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.
Forward Looking Statements
This press release may contain "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or to VIA's future financial performance and involve known and unknown risks, uncertainties and other factors that may cause VIA's actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. In some cases, you can identify forward-looking statements by the use of words such as "may," "could," "expect," "intend," "plan," "seek," "anticipate," "believe," "estimate," "predict," "potential," "continue" or the negative of these terms or other comparable terminology. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond VIA's control and which could materially affect actual results, levels of activity, performance or achievements.
Factors that may cause actual results to differ materially from current expectations include, but are not limited to:
- our ability to find a market maker to apply and be cleared by the Financial Industry Regulatory Authority to quote our common stock on the OTC Bulletin Board;
- ability and willingness of active market makers in our common stock to trade our common stock on the Pink Sheets under a "piggyback qualification";
- our ability to borrow additional amounts under the new loan from Bay City Capital, which is subject to the discretion of Bay City Capital;
- our ability to obtain necessary financing in the near term, including amounts necessary to repay the previous loan from Bay City Capital following the April 1, 2010 maturity date;
- our ability to control our operating expenses;
- our ability to comply with covenants included in the loans from Bay City Capital;
- our ability to operate following the implementation of our strategic restructuring;
- our ability to comply with SEC reporting obligations following our strategic restructuring;
- our ability to timely recruit and enroll patients in any future clinical trials;
- our failure to obtain sufficient data from enrolled patients that can be used to evaluate VIA-2291, thereby impairing the validity or statistical significance of our clinical trials;
- our ability to successfully complete our clinical trials of VIA-2291 on expected timetables and the outcomes of such clinical trials;
- complexities in designing and implementing cardiometabolic clinical trials using surrogate endpoints in Phase 1 and Phase 2 clinical trials which may differ from the ultimate endpoints required for registration of a candidate drug;
- the results of our clinical trials, including without limitation, with respect to the safety and efficacy of VIA-2291;
- if the results of the ACS and CEA studies, upon further review and analysis, are revised, interpreted differently by regulatory authorities or negated by later stage clinical trials;
- our ability to obtain necessary FDA approvals, including to initiate future clinical trials of VIA-2291;
- our ability to successfully commercialize VIA-2291;
- our ability to identify potential clinical candidates from the family of DGAT1 compounds licensed and move them into preclinical development;
- our ability to obtain and protect our intellectual property related to our product candidates;
- our potential for future growth and the development of our product pipeline, including the THR beta agonist candidate and the other compounds licensed from Roche;
- our ability to obtain strategic opportunities to partner and collaborate with large biotechnology or pharmaceutical companies to further develop VIA-2291;
- our ability to form and maintain collaborative relationships to develop and commercialize our product candidates;
- general economic and business conditions; and the other risks described under Item IA "Risk Factors" in our Annual Report on Form 10-K for the fiscal year ended December 31, 2009 on file with the SEC.
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