MONTVALE, N.J., Sept. 11 /PRNewswire-FirstCall/ -- Synvista Therapeutics, Inc. 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 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.
CONTACT: Synvista Therapeutics, Inc., +1-201-934-5000, ir@synvista.com; or
Kim Sutton Golodetz (investors), kgolodetz@lhai.com, or Jules Abraham
(media), jabraham@lhai.com, both of Lippert/Heilshorn & Associates, for
Synvista Therapeutics, Inc., +1-212-838-3777
Web site: http://www.synvista.com/
