Synvista Therapeutics Announces Data Further Demonstrating the Value of Haptoglobin Genotyping in Diabetic Patients During AHA M
November 11 2008 - 8:30AM
PR Newswire (US)
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. DATASOURCE: Synvista
Therapeutics, Inc. CONTACT: Synvista Therapeutics, Inc.,
+1-201-934-5000, ; or Investors, Kim Sutton Golodetz, , or Media,
Jules Abraham, , both of Lippert/Heilshorn & Associates,
+1-212-838-3777 Web Site: http://www.synvista.com/
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