Synvista Therapeutics Announces Availability of Haptoglobin Genotyping Technology at The Annual Scientific Sessions of the Ameri
10 Novembro 2008 - 11:30AM
PR Newswire (US)
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." About Haptoglobin 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. DATASOURCE: Synvista
Therapeutics, Inc. CONTACT: Synvista Therapeutics, Inc.,
+1-201-934-5000, ; or Lippert/Heilshorn & Associates,
+1-212-838-3777, or Investors, Kim Sutton Golodetz, , or Media,
Jules Abraham, Web Site: http://www.synvista.com/
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