Synvista
Therapeutics, Inc. (Amex: SYI) announces that it has received approval from
the Israeli Ministry of Health to begin a Phase 2 trial of a topical
formulation of SYI-2074 in mild-to-moderate plaque psoriasis. The trial is
expected to begin enrollment in the fourth quarter of 2008 at three sites
in Israel, and is designed to enroll a total of 30 patients in a
randomized, placebo-controlled study. Top-line results are expected in the
first quarter of 2009.
Previously, it has been reported that SYI-2074 blocks TNF-alpha
activated expression of cell adhesion molecules, I-CAM and V-CAM, which may
be essential for cellular migration. The TNF-alpha signaling pathway is an
established target for drug development in psoriasis and other autoimmune
diseases. As a topical, SYI-2074 is not expected to have the side effects
associated with systemic treatment using anti-TNF agents.
Noah Berkowitz, M.D., President and Chief Executive Officer of Synvista
said, "There have been 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 psoriasis. We believe that a
topical drug will provide patients with an important alternative in the
treatment of this disease."
About Psoriasis
According to the National Institutes of Health as many as 7.5 million
Americans have psoriasis, a non-contagious, lifelong skin disease. The most
common form, plaque psoriasis, appears as raised, red patches or lesions
covered with a silvery white buildup of dead skin cells, called scale.
Psoriasis varies from person to person, both in severity and how it
responds to treatment. Psoriasis is now recognized to be a disease that can
be modified by drugs that inhibit TNF-alpha signaling. Current treatment
for severe psoriasis includes biologic drugs that are costly, potentially
toxic, and require intravenous administration. In addition, steroids often
work for patients with mild-to-moderate psoriasis, yet they carry side
effects and are generally not recommended for long-term use.
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. Diastolic heart
failure represents a rapidly growing market of unmet medical need,
particularly common among diabetic patients. Alagebrium has demonstrated
relevant clinical activity in two Phase 2 clinical trials in heart failure,
as well as in animal models of heart failure and nephropathy, among others.
Alagebrium has been tested in approximately 1,000 patients in multiple
Phase 1 and Phase 2 clinical trials, allowing Synvista Therapeutics to
assemble a sizeable human safety database.
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.
Synvista Therapeutics, Inc.
http://www.synvista.com
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