Synvista Therapeutics Announces Progress in Phase 2 Clinical Trial Program for Alagebrium

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Mon Jan 12, 2009 8:30am EST

Synvista Therapeutics Announces Progress in Phase 2 Clinical Trial Program for
Alagebrium

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." 

About Alagebrium
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.

Company Contact: Synvista Therapeutics, Inc., +1-201-934-5000,
ir@synvista.com; or Investor/Media Relations Contact: Jules Abraham of
Lippert/Heilshorn & Associates, +1-212-838-3777, jabraham@lhai.com
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