New Data Presented at the Meeting Demonstrate Vitamin E May Help Prevent
Cardiovascular Events in Hp2-2 Diabetes
MONTVALE, N.J., Nov. 11 /PRNewswire-FirstCall/ -- Synvista Therapeutics, Inc. (Amex: SYI) today announced new data demonstrating that discontinuation of Vitamin E in patients with the Hp2-2 Diabetes may result in an increased risk of heart attack and rapid deterioration of HDL function. These results were presented today at the Annual Scientific Sessions of the American Heart Association, underway in New Orleans.
"These data demonstrate that after detecting Hp2-2 Diabetes, physicians modified treatment and achieved improved outcomes for specific patients by prescribing vitamin E. These benefits were lost when treatment with vitamin E was abandoned," said Noah Berkowitz, M.D., President and CEO of Synvista Therapeutics. "These types of studies provide confirmation that our clinical laboratory test which determines haptoglobin genotype may be useful in selecting and guiding patient therapy. We believe that the use of our test will be an important facilitator of personalized medicine and will provide a standard by which physicians can influence clinical outcome."
About the Study
In a prospective study called ICARE, 2,241 individuals with diabetes mellitus age 55 or over from 47 primary-care clinics in Israel underwent haptoglobin genotype testing and were randomized to receive either Vitamin E or placebo. The subjects were then followed for three years to track heart attack (myocardial infarction or MI), stroke and death (cardiovascular and all cause). During the study, it was determined that those who had the Hp2-2 genotype and who also received vitamin E had a significantly lower incidence of MI compared to placebo. Also, HDL function was significantly improved in Hp2-2 individuals who took vitamin E, compared to placebo. Following the study, it was discovered that in those Hp2-2 individuals who had received vitamin E, the incidence of MI after stopping vitamin E treatment significantly increased (0.4 percent on vitamin E vs. 1.8 percent off vitamin E, p=0.03). However, only two months after vitamin E withdrawal, HDL function had deteriorated to its level of dysfunction prior to the initiation of the study. Furthermore, in the 15-month period following the termination of the study, there was little demonstrable difference in the incidence of MI in those Hp2-2 individuals who had received vitamin E and stopped taking it after the end of the study compared to those who received placebo (1.8 percent vitamin E vs. 1.7 percent placebo, p=0.9).
About Hp2-2 Diabetes
The best understood function of haptoglobin, 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 that are well described in medical 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, randomized, 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).
About Synvista Therapeutics
Synvista Therapeutics is a biopharmaceutical company developing clinical laboratory tests and drugs to diagnose, treat and prevent cardiovascular disease in people with diabetes. The Company has developed a protein-based clinical test to identify patients with Hp2-2 diabetes. This test, or a similar genetic form of the test, may be useful in identifying 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.
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.
|SOURCE Synvista Therapeutics, Inc.|
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