New Data Presented at the Meeting Report the Use of Haptoglobin Typing to Predict Cardiovascular Risk, and Benefit From Tight Glycemic Control in Diabetics
MONTVALE, N.J., Nov. 10 /PRNewswire-FirstCall/ -- Synvista Therapeutics, Inc. (Amex: SYI) today announced at the Annual Scientific Sessions of the American Heart Association, underway in New Orleans, that a new clinical test to determine haptoglobin (Hp) genotype utilizing intellectual property licensed from Synvista is now available. Knowledge of Hp genotype may help physicians to assess cardiovascular risk and guide treatment choices in their patients with diabetes. Several presentations relating to the Company's technology are being delivered during the Scientific Sessions, including one showing that older individuals with diabetes mellitus and the Hp2-2 genotype (Hp2-2 Diabetes) demonstrate a significantly higher mortality rate from cardiovascular disease than those who do not have the Hp 2-2 genotype; and another demonstrating that tight glycemic control reduces the incidence of heart attack (myocardial infarction - MI) only in Hp2-2 Diabetes.
The test, which was developed and validated by ARUP Laboratories, will be performed under a license agreement with Synvista in ARUP's CLIA-certified laboratory. In addition, Synvista has developed its own test utilizing different technology than ARUP which it intends to market as a diagnostic kit after submitting a 510(k) to, and obtaining clearance from, the U.S. Food and Drug Administration (FDA).
"We are extremely pleased that our intellectual property will have a role in making personalized medicine a reality," said Noah Berkowitz, M.D., President and CEO of Synvista Therapeutics. "We believe that the ease of use of our kit designed to detect Hp2-2 Diabetes, once it is cleared by the FDA, and its anticipated widespread availability bode well for its acceptance as an important tool in the detection of cardiovascular risk in diabetic patients. In turn, our test can help physicians make better treatment decisions for patients with Hp2-2 Diabetes."
At present, the haptoglobin genotype test is offered by ARUP Laboratories. A network of participating reference laboratories may forward samples to ARUP. Physicians interested in haptoglobin testing can call ARUP's 24 hour a day customer service line (800-522-2787) to obtain information on how to submit a blood sample for testing (Refer to ARUP test number 0040116).
About the Studies
In the 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 followed for three years to track heart attack (myocardial infarction), stroke and death (cardiovascular and all cause). The study included 708 individuals with the Hp 2-2 genotype and 1,533 with one of the other two Hp genotypes (1-1 and 2-1). While baseline measurements showed no difference between the two groups in diabetes characteristics (HbA1c, duration), over the next three years, cardiovascular death was five-fold higher in the Hp 2-2 group (p=0.0001) and non-fatal MI increased by more than 50 percent (p=0.068). The differences in mortality were not affected by adjustment for diabetes characteristics or conventional cardiovascular risk factors.
The second study, another sub-study from ICARE, followed the results of tight glycemic control for a subgroup of patients during the three-year follow-up. After stratification of participants to those with an average HbA1c of above or below 7.0, results demonstrated that only those individuals who had the Hp2-2 genotype and who maintained strict glycemic control showed a reduction in the incidence of MI. Study investigators concluded that the Hp2-2 genotype may have played a key role in the success of glycemic control to prevent MI, compared to other Hp genotypes.
"These results confirm the previously reported impact of the Hp 2-2 genotype in individuals with diabetes," said Dr. Berkowitz. "We believe that this type of genotype testing will ultimately evolve into a key factor in improving and prolonging the lives of diabetic patients."
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, some medical researchers 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.
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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