Press Release Source: Alteon Inc.
Alteon's ALT-711 Reduces Left Ventricular Mass in Diamond Trial Patients
Tuesday January 21, 8:15 am ET
- Positive Results from Preliminary Analyses Support Drug's Potential in DHF -
RAMSEY, N.J., Jan. 21 /PRNewswire-FirstCall/ -- Alteon Inc. (Amex: ALT - News) today announced positive results from a preliminary analysis of the Phase IIa DIAMOND clinical trial evaluating the activity of ALT-711 in diastolic heart failure (DHF) patients. The DIAMOND trial is ongoing, and additional analyses of the data are being conducted.
Patients who received ALT-711 for 16 weeks experienced a statistically significant reduction in left ventricular mass, in a preliminary analysis of the first 17 patients in the DIAMOND trial. DIAMOND patients also had a marked improvement in left ventricular diastolic filling. Additionally, the drug had a positive effect on patients' quality of life, as measured by a well-established heart failure/quality of life questionnaire. Measurements of exercise tolerance and aortic distensibility proved to be more variable than anticipated for a study of this size and were not reportable.
"These results have importance because DHF is the most common form of heart failure in the elderly population. To date, there is no proven specific therapy," said Dalane W. Kitzman, M.D., Associate Professor of Medicine and Cardiology at Wake Forest University Baptist Medical Center, and an investigator in the trial. "Though this was a small pilot study, these data suggest that ALT-711 may be useful in this disorder." Dr. Kitzman's research, recently published in the Journal of the American Medical Association and the Annals of Internal Medicine, has been critical to the characterization and identification of diastolic heart failure as a more common condition than previously thought, particularly in people aged 65 and older, and especially in women.(1,2)
DHF is a poorly treated medical condition that is characterized by the inability of the heart to relax properly and fill with blood, due to stiffening of the heart and subsequent impaired relaxation of the left ventricle. Diastolic dysfunction is estimated to account for 30-50% of all heart failure cases, which total nearly 5 million cases in the U.S. alone.
"The results of the DIAMOND trial are important to Alteon because we have seen another meaningful signal of ALT-711's beneficial effect in cardiovascular disease, and offer additional guidance for the clinical program that lies ahead," said Kenneth I. Moch, President and Chief Executive Officer of Alteon. "These findings are consistent with previous preclinical work which demonstrated ALT-711's ability to remodel the diseased heart."
The DIAMOND (Distensibility Improvement and Remodeling in Diastolic Heart Failure) study was conducted at Wake Forest University Baptist Medical Center and the Medical University of South Carolina in patients at least 60 years of age with isolated DHF. In the DIAMOND trial, twenty-three patients received 210 mg of ALT-711 twice daily on an open-label, outpatient basis for 16 weeks in addition to their current medications, which included ACE inhibitors or angiotensin II antagonists, beta-blockers and diuretics. Primary endpoints included changes in exercise tolerance and aortic stiffness; effects on left ventricular hypertrophy, diastolic filling and quality of life (QOL) were also assessed.
"We look forward to the presentation of the detailed data from the DIAMOND trial in an appropriate scientific forum and journal," said Moch, "and to reporting results from the ongoing Phase IIb SAPPHIRE and SILVER trials of ALT-711 in systolic hypertension later this year."
ALT-711 offers promise as a novel therapy for DHF because currently available therapies do not specifically target the stiffening heart and vessel walls caused by pathological glucose-protein matrixes called Advanced Glycosylation End-product (A.G.E.) Crosslinks. The formation of A.G.E. Crosslinks is a natural part of the aging process that can lead to stiffening and loss of function in tissues, organs and vessels including the heart and large arteries. In previous human clinical testing, ALT-711 has shown the ability to restore elasticity to blood vessel walls by cleaving A.G.E. Crosslinks.(3) Additionally, in several preclinical studies ALT-711 has been shown to normalize the thickening of the left ventricle and remodel the heart.(4)
ALT-711 is currently in two additional human clinical trials. The Phase IIb SAPPHIRE and SILVER trials have enrolled over 760 patients in order to evaluate the compound's effectiveness in patients with elevated systolic blood pressure without or with enlargement of the left ventricle of the heart. Like diastolic heart failure, systolic hypertension results from age-related or diabetes-related stiffening of the cardiovascular system, and is a key factor in coronary heart disease in individuals over the age of 50.
Alteon Conference Call
Alteon is holding an analyst/investor conference call today, January 21, 2003, at 2:00 PM, Eastern Time. To access this call live, please dial 1-800-915-4836. Callers outside of the United States, please call +973-317-5319. This call will be archived on the Company's website at alteon.com and will be rebroadcast until January 28, 2003 at 11:59 PM, at 1-800-428-6051, passcode 283288. Callers outside of the United States, please call +973-709-2089, passcode 283288.
About Alteon
Alteon is developing several new classes of drugs that reverse or slow down diseases of aging and complications of diabetes. These compounds have an impact on a fundamental pathological process caused by protein-glucose complexes called Advanced Glycosylation 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, organs and vessels and have been shown to be a causative factor in many age-related diseases and diabetic complications. Alteon is initially developing therapies for cardiovascular and kidney diseases in older or diabetic individuals.
Alteon has created a library of novel classes of compounds targeting the A.G.E. Pathway. These include A.G.E. Crosslink Breakers, A.G.E. Formation Inhibitors and Glucose Lowering Agents. The Company's lead A.G.E. Crosslink Breaker, ALT-711, has demonstrated positive results in two Phase IIa trials, in cardiovascular compliance and in diastolic heart failure. The compound is currently being evaluated in the Phase IIb SAPPHIRE clinical trial focused on patients with systolic hypertension and the Phase IIb SILVER trial in patients with systolic hypertension and left ventricular hypertrophy, for which data will be reported concurrently about mid-year. Other A.G.E. compounds are being evaluated for skin aging and additional indications. For more information on Alteon, visit the Company's website at alteon.com .
(1) Kitzman DW, Little WC, Brubaker PH, Anderson RT, Hundley WG, et al.
Pathophysiological characterization of isolated diastolic heart failure in comparison to systolic heart failure. Journal of the American Medical Association 2002; 288(17): 2144-50.
(2) Gottdiener JS, McClelland RL, Marshall R, Shemanski L, Furberg CD, Kitzman DW, et al. Outcome of congestive heart failure in elderly persons: influence of left ventricular systolic function. The Cardiovascular Health Study. Annals of Internal Medicine 2002;
137(8): 631-639.
(3) Kass DA, Shapiro EP, Kawaguchi M, Capriotti AR, Scuteri A, deGroof RC, Lakatta EG. Improved arterial compliance by a novel advanced glycation end-product crosslink breaker. Circulation 2001;104:1464-70, Rapid Track Publication.
(4) Veronesi M, Adam AG, Raij L. Abstract - ALT-711, A collagen cross-link breaker, decreases myocardial fibrosis and improves endothelial dysfunction in hypertensive Dahl salt rats. American Heart Association 55th Annual Fall Conference and Scientific Sessions of the Council for High Blood Pressure Research, September
2001.
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.
Source: Alteon Inc.
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