Synvista Therapeutics Announces Progress in Phase 2 Clinical Trial Program for Alagebrium
January 12 2009 - 7:30AM
PR Newswire (US)
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
http://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. DATASOURCE: Synvista
Therapeutics, Inc. CONTACT: Company Contact: Synvista Therapeutics,
Inc., +1-201-934-5000, ; or Investor/Media Relations Contact: Jules
Abraham of Lippert/Heilshorn & Associates, +1-212-838-3777, Web
Site: http://www.synvista.com/
Copyright