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News Release - September 11, 2006
New Alteon Management Focuses its Development of Alagebrium on Heart Failure with Preserved Ejection Fraction, also Known as Diastolic Heart FailureNew Publications Identify the Pressing Need for Treatment of Diastolic Heart Failure
PARSIPPANY, N.J., Sept. 11 (HSMN NewsFeed) -- The new management of Alteon Inc. (Amex: ALT ), to further validate the Company's newly focused development of alagebrium on diastolic heart failure, highlights the recent publication of several articles that illustrate the medical community's increasing recognition of this form of heart failure. "A strong body of preclinical and clinical evidence supports our advancement of alagebrium's clinical development in diastolic heart failure," said Malcolm MacNab, M.D., Ph.D., Vice President, Clinical Development of Alteon. "The recent focus on this patient population by key opinion leaders further encourages our aggressive pursuit of this disease characterized by an unmet medical need."
The Company will be presenting its rationale for the development of alagebrium in diastolic heart failure at an invited talk entitled "Novel Pathways That Modulate Myocardial Fibrosis" at a Symposium entitled "Modulating the Matrix," at the 10th Annual Meeting of the Heart Failure Society of America (www.hfsa.org) on September 12, 2006 in Seattle, Washington.
The highlighted articles discussing diastolic heart failure appeared in a recent issue of the New England Journal of Medicine (NEJM)(1,2) An editorial in the NEJM describes the syndrome known as diastolic heart failure and reviews the articles which make the following key points(3):
- Diastolic heart failure (DHF) is epidemic as observed by an increase in
prevalence among heart failure patients in three successive five year
periods (38%, 47% and 54%).
- Patients with DHF have significant one year (22-29%) and five year (65%)
mortality rates and could benefit from effective treatment strategies.
- To date, no agents have been approved by regulatory agencies for
improving survival in DHF patients.
- Patients with DHF are typically older, female and heavier. They may
account for 50% of all heart failure hospitalizations.
- There are two distinguishable forms of heart failure. Systolic heart failure typically evolves when heart tissue dies after a heart attack. As a consequence, the heart pumps ineffectively and a smaller fraction of blood is ejected with each contraction (decreased ejection fraction). In contrast, (DHF) typically results from aging, diabetes or chronic hypertension. In DHF, the heart becomes stiff, fails to relax and fills inadequately; the fraction of ejected blood is normal.
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.
The Company's lead drug candidate, alagebrium, is a product of its drug discovery and development program. Alagebrium has demonstrated potential efficacy in two clinical trials in heart failure, as well as in animal models of heart failure and nephropathy, among others. It has been tested in approximately 1,000 patients in a number of Phase 1 and Phase 2 clinical trials. The Company's goal is to develop alagebrium in diastolic heart failure. This disease represents a rapidly growing market of unmet medical need, particularly common among diabetic patients, and alagebrium has demonstrated relevant clinical activity in two Phase 2 clinical trials.
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 are forward-looking statements that involve risks and uncertainties including, but not limited to, those relating to Alteon's ability to obtain sufficient funding to continue as a going concern and 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.
(1) Owan, TE, et al Trends in Prevalence and Outcome of Heart Failure with Preserved Ejection Fraction NEJM (2006) 355(3): 251-259
(2) Bhatia, R. S. Outcome of Heart Failure with Preserved Ejection Fraction in a Population-Based Study. NEJM (2006) 355(3): 260-269
(3) Aurigemma, G.P. Diastolic Heart Failure - A Common and Lethal Condition by Any Name. NEJM (2006) 355(3): 308-310
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