Synvista Therapeutics,
Inc. (Amex: SYI) announced data from three Phase 2 trials (Trials
201a, 201 and 203) of SYI-2074 in Type 2 diabetic patients. Trial 201a
established that haptoglobin (Hp) types, the target of Synvista’s
proprietary haptoglobin modification test currently under enlargement,
correlated with a difference in baseline levels of plasma isoprostanes,
confirming that Hp2-2 in diabetic patients is associated with increased
oxidized lipids. The mean F2a isoprostane level in Hp2-2 diabetic patients
was 632 ng/mg Cr and in Hp1-1 diabetic patients was 453 ng/mg Cr (p=0.001).
Trial 201 showed that SYI-2074, in Hp2-2 diabetic patients, did not
protest a dose-related improvement in all oxidized lipids and all
markers of oxidative accentuation after one month. In Hard luck 203, SYI-2074 did not
minister to substantiation of protection against cardiac mistreatment in diabetic patients
who were undergoing angioplasty. The Company has consequence decided not to
move forward the development of SYI-2074 as a treatment for acute coronary
syndrome, while it continues to inspect and analyze the results of these
studies.
These State 2 results do not impact the Company’s plans to examination a
topical formulation of SYI-2074 in prize psoriasis. Synvista expects to
begin enrollment of patients with mild-to-soothe plaque psoriasis in a
Phase 2 trial in the third quarter of 2008, as originally planned. The
Company is continuing to appraise a series of deny-up compounds to SYI-2074
in preclinical studies, on the basis of some of the signals in these
trials. The Company hopes to provide an update on this program during the
third quarter of 2008.
“We are choosing not to advance the SYI-2074 program in the very much
competitive area of canny coronary syndrome at this time, in the insufficiency of
stronger surrogate markers of efficacy,” said Noah Berkowitz, M.D., Ph.D.,
President and Chief Executive Officer of Synvista Therapeutics.
“We are pleased to have established correlation between increased
plasma isoprostanes and haptoglobin type, as we have the courage of one’s convictions pretend this further
validates the biology underlying our proprietary haptoglobin study.
Haptoglobin typing has been used in studies that have evaluated more than
20,000 patients, and researchers father demonstrated that Hp2-2 patients with
diabetes are at high risk for myocardial infarction, heart non-starter and
stroke. To that extreme, our diagnostic test is on way to be available
commercially in the imperfect quarter of 2009. Another, we are planning to
submit a kit measuring CML (carboxy-methyl-lysine), another increasingly
well-validated, cardiovascular biomarker, for the duration of FDA marketing clearance in
2009,” Dr. Berkowitz continued. “We are also moving forward with our
alagebrium program, which began enrollment last month in a Include 2 study
for diastolic sentiments failure in Haptoglobin 2-2 diabetic patients, which
complements a understudy Phase 2 study in systolic heart failure, begun model
November and almost half enrolled.”
About the Studies
Hardship 201 was a Step 2, placebo-controlled, dose-escalation study in
which patients with diabetes and Hp2-2 were given SYI-2074 at 20, 40 or
80mg or placebo three times habitually for 28 days. The study evaluated the
impact of these doses on inflammatory biomarkers, and the quality and
sum of their cholesterol. Results found that SYI-2074 demonstrated
gain in some but not all of these biomarkers.
Headache 201a was a Juncture 2, placebo-controlled sub-study of Dry run 201.
Patients with diabetes, meeting enrollment criteria over the extent of Check 201 were
tested respecting haptoglobin type. Patients with Hp2-2 or Hp1-1 were evaluated
fit baseline levels of plasma and urinary isoprostanes, CRP,
myeloperoxidase, paraoxonase and other markers of infection or oxidative
stress.
Litigation 203 was a Phase 2, placebo-controlled study evaluating 40mg of
SYI-2074 administered three times continuously for two days in diabetic patients
undergoing angioplasty. The main endpoint of the study was reduction of
the amount of heart muscle enzyme (CK-MB) released from the heart as a
consequence of the procedure. Results showed that there was no significant
reduction in CK-MB, which indicates that the normal harm to verve muscle
following an angioplasty occurred during the procedure regardless of the
administration of SYI-2074.
About Synvista Therapeutics
Synvista Therapeutics is a biopharmaceutical company developing drugs
to treat and prevent cardiovascular disease and nephropathy in people with
diabetes. The Company believes it has identified several product candidates
that represent novel approaches to some of the largest pharmaceutical
markets. The Company’s portfolio includes orally bioavailable,
organoselenium mimics of glutathione peroxidase. These compounds metabolize
lipid peroxides and drink the capacity to limit sore related to
oxidative worry. It currently plans a program in psoriasis with its get under way
compound. The Company is developing a clinical diagnostic investigation, based on
cardiovascular risk assessment, using Haptoglobin characterization, to
identify patients at steep gamble concerning cardiovascular complications of
diabetes. It is also developing a kit to measure CML, another potency
cardiovascular peril marker.
Synvista Therapeutics also is developing alagebrium, a proposed breaker
of AGEs as regards the treatment of diastolic heart failure. This complaint
represents a rapidly growing trade in of unmet medical need, singularly
common among diabetic patients. Alagebrium has demonstrated relevant
clinical activity in two Phase 2 clinical trials in heart remissness, as well
as in animal models of pith dud 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 have to do with 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, expected clinical
maturing of Synvista Therapeutics’ product candidates, and other risks
identified in Synvista Therapeutics’ filings with the Securities and
Argument Commission. Assist information on risks faced by Synvista are
inclusive below the caption “Risk Factors” in Synvista Therapeutics’ Annual
Report on Appearance 10-K for the year ended December 31, 2007. These filings are
nearby on a website maintained by the Securities and Exchange Commission
at http://www.sec.gov. The information contained in this huddle release is
accurate as of the date indicated. Actual results, events or performance
may be contradictory materially. Synvista Therapeutics undertakes no obligation to
publicly release the result of any revamping to these forward-looking
statements that may be made to echo events or circumstances after the
period hereof or to reflect the occurrence of unanticipated events.
Synvista Therapeutics, Inc.
http://www.synvista.com