We believe that we have a clear development pathway for our immunoassay test to determine the 2-2 genotype of Hp and have validated the accuracy of a commercial kit, as presented at the 2008 Cardiovascular Biomarkers and Surrogate Endpoints Symposium in Bethesda, Maryland, on September 11, 2008. Our pre-IDE meeting with the U.S. Food and Drug Administration has been completed, and we are on track to submit a 510(k) application for marketing clearance of this kit in the fourth quarter of 2008. In preparation for marketing clearance, we are preparing to launch the test with a small, dedicated sales force in the U.S., initially focused on high prescribers in the Mid-Atlantic region. We are also preparing a CE mark submission to market the test through distributors in the EU.
Of particular significance, research first presented at the American Heart Association's (AHA) Scientific Sessions November, 2007 in Orlando, Florida, and subsequently published in Arteriosclerosis, Thrombosis and Vascular Biology 2008 Feb;28(2):341-7. Epub 2007 Nov. 21, demonstrated that in patients with Diabetes Mellitus (DM) who had the Haptoglobin 2-2 (Hp2-2) genotype, supplementation with Vitamin E therapy decreased cardiovascular events. We believe that this provides a compelling disease management opportunity for payers who can recommend the use of our test to determine the appropriate use of Vitamin E and the potential reduction of heart attacks resulting in considerable healthcare savings.
In addition to these commercial and scientific advances for the Hp
test, we have made considerable progress in the development of a test for
CML, another proprietary cardiovascular risk marker. Last year, researchers
published reports that CML may predict outcomes in patients with heart
failure. Our product candidate alagebrium has been shown to affect CML
levels in animal models and the marker is being tracked in our alagebrium
Phase 2 programs involving a targe
|SOURCE Synvista Therapeutics, Inc.|
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