MONTVALE, N.J., Jan. 12 /PRNewswire-FirstCall/ -- Synvista Therapeutics, Inc. (NYSE Alternext US: SYI) has completed enrollment of its BENEFICIAL study, a Phase 2 double-blind, placebo-controlled, randomized trial of the Company's compound alagebrium. The study is designed to measure the effect of alagebrium on exercise tolerance in patients with chronic systolic heart failure. In addition, the Company anticipates completing enrollment of its BREAK (Beginning a Randomized Evaluation of the A.G.E. [Advanced Glycation End Product] Breaker Alagebrium in Diastolic Heart Failure) study in the First Quarter of 2009. BREAK, a randomized, double-blind, placebo controlled study, evaluates whether alagebrium (200mg twice daily) can improve exercise tolerance, as measured by the 6-minute walk test, in patients diagnosed with diastolic heart failure.
"We are extremely pleased with the progress thus far in our clinical program for alagebrium," said Noah Berkowitz, M.D., Ph.D., President and Chief Executive Officer of Synvista Therapeutics, developer of alagebrium. "Based on our dialogue with the FDA, we believe that exercise tolerance is an approvable regulatory endpoint, in patients with systolic or diastolic heart failure. Accordingly, we look forward to the timely completion of these studies which could provide proof of efficacy and a partial basis for drug approval."
Alagebrium is Synvista's clinical candidate for interfering with A.G.E.-related sclerosis and fibrosis of the heart, kidney and other tissues leading to heart failure, diabetic nephropathy and other disorders. It is a proprietary A.G.E. crosslink breaker that is designed to function unlike any previously developed pharmaceutical agents to reverse the disease states associated with age or diabetes-related stiffening of vessels, tissues and organs. Alagebrium has completed a series of single- and multiple-dose Phase 1 studies in humans and has demonstrated efficacy in heart failure in several open-label Phase 2 trials. To date approximately 1,000 patients have received alagebrium treatment and the drug continues to exhibit a clean safety profile.
About Heart Failure
Heart failure is a complex clinical syndrome that can result from any structural or functional cardiac disorder that impairs the ability of the ventricle to fill with or eject blood. The primary manifestations of heart failure are dyspnea and fatigue, which may limit exercise tolerance, result in fluid retention, and lead to pulmonary congestion and peripheral edema. These abnormalities impair the functional capacity and quality of life of affected individuals.
Heart failure is a major and growing global public health problem. Approximately 5 million patients in the U.S. and about 10 million in Europe have heart failure, according to the American Heart Association. The number of heart failure deaths has increased steadily despite advances in treatment. Heart failure results in more than 1 million hospitalizations at a cost of more than $15 billion annually in the U.S. alone.
Most of the available treatments for heart failure are not aimed at the underlying pathophysiological processes that occur in the heart itself. In this respect, the Company believes that accumulation of A.G.E.s might prove to be a promising, novel target for the treatment of heart failure. A.G.E.s are proteins formed by oxidative or non-oxidative reactions. A.G.E.s cause the formation of collagen cross-links, which result in increased myocardial stiffness whereby the stiff ventricle fails to relax adequately between beats and to allow blood to fill the chamber. As a result, blood backs up into the lungs and makes patients short of breath. More than 50% of patients with symptoms of heart failure have evidence of a stiff non-compliant ventricle (heart chamber) by echocardiogram.
About Synvista Therapeutics
Synvista Therapeutics is a biopharmaceutical company developing diagnostics and drugs to diagnose, treat and prevent cardiovascular disease in people with diabetes. The Company has developed a clinical diagnostic test for Hp2-2 Diabetes, a disease affecting almost 7 million patients in the United States. The genetic or protein form of this test can be used to identify diabetic patients at high risk for cardiovascular complications. These patients may benefit from a particular formulation of Vitamin E. The Company is also developing a kit to measure CML (carboxy-methyllysine), another potential cardiovascular risk marker.
Synvista Therapeutics is developing alagebrium, a proposed breaker of advanced glycation endproducts (A.G.E.s) for the treatment of systolic and diastolic heart failure.
For more information, please visit the Company's Web site 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, 2007. 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.
|SOURCE Synvista Therapeutics, Inc.|
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