SAN DIEGO, March 13 /PRNewswire-FirstCall/ -- Aeolus Pharmaceuticals, Inc. , a developer of a new class of disease-modifying compounds with potent activity in pre-clinical models of central nervous system diseases and oncology, announced today that it has received a milestone payment and equity consideration from ARCA Discovery, Inc., a privately held cardiovascular-focused company ("ARCA"). In 2003, CPEC, LLC ("CPEC"), a limited liability company owned by Aeolus (35%) and Indevus Pharmaceuticals, Inc. (65%), out-licensed all rights to a potential therapeutic compound referred to as "bucindolol" to ARCA. Both the cash payment and equity consideration received by Aeolus are based upon Aeolus' ownership interest in CPEC, and a renegotiation of certain terms of the 2003 agreement between CPEC and ARCA.
Richard P. Burgoon, Jr., Chief Executive Officer to Aeolus, noted that, "The cash payment from this milestone will be used to further the development of Aeolus' catalytic antioxidant technology." Mr. Burgoon further commented that, "We are pleased to see progress in the development of bucindolol, a compound with potential for the treatment of heart failure."
The $350,000 payment received by Aeolus was triggered by ARCA receiving investment funding. The equity consideration to Aeolus was consideration for a modification of the license agreement between CPEC and ARCA. Future milestone payments and royalty payments to Aeolus, if any, while provided for under the agreement between CPEC and ARCA, can not be assured nor guaranteed.
Bucindolol was previously evaluated in Phase III clinical studies, and although the drug was found to be safe, these prior Phase III clinical studies were discontinued in 1999 following an interim analysis of the data. The interim data analysis revealed that some subpopulations within the study appeared to benefit from the drug, while other subpopulations did not. In total, bucindolol has been evaluated in Phase III clinical trails involving more than 3,000 patients with advanced heart failure and myocardial ischemia.
About Aeolus Pharmaceuticals
Aeolus is developing a variety of therapeutic agents based on its library of 200 proprietary small molecule catalytic antioxidants, with AEOL 10150 being the first to enter human clinical evaluation. AEOL 10150 is a patented, small molecule catalytic antioxidant that has shown the ability to scavenge a broad range of reactive oxygen species, or free radicals. As a catalytic antioxidant, AEOL 10150 mimics and thereby amplifies the body's natural enzymatic systems for eliminating these damaging compounds. Aeolus has completed a Phase I dose escalating safety study of AEOL 10150 in patients diagnosed with Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig's disease), which demonstrated that the drug is safe at the tested doses with no serious adverse events, and has to date complete two multiple dose cohorts of a planned three dose- multiple dose study-the completed doses were 40 mg, twice daily (80 mg total per day) for 6 days and a single 40 mg administration on the 7th day, and 60 mg, twice daily (120 mg total per day) for 6 days and a single 60 mg administration on the 7th day. In both cases the drug was safe with no serious adverse events. Because oxygen-derived free radicals are believed to have an important role in the pathogenesis of many diseases, Aeolus' catalytic antioxidants are believed to have a broad range of potential therapeutic uses. The Aeolus Pipeline Initiative, begun in the third calendar quarter of 2005, is an internal development initiative focused on advancing, in addition to AEOL 10150, several of the most promising catalytic antioxidant compounds from Aeolus' proprietary library of 200 compounds. The initial therapeutic focus areas for the Aeolus Pipeline Initiative are: Parkinson's disease; Cystic Fibrosis; Chronic Obstructive Lung Disease; Radioprotection; Tumor Suppression/Bone Marrow Transplantation; and Stroke. These therapeutic focus areas were selected based upon preliminary data developed using Aeolus catalytic antioxidant compounds.
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' Quarterly Report on Form 10-Q for the quarter ended December 31, 2005. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Please visit our website at www.aeoluspharma.com.
Aeolus Pharmaceuticals, Inc.