Health & Fitness
Health and Fitness
Health and Fitness
Tue, November 2, 2010
Aeolus Pharmaceuticalsa? AEOL 10150 Promotes Survival in Non-Human Primates Exposed to Lethal Doses of Radiation
MISSION VIEJO, Calif.--([ BUSINESS WIRE ])--Aeolus Pharmaceuticals, Inc. (OTCBB:AOLS) today announced preliminary results showing that AEOL 10150 promotes survival in a proof of principle study conducted in a non-human primate model of Pulmonary Acute Radiation Syndrome (ARS). The study included 13 animals, of which 6 were control animals and 7 received AEOL 10150. While none of the six control animals survived the 180 day study period, 2 of the 7 (or 28.5%) of the animals receiving drug survived.
AEOL 10150 has now demonstrated a survival advantage in two species of animals exposed to lethal doses of radiation. The Company has a proposal under review by the Biomedical Advanced Research and Development Authority (BARDA) for further funding of the development of the compound as a medical countermeasure for the effects of radiation exposure on the lungs.
The primary objective of the study was to determine if AEOL 10150 could mitigate radiation-induced lung injury and enhance survival in rhesus macaques exposed to whole thorax lung irradiation (WTLI) and administered supportive care. Two cohorts of Non-Human Primates (NHP) (total n=13) were exposed to 11.5Gy LINAC-derived photon radiation in the WTLI protocol. The control cohort had n=6 and AEOL-treated cohort was n=7. This model showed 100% incidence of severe radiation-induced lung damage. AEOL 10150 was administered subcutaneously at 5mg/kg beginning at day 1 post WTLI and continued as a single, daily injection for 28 consecutive days.
All other clinical parameters are in process of being analyzed and collated. Some of the key measurements include: respiratory rate, pulse oximetry for SpO2 values and histological examination (special stains will be used to determine presence and degree of fibrosis, alveolar space, cellular infiltration and oxidative damage). Final results of the study are expected before year-end.
About AEOL 10150
AEOL 10150 is a small molecule that catalytically consumes reactive oxygen and nitrogen species (free radicals). The compound is a manganoporphyrin that contains a positively-charged manganese metal ion that is able to accept and give electrons to and from reactive oxygen species (aROSa) and reactive nitrogen species (aRNSa). Research has shown that ROS and RNS have important cell signaling roles, and through its interaction with RNS and ROS, AEOL 10150 appears to have multiple mechanisms of action including anti-oxidant, anti-inflammatory and anti-angiogenic activities. In preclinical studies AEOL 10150 has demonstrated reductions in the markers for tissue hypoxia, angiogenesis, inflammation and oxidative stress. Specifically, AEOL 10150 is able to down-regulate oxidative stress and severe inflammation, which is responsible for much of the tissue destruction that occurs as a result of radiation exposure.
Potential for AEOL 10150 as a Countermeasure Against Multiple Terrorist Threats
AEOL 10150 has shown significant protective effects against radiation and chlorine gas and mustard gas in preclinical models. A compound with the potential to protect against multiple threats would be of significant benefit in both the military and civilian efforts to protect citizens against potential threats. The FDA has a special rule under which compounds may be approved for use against chemical and nuclear threats on the strength of preclinical efficacy studies, which allows the potential for an accelerated approval path versus conventional pharmaceutical applications.
AEOL 10150 offers several unique advantages as a countermeasure for the treatment of ARS, mustard gas and chlorine gas for civilian and military populations. These include:
-- Flexible Treatment Paradigm a" AEOL 10150 is intended for the treatment of patients post-exposure, even in those who are already exhibiting symptoms, eliminating the need for immediate administration in a predefined treatment window. This approach has the added benefit of not requiring biodosimetry (a means of laboratory analysis of the blood to determine the level of radiation exposure).
-- Advanced Development Stage a" AEOL 10150 has demonstrated safety in three human clinical trials, and has an extensive pre-clinical safety and toxicology package completed. The product also has an established stability profile that permits long-term storage.
-- Large scale manufacturing a" Aeolus has contract capacity with a large manufacturing site to mass produce large quantities of AEOL 10150 under GMP conditions.
-- Multiple Applications a" AEOL 10150 has demonstrated protective effects against radiation and mustard gas exposure, and within these indications has shown the ability to treat multiple organ systems.
-- Commercial Application a" Additionally, AEOL 10150 is being developed for use as an adjunct to cancer radiation therapy, and preclinical data suggest that the compound protects healthy normal cells from the effects of radiation without compromising the efficacy of the radiation in killing tumor cells.
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. Aeolusa™ strategy is to leverage the substantial investment in toxicology, manufacturing, and preclinical and clinical studies made by US Government agencies in AEOL 10150 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 Aeolusa™ 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 Aeolusa™ 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 Aeolusa™ product candidates, proprietary technologies and their uses, and competition from other biopharmaceutical companies. Certain of these factors and others are more fully described in Aeolusa™ filings with the Securities and Exchange Commission, including, but not limited to, Aeolusa™ Annual Report on Form 10-K for the year ended September 30, 2009. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.
