Synvista Therapeutics Announces Published Data Demonstrating Elevation of Carboxymethyl-Lysine (CML) Is Associated with Decline

Synvista Therapeutics Technology Provided CML Biomarker Data for Studies 


MONTVALE, N.J., Dec. 16  /PRNewswire-FirstCall/ -- Synvista Therapeutics, Inc. (NYSE Alternext US: SYI) today announced two publications demonstrating findings from studies that indicated that the presence of the advanced glycation end product (A.G.E.) called carboxymethyl-lysine (CML) in older adults is associated with a decline in renal function and arterial stiffness in older adults. Kits developed through a license to Synvista's technology were used in these studies. Synvista is validating this clinical diagnostic assay as it prepares to submit a CML kit for 510(k) clearance in the second half of 2009.

"These studies represent an important next step in our understanding of the role of CML in an elderly population, and they provide physicians more information that may be useful in the prevention of cardiovascular and renal disease, particularly in older adults," said Richard D. Semba, M.D., M.P.H, W. Richard Green Professor of Ophthalmology, The Johns Hopkins University School of Medicine and lead author of both studies. "As we have learned, the elevation of CML is preventable in many cases, as it can be mitigated by changes in diet. Therefore, to bring a clearer understanding of this A.G.E. to the forefront may help doctors better explain to their patients how to help prevent cardiovascular and renal complications."

In one study, published in a recent edition of American Journal of Hypertension, investigators measured 493 adult subjects participating in the Baltimore Longitudinal Study of Aging for their aortic pulse wave velocity (an index of aortic stiffness) and CML (using Synvista's proprietary technology). Results demonstrated that elevated levels of CML in these subjects corresponded to increased arterial stiffness, a known predictor of cardiovascular disease.

The second study, published in a recent edition of the European Journal of Nutrition, demonstrated that the presence of CML in older adults is independently associated with chronic kidney disease, and may be an independent predictor of decline in renal function. This population-based study of aging in a population from Tuscany, Italy, followed 1,008 adults age 65 and over. At the conclusion of the study after six months, there was a clear correlation between those subjects with elevated CML levels and those that had renal impairment, adjusting for those that already had chronic kidney disease at the outset of the study.

"These studies also clearly demonstrate the utility of our technology to diagnose CML in older adults. Like Dr. Semba, we firmly believe that an increased understanding of CML in older adults will help doctors understand the relationship between the presence of A.G.E.s and future cardiovascular and renal disease, and help patients to understand how to lower their CML levels to reduce cardiovascular and other types of risk," said Noah Berkowitz, M.D., Ph.D., President and Chief Executive Officer of Synvista Therapeutics. "We believe that a clinical diagnostic test, upon clearance by the FDA, to measure CML levels may one day provide these patients and their physicians with a pathway for clinical intervention. We hope as a next step to look at the relationship between cardiovascular outcome and mortality."

About CML

The process of aging naturally increases the presence of damaged proteins. Often this damage is caused by the attachment of glucose to proteins in a process called glycation. When the glucose-modified proteins go through further oxidation, the resulting modified protein is described as an Advanced Glycation End Product (A.G.E.). These damaged proteins are often dysfunctional, inflammatory and damaging to organs such as the heart, kidney and skin among others. Collagen (a protein normally found in connective and structural tissue) is an example of a protein that can be converted into an A.G.E. As a consequence of advanced glycation and oxidation, collagen fibers can cross link, which makes them less flexible. When formed in the heart and blood vessels (the cardiovascular system), cross linked collagen induces stiffness, a loss of adaptability and decreased reactivity which makes the heart and blood vessels act less effectively and may increase the risk of cardiovascular complications.

Carboxymethyl-lysine, or CML, is one highly common A.G.E. believed to play a role in cardiovascular mortality, renal insufficiency, increased aortic stiffness, and other clinical phenomena associated with aging. Synvista Therapeutics is conducting clinical trials to better understand the role of CML in age-related system decline.

Preliminary studies are revealing that CML is relevant to the cause of loss in functionality of certain bodily systems (mainly the cardiovascular and renal systems). It seems clear that the presence and level of circulating CML may be considered a biomarker for the likelihood of system decline. This is because CML in the blood is similar to serum cholesterol biomarkers in that they can be lowered by modifying diet or through drug intervention (e.g., use of statins). Synvista's current research is designed to clarify the relationship between A.G.E.s and chronic cardiovascular and renal disease.

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 end products (A.G.E.s) 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, the Company's ability to obtain sufficient financial resources to continue operations, 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. 

DATASOURCE: Synvista Therapeutics, Inc.



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