MONTVALE, N.J., Nov. 12 /PRNewswire-FirstCall/ -- Synvista Therapeutics,
Inc. (AMEX: SYI) announced today, dosing of the first patient in BENEFICIAL, a
100-patient Phase 2 clinical trial of alagebrium (ALT-711), a novel compound
designed to act as an Advanced Glycation End-product (AGE)-cross-link breaker,
in patients with chronic heart failure (CHF). The BENEFICIAL study (Double-
blind, placebo-controlled, randomized trial evaluating the efficacy and safety
of alagebrium) is designed to measure the effect of alagebrium on exercise
tolerance in patients with CHF. The Company plans to use the experience and
results of this study to guide development of its Phase 3 program for
alagebrium in CHF. The single-site Phase 2 trial is being conducted at the
University Medical Centre Groningen, The Netherlands and the principal
investigator is Adriaan A. Voors, M.D., Associate Professor of Cardiology.
The objective of the BENEFICIAL study is to improve maximal oxygen
consumption (VO2max), which is highly correlated with an improvement in
myocardial function in patients with CHF. Diastolic and systolic function
will be measured by tissue velocity imaging with echocardiography. The
ability of alagebrium to break down AGEs will also be measured by tracking
levels of carboxy-methyllysine (an AGE) in the skin using an auto-fluorescence
"Alagebrium is the first orally active AGE-cross-link breaker that has
been evaluated in preclinical and clinical studies, and studies using animal
models of diabetes and aging have demonstrated its effect in reversing cardiac
stiffening," said Dr. Voors. "We are encouraged by the potential that
alagebrium has demonstrated in our preclinical models, and are aggressively
pursuing clinical development in this indication."
"Initiating the BENEFICIAL study is an important milestone in the
development of alagebrium as a treatment for CHF," said Noah Berkowitz, M.D.,
Ph.D., President and Chief Executive Officer of Synvista Therapeutics. "This
study will involve 9 months of treatment and we hope to announce results in
Alagebrium has been studied in two human heart failure trials: the DIAMOND
trial in patients with diastolic heart failure; and the PEDESTAL trial in
patients with systolic heart failure. While both trials provided encouraging
results, each had an open-label design and thus neither was able to draw
definitive conclusions about the effectiveness of alagebrium in heart failure.
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
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 and blood
vessels. In this respect, the Company believes that accumulation of AGEs might
prove to be a promising, novel target for the treatment of heart failure. AGEs
are proteins formed by oxidative or non-oxidative reactions. AGEs cause the
formation of collagen cross-links, which result in increased myocardial
stiffness whereby the stiff ventricle fails to relax adequately between beats
and allow blood to fill the chamber. As a result, blood volume 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 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.
SOURCE Synvista Therapeutics, Inc.
/CONTACT: Company, Synvista Therapeutics, Inc., +1-201-934-5000,
email@example.com; Investor Relations, Emmanuelle Ferrer, firstname.lastname@example.org, or
Kim Sutton Golodetz, email@example.com, both of Lippert-Heilshorn &
/Web site: http://www.synvista.com /