VIA Pharmaceuticals and MHI Announce Publication of VIA-2291 5-Lipoxygenase Inhibitor Clinical Study Data in Circulation: Cardiovascular Imaging
Data From ACS Study Demonstrate a Significant Reduction in Leukotrienes and New Coronary Plaques in High-Risk Patients
SAN FRANCISCO, CA and MONTREAL--(Marketwire - May 20, 2010) - VIA Pharmaceuticals, Inc. (PINKSHEETS: VIAP), a biotechnology company focused on the development of compounds for the treatment of cardiovascular and metabolic diseases, and The Montreal Heart Institute today announced the publication of clinical trial data from a study of VIA-2291, a 5-Lipoxygenase inhibitor (5-LO), in volume 3, issue 3 of the American Heart Association journal Circulation: Cardiovascular Imaging, published May 19, 2010.
"Despite standard-of-care treatment, patients with recent acute coronary syndromes remain at high risk of recurrent vascular events, and this risk is greater in patients with evidence of ongoing inflammation," said Dr. Jean-Claude Tardif, Director of the Montreal Heart Institute Research Centre, professor of medicine at the University of Montreal, principal investigator of the VIA-2291 ACS trial and the lead author of the publication. "VIA-2291 is designed to target the underlying inflammatory disease process active in atherosclerosis, including the reduction of leukotrienes, an approach not addressed by currently available treatment. These newly published data strongly support the evaluation of VIA-2291 in larger outcome trials."
The publication includes data from VIA's ACS study, a randomized, double-blind, placebo controlled Phase 2 study of VIA-2291 in 191 patients who recently experienced acute coronary syndromes (ACS), including heart attack or unstable angina. Patients on standard care medications (statins, blood pressure medications, and platelet inhibitors) were treated once daily for 12 weeks with one of three doses of VIA-2291 or placebo. The study met its primary endpoint by demonstrating a statistically significant, dose-dependent inhibition of whole blood stimulated leukotriene LTB4 production at 12 weeks (P < 0.0001) demonstrating greater than 80% inhibition in 90% of patients. Leukotrienes are important mediators of inflammation believed to be involved in the development and progression of atherosclerotic plaque. VIA-2291 is designed to be a selective, potent and reversible inhibitor of 5-LO, a key enzyme in the biosynthesis of leukotrienes. A significant reduction of urine leukotriene LTE4, a marker of systemic leukotriene production, was also obtained in all dose groups, a secondary endpoint of the study. The drug was found to be well tolerated, with no serious adverse events considered related to study drug.
A subset of 93 patients were also evaluated in a 64-slice coronary CT examination at baseline and at 24 weeks to study VIA-2291's effect over a longer timeframe. Among evaluable patients, new coronary plaques were observed in 5 of 18 (27.8%) placebo and 2 of 42 (4.8%) VIA-2291-treated patients (P=0.01). A reduction in non-calcified plaque volume at 24 weeks versus placebo was observed in VIA-2291-treated groups in the patients in whom this endpoint was analyzable (P < 0.01).
Although unchanged at 12 weeks in the main study, concentrations of high-sensitivity C-reactive protein (hs-CRP), a validated marker of inflammation and risk for cardiovascular diseases, were reduced by 67% in the VIA-2291 100-mg treatment group relative to placebo at 24 weeks (P=0.0002) among patients in the extension sub-study.
The publication can be found on the American Heart Association's website at http://circimaging.ahajournals.org.
About VIA Pharmaceuticals, Inc.
VIA Pharmaceuticals, Inc. is a biotechnology company focused on the
development of compounds for the treatment of cardiovascular and
metabolic disease. VIA's lead candidate, VIA-2291, targets a
significant unmet medical need: reducing inflammation in plaque,
which is an underlying cause of atherosclerosis and its
complications, including heart attack and stroke. In addition,
VIA's pipeline of drug candidates includes other compounds to
address other underlying causes of cardiovascular disease: high
cholesterol, diabetes and inflammation. For more information,
visit: http://www.viapharmaceuticals.com.
About the Montreal Heart Institute
Founded in 1954 by Dr. Paul David, the Montreal Heart Institute
constantly aims for the highest standards of excellence in the
cardiovascular field through its leadership in prevention,
ultra-specialized care, professionals training, clinical and
fundamental research, and assessment of new technologies. The
Institute is part of a vast network of excellence in health formed
by the Université de Montréal and its affiliated
institutions. To learn more about the Institute, please visit our
website at www.icm-mhi.org.
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our potential for future growth and the development of our product
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Contact Information:
VIA Pharmaceuticals, Inc.
Lawrence K. Cohen
Chief Executive Officer
415.283.2209
Media contact:
Andrea Rabney
Argot Partners
212.600.1902
Montreal Heart Institute
Sylvain Bouffard
Director, Communications and partnerships
514-376-3330, extension 3074
Email Contact
Posted: May 2010
