MONTVALE, N.J., Sept. 17 /PRNewswire-FirstCall/ -- Synvista Therapeutics, Inc. (Amex: SYI) today announced that a Letter to Stockholders is now posted to the Company's Web site http://www.synvista.com. The text is as follows:
To Our Stockholders:
The team at Synvista Therapeutics has made tremendous progress in our
efforts to deliver on the promise of personalized medicine, and to redefine
the treatment of cardiovascular disease in diabetics as well as the
treatment of other diseases in the general population. Since my last letter
in August 2007, our clinical trials with SYI-2074 for the treatment of
heart disease in diabetics had inconclusive results, and we opted not to
move forward with the compound's development in this indication. However,
we have a robust pipeline on which we are building our business. We have:
-- Advanced our Haptoglobin (Hp) diagnostic test.
-- Developed a test for Carboxy-methyl-lysine (CML), a biomarker of
advanced glycation end product (A.G.E.) formation, which is believed to
play a part in cardiovascular disease.
-- Initiated two Phase 2 trials with alagebrium for chronic heart failure.
-- Advanced the development of a topical formulation for the use of
SYI-2074 in the treatment of psoriasis.
-- Chosen a lead Glutathione peroxidase mimetic generated in a discovery
collaboration with Provid Pharmaceuticals, that is now being evaluated
for its ability to restore reverse cholesterol transport and treat
-- Strengthened our management team and board of directors with
appointments in research, development and marketing.
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 target of 260 patients. As a result of accumulating data on the connection between CML levels and cardiovascular outcomes and the progress of our alagebrium development program, we have begun to commercialize our CML assay. To date, a licensee has sold more than 6,000 research- use-only tests. We are preparing the kit for 510(k) submission in the first half of 2009.
We have initiated two Phase 2 studies with alagebrium. Alagebrium is a proposed breaker of A.G.E.s for the treatment of heart failure.
The BENEFICIAL study, which began in November 2007, is a 100-patient study in chronic heart failure (CHF) being conducted at a single site in The Netherlands. This study is designed to involve nine months of treatment and is designed to measure the effect of alagebrium on exercise tolerance in patients with CHF. The study objective is to improve maximal oxygen consumption (VO2max), which is highly correlated with an improvement in myocardial function in patients with CHF. It also examines the ability of alagebrium to breakdown A.G.E.s by tracking levels of CML. As of the time of this writing, the study is more than 50% enrolled and is on track for completion in late 2009.
The BREAK study, which enrolled the first of 160 patients in May 2008, is a randomized, double-blind, placebo-controlled study at approximately 25 U.S. sites intended to assess the effect of six months of oral treatment with 400mg (200mg twice daily) of alagebrium versus placebo in patients with diastolic heart failure. Diastolic heart failure is particularly common among people with diabetes, and our intent is that at least one-half of the subjects enrolled in this study will have diabetes. The primary efficacy measure of the BREAK study is improvement of exercise tolerance as assessed by the six-minute walk test, an accepted regulatory endpoint. In addition, there will be a number of secondary and tertiary measurements including the effect on CML. This study also is on track for completion in late 2009.
We have met with the FDA on these two studies and believe that our clinical endpoints are acceptable to them.
While we decided not to pursue the development of SYI-2074 in heart disease, we believe that the compound has characteristics that may make it a compelling treatment for psoriasis. We completed the formulation development for topical SYI-2074 in the third quarter of 2008, and we expect to begin patient enrollment in a 30-patient Phase 2 study in this area in October 2008.
We also have developed a new family of glutathione peroxidase mimetics with properties that may be more attractive than SYI-2074 in treating heart disease. We have selected the lead compound and have begun preclinical testing. We have shown that our new family of compounds can attenuate the loss of cholesterol efflux seen in select patients with diabetes. Higher levels of cholesterol efflux may correlate with reduced atherosclerosis.
We welcomed several important additions to the Synvista management team in the past year. Carl Mendel, M.D., was appointed to the position of Vice President, Clinical Development and Chief Medical Officer and is responsible for the clinical-stage development of the Company's lead products. Dr. Mendel brings 15 years of experience in the pharmaceutical industry, successfully directing development programs in metabolism, obesity, cardiovascular disease, abuse potential, oncology, virology and other therapeutic areas. David C. Tantillo joined us as Senior Director, Marketing and Sales, a newly created position and brings to Synvista nearly 20 years of broad-based industry experience. Mr. Tantillo is responsible for planning and implementing commercialization of the Company's haptoglobin diagnostic test.
We strengthened our board of directors with the appointment of John F. Bedard, expanding our board to four members. Mr. Bedard brings 25 years of highly relevant experience, having successfully directed development and registration programs in various therapeutic areas, including cardiovascular and metabolic diseases, dermatology, gastroenterology and immunology.
We are very excited about the role Synvista has to play in fulfilling important, unmet medical needs in diabetic and other patients as we advance our pipeline through development and into commercialization.
Thank you for your continued interest in Synvista. I look forward to keeping you apprised of our progress.
Noah Berkowitz, M.D., Ph.D.
President and Chief Executive Officer
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.
|SOURCE Synvista Therapeutics, Inc.|
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