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Synvista Therapeutics Posts Letter to Stockholders on Web Site
Date:9/17/2008

t of 260 patients. As a result of accumulating data on the connection between CML levels and cardiovascular outcomes and the progress of our alagebrium development program, we have begun to commercialize our CML assay. To date, a licensee has sold more than 6,000 research- use-only tests. We are preparing the kit for 510(k) submission in the first half of 2009.

THERAPEUTICS

We have initiated two Phase 2 studies with alagebrium. Alagebrium is a proposed breaker of A.G.E.s for the treatment of heart failure.

The BENEFICIAL study, which began in November 2007, is a 100-patient study in chronic heart failure (CHF) being conducted at a single site in The Netherlands. This study is designed to involve nine months of treatment and is designed to measure the effect of alagebrium on exercise tolerance in patients with CHF. The study objective is to improve maximal oxygen consumption (VO2max), which is highly correlated with an improvement in myocardial function in patients with CHF. It also examines the ability of alagebrium to breakdown A.G.E.s by tracking levels of CML. As of the time of this writing, the study is more than 50% enrolled and is on track for completion in late 2009.

The BREAK study, which enrolled the first of 160 patients in May 2008, is a randomized, double-blind, placebo-controlled study at approximately 25 U.S. sites intended to assess the effect of six months of oral treatment with 400mg (200mg twice daily) of alagebrium versus placebo in patients with diastolic heart failure. Diastolic heart failure is particularly common among people with diabetes, and our intent is that at least one-half of the subjects enrolled in this study will have diabetes. The primary efficacy measure of the BREAK 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 CML. This study also is
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