen® has been shown to be an effective treatment for the Heme-ARS at radiation doses as low as 6.0 Gy, and is considered a standard therapy for radiation exposure. It has already been acquired for the strategic national stockpile. While the compound significantly improves the response of the hematopoetic system after radiation exposure it also increases the neutrophil count in the lungs, which increases damage to lung tissue. At 65 days post exposure approximately 42 percent of lung tissue in this study was severely damaged. Treatment with Neupogen plus AEOL 10150 reduced lung damage to approximately 21 percent. At both 65 and 135 days post-exposure, treatment with AEOL 10150 also reduced fibrosis, alveolar and perivascular inflammation resulting from 7.0 Gy radiation and treatment with Neupogen ®. Analysis of the impact of Neupogen and AEOL 10150 on the GI tract is currently underway.
"We previously reported that AEOL 10150 does not interfere with the positive effects of Neupogen® on the Heme-ARS, and the two products in combination were safe and well tolerated. We also reported that AEOL 10150 has demonstrated a survival advantage against the pulmonary syndrome of ARS at radiation exposure of up to 15 Gy in mice," stated John L. McManus, President and Chief Executive Officer of Aeolus Pharmaceuticals, Inc. "This new data shows that the combined effects of the two drugs could improve outcomes for patients requiring therapy for Acute Radiation Syndrome at levels of radiation of 7.0 Gy or lower."
The study titled, "Pilot Study to Test the Effects of Aeolus 10150 on Neupogen®-Induced ANC Recovery in Sub-Lethally Irradiated C57Bl/6 Mice" was initiated at the request of Shigetaka Asano, MD, of Waseda University and Arinobu Tojo, MD, PhD, and Tokiko Nagamura, MD, at the Institute of Medical Science at the University of Tokyo to determine whether there would be any interference with the demonstrated efficacy of Neupogen® as a medical countermeasure against the hematopoietic complications of radiation exposure. In previous treatment of radiation accident victims at Tokai-mura, Dr. Asano and others were able to use Granulocyte Colony Stimulating Factor (G-CSF) and supportive care to enable victims of 8 to 12 Gy exposure to survive the heme-syndrome. Unfortunately, these patients later died due to lung and multi-organ complications. As AEOL 10150 has shown efficacy against lung and GI complications in mice and in lung ARS in non-human primates, it was important to test whether the two compounds can be used in tandem, if necessary.
The use of Neupogen®, or other G-CSFs, or Neulasta®, or other Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) products, is recommended by the Radiation Emergency Assistance Center/Training Site (REAC/TS) at radiation exposures greater than 2 Gy to mitigate damage to the hematopoietic system. REAC/TS is a response asset of the U.S. Department of Energy and provides treatment capabilities and consultation assistance nationally and internationally. In animal studies G-CSF's have been shown to be effective in increasing survival at levels up to 7.5 Gy due to their positive effects on the hematopoietic damage created by radiation exposure. This class of compounds has not demonstrated a positive effect on the two other major sub-syndromes -- GI and Lung. AEOL 10150 has demonstrated efficacy in treating the GI sub-syndrome in pilot studies conducted by NIH-NIAID, by protecting crypt cells and reducing diarrhea. More extensive studies of the drug in treating the pulmonary effects of radiation at Duke University and the University of Maryland have shown improved survival and enhanced lung function, including improved histology, at exposures up to 15 Gy in mice and 11.5 Gy in non-human primates. These exposure levels caused death in 100 percent of untreated animals. Studies at Duke University have also shown a significant survival advantage for animals treated with AEOL 10150 after 15 Gy upper half body irradiation, which causes lethal damage to both the GI tract and the lungs.
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 high-doses of 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 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, whether from cancer therapy or 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 for oncology indications, where it is used in combination with radiation therapy. It is also being developed, with funding by the US Government, as a medical countermeasure against chemical and radiological 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, 2010. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.