Alagebrium Demonstrates Cardiovascular Activity in Recently Published Report Indicating Potential Wide-Ranging Benefits in Cardiovascular Diseases
Alagebrium Modifies Biomarkers Relating to Inflammation, Matrix Turnover and Endothelial Function Vascular Reactivity Observed After Twice Daily Dosing
PARSIPPANY, N.J., February 15, 2007 (PRIME NEWSWIRE) -- Alteon Inc. (AMEX:ALT) announced today that data demonstrating the ability of its compound, alagebrium, to augment flow-mediated dilation (FMD) is the subject of a paper published in the March 2007, Volume 25, No. 3 issue of the Journal of Hypertension, by Susan Zieman, M.D, Ph.D., Assistant Professor, Department of Medicine (Cardiology), and colleagues from Johns Hopkins School of Medicine. The paper, describing an investigator-sponsored Phase 2 clinical trial, indicates that alagebrium can induce changes in flow-mediated dilation and a variety of biomarkers related to inflammation, matrix turnover and endothelial function. The Company believes that this pragmatic demonstration of alagebrium's biological activity in human clinical subjects using a collection of well-validated biomarkers, is supportive of the Company's plans to advance alagebrium's development in cardiac and vascular mediated disease.
FMD is thought to be a good test for the "health" and responsiveness of blood vessels. Investigators can block blood flow in an artery by applying pressure and then they can measure the increase in blood flow upon alleviation of the pressure. In Dr. Zieman's study, patients with isolated systolic hypertension, received alagebrium at a dose of 210 mg twice daily and were analyzed with baseline and post-treatment follow-up. FMD increased from 4.6 plus or minus 1.1 to 7.1 plus or minus 1.1% with alagebrium (P is less than 0.05), and the increase was unrelated to altered shear stress or regional arterial distensibility. The increase in FMD correlated with a decrease in markers of collagen synthesis, p-selectin and intracellular cell adhesion molecule (all P is less than 0.05), suggesting an anti-inflammatory mediated mechanism for the increase in FMD. The ability of alagebrium to decrease markers associated with inflammation and matrix synthesis may have wide ranging beneficial implications for cardiovascular health.
"We congratulate Dr. Zieman and her colleagues for producing exceptional translational work that addresses the biology underlying alagebrium's effect on cardiovascular physiology," said Noah Berkowitz, M.D., Ph.D., President and Chief Executive Officer of Alteon. "We believe that results such as these, demonstrating alagebrium's anti-inflammatory and anti-fibrotic effects on vascular reactivity make a strong mechanistic case for advancing alagebrium's development in vascular and cardiac diseases such as diabetic nephropathy and diastolic heart failure."
Alteon is a product-based biopharmaceutical company engaged in the development of small molecule drugs to treat and prevent the inflammatory aspects of cardiovascular disease and diabetes. The Company has identified several promising product candidates that it believes represent novel approaches to some of the largest pharmaceutical markets.
Alagebrium, a product of Alteon's drug discovery and development program, is being developed for the treatment of diastolic heart failure and diabetic nephropathy. Diastolic heart failure represents a rapidly growing market of unmet medical need, particularly common among diabetic patients. Alagebrium has demonstrated relevant clinical activity in two Phase 2 clinical trials in heart failure, as well as in animal models of heart failure and nephropathy, among others. Alagebrium has been tested in approximately 1,000 patients in multiple Phase 1 and Phase 2 clinical trials, which represents a sizeable human safety database.
The Company's portfolio also includes orally bioavailable, organoselenium mimics of glutathione peroxidase that metabolize lipid peroxides and have the potential to limit myocardial damage subsequent to a myocardial infarction. Alteon's lead compound for that program, ALT-2074, is in Phase 2 clinical development. The Company also has rights to a diagnostic assay that identifies a large subset of diabetic patients at highest risk for cardiovascular complications, because of a defect in oxidized lipid metabolism that results in increased cardiovascular inflammation. For more detailed information about Alteon's research and development, please visit Alteon's website at www.alteon.com.
Any statements contained in this press release that relate to future plans, events or performance are forward-looking statements that involve risks and uncertainties including, but not limited to, the risk that the potential preferred stock financing described in this press release will not be completed in a timely manner or at all, and other risks identified in Alteon's filings with the Securities and Exchange Commission. Further information on risks faced by Alteon are detailed under the caption "Risk Factors" in Alteon's Annual Report on Form 10-K for the year ended December 31, 2005 and in its subsequent Quarterly Reports on Form 10-Q. These filings are available on a website maintained by the Securities and Exchange Commission at http://www.sec.gov. The information contained in this press release is accurate as of the date indicated. Actual results, events or performance may differ materially. Alteon undertakes no obligation to publicly release the result of any revision to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
CONTACT: Alteon Inc.
Posted: February 2007