Synvista Therapeutics Announces Initiation of the BREAK Study of Alagebrium for Diastolic Hea...( Company Now Has Four ...)

Company Now Has Four Phase 2 Trials Underway

MONTVALE, N.J., May 13 /PRNewswire-FirstCall/ -- Synvista Therapeutics, Inc. (Amex: SYI) has dosed the first patient in a 160-patient Phase 2 study of alagebrium in patients with diastolic heart failure. BREAK (Beginning a Randomized Evaluation of the A.G.E. [Advanced Glycation End Product] Breaker Alagebrium in Diastolic Heart Failure) is a randomized, double-blind, placebo controlled study to assess the effect of six months of oral treatment with 400mg (200mg twice daily) alagebrium versus placebo in patients diagnosed with diastolic heart failure as verified by echocardiography. The trial will ultimately enroll 80 patients per cohort and be conducted in as many as 25 centers in the United States. Investigators intend that at least half of the study subjects will have diabetes mellitus. The primary efficacy measure of the study is improvement of exercise tolerance as assessed by the six-minute walk test, an accepted regulatory endpoint. In addition, there will be a number of secondary and tertiary measurements including the effect on carboxymethyllysine (CML), a biomarker of A.G.E., against which Synvista has developed a proprietary monoclonal antibody, 4G9, which can be developed into an in-vitro diagnostic test.

"This is a very important study for alagebrium. By looking at the results of the BREAK study along with our BENEFICIAL study in systolic heart failure, we will have a better understanding of the role of A.G.E.s in heart failure," said Noah Berkowitz, M.D., Ph.D., President and Chief Executive Officer of Synvista Therapeutics, developer of alagebrium. "Based on what we learn from these studies, there is immense potential to expand the scope of treatment modal
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