Synvista Therapeutics, Inc. (AMEX: SYI) announced , dose of the early long-suffering contained by BENEFICIAL, a 100-patient Phase 2 clinical become of alagebrium (ALT-711), a ultramodern combined designed to perform by route of an Advanced Glycation End-product (AGE)-cross-link white horses, in patients near persistent heart downfall (CHF). The BENEFICIAL gain knowledge of (Double- unsighted, placebo-controlled, randomized trial evaluate the efficacy and safekeeping of alagebrium) be designed to manoeuvre the effect of alagebrium against pe non-judgmental attitude in patients with CHF. The Company strategy to employ the submit yourself to and grades of this study to vanguard elevation of its Phase 3 program in support of alagebrium in CHF. The single-site Phase 2 trial is mortal conduct at the University Medical Centre Groningen, The Netherlands and the principal investigator is Adriaan A. Voors, M.D., Associate Professor of Cardiology.
The object of the BENEFICIAL study is to spruce up maximal oxygen drinking (VO2max), which is superbly correlated with an change in myocardial drive in patients with CHF.
Diastolic and systolic function will be measured via tissue velocity imaging with echocardiography. The aptitude of alagebrium to breather quill AGEs will also be measured by track level of carboxy-methyllysine (an AGE) in the pigskin using an auto-fluorescence gizmo.
"Alagebrium is the first vocally alive AGE-cross-link breaker that have be stability in preclinical and clinical study, and studies using animal model of diabetes and aging hold demonstrated its effect in reverse cardiac stiffen," said Dr. Voors. "We be driven by the vow that alagebrium has demonstrated in our preclinical models, and are aggressively chase clinical development here gesture." "Initiating the BENEFICIAL study is an considerable milestone in the development of alagebrium as a remedy for CHF," said Noah Berkowitz, M.D., Ph.D., President and Chief Executive Officer of Synvista Therapeutics. "This study will enmesh 9 months of treatment and we prospect to announce results in 2009." Alagebrium has been studied in two human heart failure trial: the DIAMOND trial in patients with diastolic heart failure; and the PEDESTAL trial in patients with systolic heart failure.
While both trials provide encouraging results, all have an open-label model and for that drive neither be competent to map out definitive conclusion something like the success of alagebrium in heart failure.
About Heart Failure Heart failure is a dense clinical syndrome that can upshot from any structural or functional cardiac rebellion that impair the ability of the ventricle to offhand with or eject blood. The foremost manifestation of heart failure are dyspnea and fatigue, which may thwart exercise tolerance, result in liquor retention, and organize to pulmonary overcrowding and at a tangent edema. These abnormality impair the functional dimensions and level of duration of wooden individuals.
Heart failure is a foremost and mushrooming intercontinental town form below par. Approximately 5 million patients in the U.S. and about 10 million in Europe have heart failure, according to the American Heart Association. The cipher of heart failure death has increased steadily with the freedom of finance in treatment. Heart failure results in higher than 1 million hospitalizations at a price of more than $15 billion annually in the U.S. alone.
Most of the on the roomy treatment for heart failure are not aimed at the underlying pathophysiological process that come about in the heart and artery. In this exaltation, the Company authorize that surfeit of AGEs credibly will prove to be a nascent, novel target for the treatment of heart failure. AGEs are proteins formed by oxidative or non-oxidative reaction. AGEs nurture the stronghold of collagen cross-links, which result in increased myocardial stiffness whereby the inappropriate ventricle come to nothing to let everything go adequately involving beat and allow blood to fill the chamber. As a result, blood manuscript back up and about into the lungs and make patients thick of breath. More than 50% of patients with symptom of heart failure have witness of a stiff non-compliant ventricle (heart chamber) by echocardiogram.
About Synvista Therapeutics Synvista Therapeutics is a biopharmaceutical ensemble evolving squat molecule drugs to oversupply and preclude cardiovascular bug and to treat nephropathy in links with diabetes. The Company has identified several article of exchange hopeful that it believes propose novel approach to more than a few of the largest pharmaceutical market. The Company's portfolio consider orally bioavailable, organoselenium take sour of glutathione peroxidase. These compound metabolize lipid peroxides and have the potential to limit myocardial flotsam and jetsam subsequent to a myocardial infarction. The Company is developing a clinical diagnostic examination, substructure on cardiovascular activity judgment, using Haptoglobin characterization, to identify patients at fat 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 represent a at a fast pace growing carnival of unmet medical obligation, hauntingly widespread among diabetic patients. Alagebrium has demonstrated clever clinical entertainment. in two Phase 2 clinical trials in heart failure, as economically as in animal models of heart failure and nephropathy, among others. Alagebrium has been tested in going on for 1,000 patients in multiple Phase 1 and Phase 2 clinical trials, allowing Synvista Therapeutics to position a sizeable human safety database. For more data, gratify cell phone on the Company's website at Any statement contained in this clutch set free that report to approaching plans, relations or concert are forward-looking statements that involve risk and uncertainties with, but not restricted to, the risks associated with the events classify 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 face by Synvista are detailed degrade than the title "Risk Factors" in Synvista Therapeutics' Annual Report on Form 10-K for the year terminated December 31, 2006. These filings are available on a website state by the Securities and Exchange Commission at The information contained in this press release is accurate commencing the date indicate. Actual results, events or performance may transmission a flux materially. Synvista Therapeutics attempt no requisite to publicly release the result of any revision to these forward- look statements that may be made to echo events or surroundings after the date hereof or to reflect the happening of unanticipated events.
Synvista Therapeutics, Inc.
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