Synvista Therapeutics Reports Results of Three Phase 2 Clinical Trials of SYI-2074 in Diabetic Patients with Cardiovascul... ( We are choosing not to advance the S...)

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Synvista Therapeutics Reports Results of Three Phase 2 Clinical Trials of SYI-2074 in Diabetic Patients with Cardiovascular Disease

Date:6/6/2008

"We are choosing not to advance the SYI-2074 program in the very competitive area of acute coronary syndrome at this time, in the absence of stronger surrogate markers of efficacy," said Noah Berkowitz, M.D., Ph.D., President and Chief Executive Officer of Synvista Therapeutics.

"We are pleased to have established correlation between increased plasma isoprostanes and haptoglobin type, as we believe this further validates the biology underlying our proprietary haptoglobin test. Haptoglobin typing has been used in studies that have evaluated more than 20,000 patients, and researchers have demonstrated that Hp2-2 patients with diabetes are at high risk for myocardial infarction, heart failure and stroke. To that end, our diagnostic test is on track to be available commercially in the second quarter of 2009. Further, we are planning to submit a kit measuring CML (carboxy-methyl-lysine), another increasingly well-validated, cardiovascular biomarker, for FDA marketing clearance in 2009," Dr. Berkowitz continued. "We are also moving forward with our alagebrium program, which began enrollment last month in a Phase 2 study for diastolic heart failure in Haptoglobin 2-2 diabetic patients, which complements a second Phase 2 study in systolic heart failure, begun last November and almost half enrolled."

About the Studies

Trial 201 was a Phase 2, placebo-controlled, dose-escalation study in which patients with diabetes and Hp2-2 were given SYI-2074 at 20, 40 or 80mg or placebo three times daily for 28 days. The study evaluated the impact of these doses on inflammatory biomarkers, and the quality and quantity of their cholesterol. Results found that SYI-2074 demonstrated improvement in some but not all of these biomarkers.

Trial 201a was a Phase 2, placebo-controlled sub-study of Trial 201. Patients with diabetes, meeting enrollment criteria for Trial 201 were tested for haptoglobin type. Patients with Hp2-2 or Hp1-1 were evaluated for baseline leve
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