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Alteon's alagebrium to be Evaluated in NIH-Funded Phase 2 Clinical Study Focused on Cardiovascular Aging
Wednesday September 27, 3:25 PM EDT
- Grant Awarded to University of Texas Southwestern
Medical Center --
-- Study Design Supports Alteon's Initiative in Diastolic Heart
Failure --
PARSIPPANY, N.J., Sept. 27, 2006 (PRIMEZONE) -- Alteon Inc. (ALT) announced today that a Phase 2 clinical study of alagebrium, a novel Advanced Glycation End-product (A.G.E.) breaker, will be conducted at the University of Texas Southwestern Medical Center at Dallas as part of a five-year $3.1 million National Institutes of Health (NIH) grant. alagebrium will be studied as a novel intervention when combined with exercise training with the goal of significantly improving cardiac compliance and diastolic function in aged individuals. Demonstrating an ability of alagebrium to reverse deficits attributable to aging and sedentary lifestyle would be supportive of Alteon's development efforts for alagebrium in diastolic heart failure (DHF).
"This clinical study will examine the impact of alagebrium on cardiac compliance (stiffness), and function, expanding the observations of as yet unpublished preclinical studies in animal models of age-related cardiac dysfunction," said Noah Berkowitz, M.D., Ph.D., Alteon's President and CEO. "As the endpoints in our DHF program will include an assessment of exercise tolerance, this new study is highly complementary to our desired approval pathway for alagebrium in DHF."
The study is expected to be initiated during the first half of 2007, and is expected to enroll approximately 60 patients. Benjamin D. Levine, M.D., the Principal Investigator, is Director of the Institute for Exercise and Environmental Medicine at Presbyterian Hospital, Professor of Internal Medicine at UT Southwestern.
DHF is characterized by a non-compliant ventricle. The UT Southwestern researchers hypothesize that A.G.E. crosslinks must be disrupted before a meaningful improvement in compliance can occur with exercise training. "With alagebrium and exercise, we hope to challenge the inevitable consequence of cardiovascular aging associated with a sedentary lifestyle," said Dr. Levine.
Phase 2 clinical data on alagebrium presented at the American Heart Association (AHA) meeting in November 2005, demonstrated the ability of alagebrium to improve overall cardiac function, including measures of systolic and diastolic function. In those studies, alagebrium also demonstrated the ability to significantly reduce left ventricular mass and improve cardiac structure and function in patients with chronic heart failure (Thohan, V. et al. AHA, 2005). alagebrium has been tested in multiple Phase 1 and Phase 2 clinical trials in approximately 1,000 patients, which represents a sizeable human safety database. In recent preclinical studies, treatment with alagebrium in a rat model of aging-associated cardiovascular dysfunction indicated effects similar and additive to that of exercise in reversing age-related cardiac dysfunction.
Chronic physical inactivity contributes to the deaths of nearly 1 in 10 Americans, and may directly or indirectly lead to 250,000 premature deaths per year in the United States. For seniors, the single most common life-threatening disease is chronic heart failure, accounting for 700,000 hospital admissions per year at more than $20 billion in healthcare costs. For the majority of these patients, abnormalities of diastolic function appear to play a critical role in the pathophysiology of this disease.
About Alteon
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. This disease 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 trials. The Company also has rights to a diagnostic assay that identifies the 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, including the effect of the Phase 2 exercise study on the future clinical development of, and regulatory approval processes for, alagebrium, are forward-looking statements that involve risks and uncertainties. These risks and uncertainties include, but are not limited to, those relating to Alteon's ability to obtain sufficient funding to continue as a going concern and to continue the development of alagebrium and ALT-2074, 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, 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.
Investor Relations
(201) 818-5537
