Synvista Therapeutics Announces Initiation of Phase 2 Study With Alagebrium for Chronic Hea...( MONTVALE N.J. Nov. 12 /- Synvista...),Health

MONTVALE, N.J., Nov. 12 /PRNewswire-FirstCall/ -- Synvista Therapeutics, Inc. (AMEX: SYI) announced today, dosing of the first patient in BENEFICIAL, a 100-patient Phase 2 clinical trial of alagebrium (ALT-711), a novel compound designed to act as an Advanced Glycation End-product (AGE)-cross-link breaker, in patients with chronic heart failure (CHF). The BENEFICIAL study (Double- blind, placebo-controlled, randomized trial evaluating the efficacy and safety of alagebrium) is designed to measure the effect of alagebrium on exercise tolerance in patients with CHF. The Company plans to use the experience and results of this study to guide development of its Phase 3 program for alagebrium in CHF. The single-site Phase 2 trial is being conducted at the University Medical Centre Groningen, The Netherlands and the principal investigator is Adriaan A. Voors, M.D., Associate Professor of Cardiology.

The objective of the BENEFICIAL study is to improve maximal oxygen consumption (VO2max), which is highly correlated with an improvement in myocardial function in patients with CHF. Diastolic and systolic function will be measured by tissue velocity imaging with echocardiography. The ability of alagebrium to break down AGEs will also be measured by tracking levels of carboxy-methyllysine (an AGE) in the skin using an auto-fluorescence device.

"Alagebrium is the first orally active AGE-cross-link breaker that has been evaluated in preclinical and clinical studies, and studies using animal models of diabetes and aging have demonstrated its effect in reversing cardiac stiffening," said Dr. Voors. "We are encouraged by the potential that alagebrium has demonstrated in our preclinical models, and are aggressively pursuing cli
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