Synvista Therapeutics Announces First Dosing of SYI-2074 in Clinical Trial for Psoriasis
15 Décembre 2008 - 2:30PM
PR Newswire (US)
MONTVALE, N.J., Dec. 15 /PRNewswire-FirstCall/ -- Synvista
Therapeutics, Inc. (NYSE Alternext US: SYI) has dosed the first
patient in a 30-patient Phase 2 clinical trial of its proprietary
topical GPx-mimetic, SYI-2074, in patients with psoriasis. The
trial is planned to be a 28-day multi-center, randomized,
double-blind, placebo controlled study to assess the efficacy of
topical SYI-2074, applied twice daily, for the treatment of
chronic, mild-to-moderate plaque psoriasis in adults. The trial is
being conducted in three centers in Israel. "We are very excited to
begin phase 2 clinical trials on SYI-2074 for psoriasis," said Noah
Berkowitz, M.D., Ph.D., President and Chief Executive Officer of
Synvista Therapeutics. "We believe that there is immense potential
to expand the scope of treatment modalities for psoriasis following
this trial and look forward to reporting results in the first
quarter of 2009." About SYI-2074 Synvista's GPx mimetic program is
based on the rational design of oral and topical drugs that mimic
the activity of glutathione peroxidase (GPx), the only enzyme in
the human body that reduces oxidized lipids. GPx is a well
validated target for drug development. Animal models have shown
that elevated activity of GPx protects animals from experiencing
heart attacks and atherosclerosis and reduced levels of GPx put
them at risk for those diseases or complications. In humans,
research suggests the risk of cardiovascular disease varies
inversely with levels of GPx activity (i.e., higher levels of
oxidized lipids promote the creation of oxygen free radicals and
reactive oxygen species (ROS), such as H2O2, which can promote
inflammation). As noted above, a topical form of our GPx mimetic
SYI-2074 is being developed for treatment of mild to moderate
plaque psoriasis, an inflammatory disease highly correlated with a
molecular signaling pathway that can be inhibited by SYI-2074.
About Psoriasis Psoriasis is an immune-mediated chronic
inflammatory disease usually characterized by red lesions or
silvery white scales on the skin, which usually occur on the scalp,
knees, elbows, the abdomen (around the navel) and the genitals. In
about a quarter of the cases, psoriasis can lead to psoriatic
arthritis, another inflammatory disease affecting the joints. While
the exact cause of the disease is unknown, it is believed that both
genetic and hormonal factors play a role. It is also known that the
TNF-alpha pathway plays a role in the progression of the disease.
Other companies have successfully developed drugs that also
interfere with TNF-alpha signaling, but these similar drugs are
given as injections and are indicated for more severe forms of the
disease. Synvista intends to differentiate SYI-2074 by developing a
topical formulation of the drug for the treatment of
mild-to-moderate psoriasis. 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
laboratory test that identifies diabetic patients with the
Haptoglobin genotype Hp2-2. 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 test 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 Company's ability to obtain
sufficient financial resources to continue operations, the risks
associated with the events described in this press release, future
clinical development of Synvista Therapeutics' 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 Kim Sutton Golodetz - Investors, , or Jules
Abraham - Media, , +1-212-838-3777, both of Lippert/Heilshorn &
Associates Web Site: htpp://www.synvista.com
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