MONTVALE, N.J., Nov 05, 2007 /PRNewswire-FirstCall via COMTEX/ -- Synvista Therapeutics, Inc. (SYI) announces results of a clinical trial known as the ICARE study, being presented today at the American Heart Association's (AHA) Scientific Sessions 2007 in Orlando, Florida. The study demonstrated that supplementing Vitamin E therapy in patients with Diabetes Mellitus (DM) who had the Haptoglobin 2-2 (Hp2-2) phenotype met its pre-specified, primary endpoint of decreased cardiovascular events, leading to early termination of the four-year study after just 18 months.
"We are thrilled that Dr. Andrew P. Levy and his colleagues at the Rappaport Research Institute in the Technion Faculty of Medicine, Technion- Israel Institute of Technology, Haifa, Israel, and Clalit Health Services, Haifa and Western Galilee, Israel conducted this study to evaluate the efficacy of treating Hp2-2, DM patients with Vitamin E," said Noah Berkowitz, M.D., Ph.D., President and Chief Executive Officer of Synvista. "Vitamin E has been the subject of significant controversy in recent years, with several meta-analyses showing increased mortality for patients treated with this nutraceutical. We find it validating to identify the possibility, in a large, prospective clinical trial, that patients can test their Haptoglobin type and then receive an inexpensive therapy that has demonstrated clinical benefit. This is targeted therapy at its best. Further, we believe this study provides scientific rationale for our current development platform, which is based on targeting our oxidized lipid reducing product candidate, ALT-2074, to patients with DM who test positive for Hp2-2 with our diagnostic technology for Haptoglobin."
In the placebo-controlled ICARE study, more than 3,000 patients were tested for Haptoglobin phenotype, and 984 of these who had the Hp2-2 phenotype were randomized to receive either natural source Vitamin E (400 IU daily) or placebo. Primary endpoints of the study were non-fatal myocardial infarction (MI--heart attack), stroke and cardiovascular death. Results demonstrated a greater than 50% decrease in cardiovascular events in patients receiving Vitamin E (1.0 percent compared to 3.8 percent, p=0.004), leading to early termination of the study. Investigators determined this result to be predominantly due to a significant decrease in non-fatal myocardial infarction in the Vitamin E group.
"Our research group has postulated that the profoundly increased risk of, MI, stroke and cardiovascular death observed in DM patients with Hp2-2, established in many observational studies of more than 20,000 patients in recent years, may be a consequence of a defect in the antioxidant protection of Hp2-2," added Dr. Levy. "As a member of my group, Dr. Rabea Asleh, reported earlier today, this defect may interfere with reverse cholesterol transport. This in turn may promote a more inflamed and labile atherosclerotic plaque. It is gratifying to have had this opportunity to collaborate with Clalit Health Services, the largest health plan in Israel, in a large prospective clinical trial that provides strong support for the claim that Vitamin E can be targeted to DM patients with Hp2-2 and provide a significant clinical benefit."
About Synvista Therapeutics
Synvista Therapeutics is a biopharmaceutical company developing small molecule drugs to treat and prevent cardiovascular disease and to treat nephropathy in people with diabetes. The Company has identified several product candidates that it believes represent novel approaches to some of the largest pharmaceutical markets. The Company's portfolio includes orally bioavailable, organoselenium mimics of glutathione peroxidase. These compounds metabolize lipid peroxides and have the potential to limit myocardial damage subsequent to a myocardial infarction. The Company is developing a clinical diagnostic test, based on cardiovascular risk assessment, using Haptoglobin characterization, to identify patients at high risk for cardiovascular complications of diabetes.
Synvista Therapeutics also is developing alagebrium, a proposed breaker of AGEs for the treatment of diastolic heart failure. This disease represents a rapidly growing market of unmet medical need, particularly common among diabetic patients. Alagebrium has demonstrated relevant clinical activity in two Phase 2 clinical trials in heart failure, as well as in animal models of heart failure and nephropathy, among others. Alagebrium has been tested in approximately 1,000 patients in multiple Phase 1 and Phase 2 clinical trials, allowing Synvista Therapeutics to assemble a sizeable human safety database. For more information, please visit the Company's website at www.synvista.com.
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, the risks associated with the events described in this press release, future clinical development of Synvista Therapeutics' product candidates, and other risks identified in Synvista Therapeutics' filings with the Securities and Exchange Commission. Further information on risks faced by Synvista are detailed under the caption "Risk Factors" in Synvista Therapeutics' Annual Report on Form 10-K for the year ended December 31, 2006. These filings are available on a website maintained by the Securities and Exchange Commission at http://www.sec.gov. The information contained in this press release is accurate as of the date indicated. Actual results, events or performance may differ materially. Synvista Therapeutics 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.