PARSIPPANY, N.J., May 23 /PRNewswire-FirstCall/ -- Alteon Inc. announced today that positive data from the initial group of patients in a Phase 2a study on endothelial function and vascular compliance were presented recently at two scientific forums: The American Geriatrics Society 2005 Annual Scientific Meeting and the 11th Annual Scientific Session of The Society of Geriatric Cardiology. The study, conducted at Johns Hopkins University School of Medicine (JHU), demonstrated that the company’s investigational drug, alagebrium, increases arterial elasticity through the breaking of A.G.E. crosslinks and improves endothelial function. As central arterial stiffening and endothelial dysfunction are both risk factors for cardiovascular disease, the authors conclude that these effects may favorably modify cardiovascular risk in older hypertensive subjects.
The study, presented under the titles, “Treatment with Alagebrium, a Collagen Glycation Crosslink Breaker, Reduces Carotid Pressure Augmentation in Older Subjects with Isolated Systolic Hypertension,” and “The Effect of Vascular Stiffness on Endothelial Dysfunction,” was conducted under grants from the National Heart, Lung and Blood Institute and the Society of Geriatric Cardiology/Association of Subspecialty Professors by a JHU research team led by Susan Zieman, M.D. and David Kass, M.D. Male or female patients 50 years of age or greater (n=13), with systolic hypertension (systolic blood pressure > 140 mm Hg and a diastolic blood pressure < / = 95 mm Hg) received 2 weeks of placebo run-in dosing followed by 210 mg of alagebrium twice daily for 8 weeks. The primary purpose of the trial was to determine whether increasing arterial elasticity by breaking A.G.E. crosslinks improves endothelial function as assessed by evaluating vessel distensibility and flow-mediated dilation, a dynamic test of endothelial cell function. Results from the pilot study showed that, when compared with baseline, carotid augmentation index, a measure of vascular stiffness, decreased by 37.3% and augmented pressure declined 41% (p<0.001). Brachial systolic and diastolic blood pressures (BP) did not significantly change in this patient population at this dose. Alagebrium therapy also was associated with a marked increase in flow-mediated dilation or FMD (4.6% to 7.1%, p=0.05), a measure of endothelial function. Further studies are being conducted to determine whether these two findings are inter-related or if alagebrium is associated with two independent beneficial effects.
“These results indicate the ability of alagebrium to improve central vascular distensibility and endothelial function, which may lower the risk of cardiovascular disease in older adults,” said Dr. Zieman.
“These data further demonstrate the promising effects of alagebrium on the cardiovascular system,” added Kenneth I. Moch, President and Chief Executive Officer, “and are consistent with the positive data on alagebrium that we have seen to date in the rapid therapeutic remodeling of stiffened tissues and organs.”
The endothelium, a single-cell layer lining of the arteries that is an interface between the blood and arterial wall, is impaired in many cardiovascular conditions. Endothelial damage, and the resulting inability of smaller vessels to react to changes in blood pressure, can be a predictor of present and future cardiovascular disease. Evidence suggests that when arteries become stiffer, endothelial function is worsened even when the endothelial cells themselves are normal. The loss of vascular tone due to the interaction between arterial stiffening and endothelial function may be important in explaining why stiff arteries are a major risk factor for cardiovascular disease. Alagebrium is the first compound in advanced clinical trials to demonstrate the potential to reverse age-related cardiovascular disease and restore flexibility and function to the arteries and heart by cleaving pathological protein-glucose structures called Advanced Glycation End-product (A.G.E.) Crosslinks.
About Alteon
Alteon is developing several new classes of drugs that have shown the potential to reverse or slow down diseases of aging and complications of diabetes. These compounds appear to have an impact on a fundamental pathological process caused by the progressive formation of protein- carbohydrate complexes called Advanced Glycation End-products (A.G.E.s). The formation and crosslinking of A.G.E.s lead to a loss of flexibility and function in body tissues and organs and have been shown to be a causative factor in many age-related diseases and diabetic complications. Alteon has created a library of novel classes of compounds targeting the A.G.E. pathway. Alteon’s lead compound alagebrium chloride (formerly ALT-711), the only A.G.E. Crosslink Breaker in advanced human testing, has shown promising results in several Phase 2 trials and is being developed for systolic hypertension, heart failure and erectile dysfunction.
In February 2005, Alteon voluntarily and temporarily suspended enrollment of new patients into the Company’s ongoing alagebrium clinical studies pending receipt of additional pre-clinical toxicity data. In May 2005, the Company announced encouraging interim results from these ongoing toxicity tests, and announced its intention to conduct an interim analysis of data from the SPECTRA trial; the results of both are expected approximately mid-year 2005. The Company expects that decisions regarding resumption of enrollment into each of the trials will be made at that time.
For more detailed information about alagebrium, please visit the research and development section of the Alteon website, http://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, those relating to technology and product development (including the possibility that early clinical trial results may not be predictive of results that will be obtained in large-scale testing or that any clinical trials will not demonstrate sufficient safety and efficacy to obtain requisite approvals or will not result in marketable products), regulatory approval processes, intellectual property rights and litigation, competitive products, ability to obtain financing, and other risks identified in Alteon’s filings with the Securities and Exchange Commission. 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.
Alteon Inc.
CONTACT: Susan M. Pietropaolo, Director, Corporate Communications &Investor Relations of Alteon Inc., +1-201-818-5537, orspietropaolo@alteon.com
Web site: http://www.alteonpharma.com/