Synvista Therapeutics Receives Approval to Begin Phase 2 Trial of Topical SYI-2074 in Psoriasis
MONTVALE, N.J., Sept. 29 /PRNewswire-FirstCall/ — Synvista Therapeutics, Inc. 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.”
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.
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