Data Confirm Synvista Therapeutics Haptoglobin Diagnostic Test Kit Success in Rapidly Determining Cardiovascular Risk in Patient
11 Settembre 2008 - 2:00PM
PR Newswire (US)
MONTVALE, N.J., Sept. 11 /PRNewswire-FirstCall/ -- Synvista
Therapeutics, Inc. (AMEX:SYI) today announced findings from a study
that indicated Synvista's proprietary monoclonal enzyme immunoassay
can determine a person's haptoglobin pheno/genotype in less than
two hours, and can aid physicians in predicting cardiovascular risk
in patients with diabetes. The study was presented today at the
2008 Cardiovascular Biomarkers and Surrogate Endpoints Symposium in
Bethesda, Maryland. "This study shows the utility of our
proprietary technology to diagnose Hp2-2 Diabetes, a disease
affecting almost 7 million people in the United States," said Noah
Berkowitz, M.D., Ph.D., President and Chief Executive Officer of
Synvista Therapeutics. "We believe that the ease of use of our
haptoglobin diagnostic technology and rapid results bode well for
its acceptance as an important tool in the treatment of
cardiovascular disease in diabetic patients. In addition, we
believe that the development of genetic markers like those
identified by our test will continue to pave the way toward a
personalized medicine model that will benefit a wider variety of
patients in a more direct and reliably predictive manner." In the
study, investigators developed an ELISA (enzyme-linked
immunosorbent assay) using a monoclonal antibody that
differentiates between the three haptoglobin pheno/genotypes. Blood
samples from diabetic patients with known haptoglobin
pheno/genotypes were tested using Synvista's proprietary
methodology. Results demonstrated 99.5% accuracy in determining
each of the three haptoglobin types (48/48 Hp 1-1, 49/49 Hp2-1 and
90/91 Hp-2-2) with a greater than or equal to 98% sensitivity and
specificity for each phenotype. Additionally, a second paper was
presented at the Symposium highlighting the use of Synvista's
proprietary diagnostic kit for quantifying carboxymethyl-lysine
(CML), a dominant advanced glycation end product (A.G.E.). The
study demonstrated that CML is a biomarker of mortality in the
elderly. About Haptoglobin The best understood function of
haptoglobin (Hp), a common serum protein, is to bind free
hemoglobin released from red blood cells. Extracellular hemoglobin
(hemoglobin not found in red blood cells) is a potent oxidizing
agent capable of inflicting oxidative tissue damage. Haptoglobin
binds to this extracellular hemoglobin and inhibits hemoglobin
induced oxidation. Once hemoglobin is bound to haptoglobin, it is
rapidly cleared from the bloodstream by the liver or specialized
white blood cells. Haptoglobin in humans exists as three different
proteins that arise from one of three haptoglobin gene combinations
in the population, Hp 1-1 (16%), Hp2-2 (36%) and Hp1-2 (48%) For a
variety of reasons, well described in the literature, Hp2-2 is more
effective than Hp1-1 at preventing hemoglobin-induced oxidation in
the bloodstream and blood vessel wall. As a result, scientists have
determined that the rate of heart disease is five times higher in
Hp2-2 Diabetes than in Hp1-1 Diabetes. Hp2-2 Diabetes also has
higher rates of myocardial infarction and re-vascularization within
one year of angioplasty, and of heart failure and death following a
heart attack. Prospective clinical trials have demonstrated that
the rate of heart attack in Hp2-2 Diabetes can be decreased by the
administration of natural Vitamin E (400IU). This combination of
testing and treatment exemplifies pharmacogenomics, the targeting
of a particular drug on the basis of genetic testing. 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. 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 oral antioxidant drugs
to treat the HDL dysfunction seen in Hp2-2 Diabetes, a disease
affecting almost 7 million patients in the United States. The
Company is also developing alagebrium, a proposed breaker of
advanced glycation endproducts (AGEs) for the treatment of systolic
and diastolic heart failure. Diastolic heart failure 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 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' diagnostic tests and 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: Synvista Therapeutics, Inc.,
+1-201-934-5000, ; or Kim Sutton Golodetz (investors), , or Jules
Abraham (media), , both of Lippert/Heilshorn & Associates, for
Synvista Therapeutics, Inc., +1-212-838-3777 Web Site:
http://www.synvista.com/
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