Sexual HealthVIA Pharmaceuticals Announces Complete Enrollment In FDG-PET Phase 2 Study Of VIA-2291 In Cardiovascular Patients
VIA Pharmaceuticals, Inc. (Nasdaq: VIAP), a biotechnology company focused on the development of compounds for the treatment of cardiovascular and metabolic disease, announced that it has completed enrollment in a Phase 2 clinical trial of its lead drug, VIA-2291 in patients who have experienced an acute coronary syndrome event such as a heart attack or unstable angina. The randomized, double blind, placebo-controlled study examines the impact of VIA-2291 on plaque inflammation as measured by Positron Emission Tomography with fluorodeoxyglucose tracer (FDG-PET), as well as other standard biomarkers of inflammation, over 24 weeks following such an acute event. A total of 52 patients have been enrolled in the study, which is expected to report data in the second half of 2009.
VIA-2291 is designed to be a selective and reversible inhibitor of 5 Lipoxygenase, a key enzyme in the biosynthesis of leukotrienes, which are important mediators of inflammation believed to be involved in the development and progression of atherosclerosis. The FDG-PET study is the third Phase 2 clinical trial of VIA-2291 conducted by the Company in cardiovascular disease. In addition to being generally well-tolerated, earlier studies reported at the American Heart Association 2008 Scientific Sessions in November 2008, and the American Heart Association Arteriosclerosis, Thrombosis and Vascular Biology Annual Conference 2009 in May 2009, suggest multiple effects of the drug on inflammation, as measured through histology, biomarkers and advanced imaging. These include:
-- Significant, dose dependent, inhibition of Leukotriene B4 (LTB4) production
-- A significant reduction from baseline as compared with placebo of high sensitivity C-reactive protein (hs-CRP)
-- A reduction in necrotic core thickness relative to plaque thickness as measured with histology, and
-- A significant reduction in plaque volume and a reduced number of new plaque lesions as measured by serial multidetector computed tomography (MDCT) scans.
"There is growing weight to the evidence supporting VIA-2291"s effect on inflammation in atherosclerotic plaques," said Rebecca A. Taub, M.D., Sr. Vice President - Research & Development of VIA Pharmaceuticals. "No therapy currently exists to directly target inflammation, an underlying cause of atherosclerosis and major adverse cardiac events, such as heart attack and stroke. FDG-PET is a new and leading-edge imaging technology for cardiovascular patients, that we feel will provide yet another insight into VIA-2291"s ability to target plaque inflammation in patients with serious cardiovascular disease. In addition, the FDG-PET study focuses on the target patient population that is relevant to our anticipated, larger outcome studies."
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, 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.
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 borrow additional amounts under the 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 loan from Bay City Capital by the September 14, 2009 maturity date (or earlier if certain repayment acceleration provisions are triggered);
-- our ability to control our operating expenses;
-- our ability to comply with covenants included in the loan from Bay City Capital;
-- our ability to maintain the listing of our common stock on NASDAQ;
-- our failure to timely recruit and enroll patients for the FDG-PET clinical trial, as well as any future clinical trial;
-- 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 cardiovascular clinical trials using histological examinations, measurement of biomarkers, medical imaging and atherosclerotic plaque bioassays;
-- 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 or negated by authorities or by later stage clinical trials;
-- our ability to obtain necessary FDA approvals;
-- our ability to successfully commercialize VIA-2291;
-- 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, 2008 on file with the SEC.
All forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by the cautionary statements set forth above. Forward-looking statements speak only as of the date they are made, and VIA undertakes no obligation to update publicly any of these statements in light of new information or future events.
VIA Pharmaceuticals, Inc