VIA Pharmaceuticals Announces Faultless Enrolment In FDG-PET Chapter 2 Study Of VIA-2291 In Cardiovascular Patients
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VIA Pharmaceuticals, Inc. (Nasdaq: VIAP), a biotechnology gathering focused on the buildup of compounds for the treatment of cardiovascular and metabolic disease, announced that it has completed enrollment in a Page 2 clinical probation of its example drug, VIA-2291 in patients who have experienced an acute coronary syndrome event such as a heart attack or unstable angina. The randomized, banal blind, placebo-controlled discover examines the force of VIA-2291 on plaque inflammation as measured by Positron Emission Tomography with fluorodeoxyglucose tracer (FDG-PET), as hearty as other standard biomarkers of inflammation, over 24 weeks following such an acute event. A complete of 52 patients get been enrolled in the study, which is expected to report info in the moment 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 influential mediators of inflammation believed to be involved in the enlargement and progression of atherosclerosis. The FDG-PET read is the third Period 2 clinical proof of VIA-2291 conducted by the Society in cardiovascular disease. In appendix to lifetime generally well-tolerated, earlier studies reported at the American Heart Association 2008 Scientific Sessions in Nov 2008, and the American Heart Convention Arteriosclerosis, Thrombosis and Vascular Biol Annual Convention 2009 in May 2009, propose multiple effects of the drug on inflammation, as measured ended histology, biomarkers and modern imaging. These include:
-- Significant, potion dependent, inhibition of Leukotriene B4 (LTB4) production
-- A indicative reduction from baseline as compared with placebo of grand sensitivity C-reactive protein (hs-CRP)
-- A reduction in necrotic core thickness relative to plaque thickness as measured with histology, and
-- A facund reduction in plaque volume and a reduced number of distinct plaque lesions as measured by serial multidetector computed tomography (MDCT) scans.
"There is growing weight to the evidence supporting VIA-2291's development on inflammation in atherosclerotic plaques," said Rebecca A. Taub, M.D., Sr. Vice Head of the state - Evaluation & Manner of VIA Pharmaceuticals. "No therapy currently exists to directly goal inflammation, an underlying cause of atherosclerosis and major adverse cardiac events, such as feelings attack and stroke. FDG-PET is a au courant and leading-edge imaging technology for cardiovascular patients, that we feel will favor yet another drift into VIA-2291's potency to target plaque inflammation in patients with bent on cardiovascular disease. In addition, the FDG-PET interpret focuses on the body patient population that is valuable to our anticipated, larger outcome studies."
About VIA Pharmaceuticals, Inc.
VIA Pharmaceuticals, Inc. is a biotechnology collection focused on the development of compounds for the treatment of cardiovascular and metabolic disease. VIA's front candidate, VIA-2291, targets a convincing unmet medical need: reducing inflammation in plaque, an underlying cause of atherosclerosis and its complications, including heart barrage and stroke. In addition, VIA's pipeline of drug candidates includes other compounds to domicile other underlying causes of cardiovascular disease: high cholesterol, diabetes and inflammation.
Forward Looking Statements
This press proceeds may include "forward-looking" statements within the thought of the Private Securities Litigation Change Act of 1995. These statements relate to future events or to VIA's future financial performance and comprehend known and alien risks, uncertainties and other factors that may element VIA's actual results, levels of activity, performance or achievements to be materially discrepant from any impending 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 avail of contents such as "may," "could," "expect," "intend," "plan," "seek," "anticipate," "believe," "estimate," "predict," "potential," "continue" or the denying of these terms or other comparable terminology. You should not place undue reliance on forward-looking statements owing to they subsume accepted and anonymous risks, uncertainties and other factors which are, in some cases, beyond VIA's determination and which could materially prevail actual results, levels of activity, performance or achievements.
Factors that may justification actual results to differ materially from happening expectations include, but are not limited to:
-- our ability to borrow more amounts under the loan from Bay Megalopolis Capital, which is contents to the discretion of Bay Municipality Capital;
-- our aptitude to obtain all-important financing in the near term, including amounts necessary to go back the loan from Bay Metropolis Money by the Sep 14, 2009 maturity date (or earlier if certain repayment acceleration provisions are triggered);
-- our knack to control our operating expenses;
-- our bent to comply with covenants included in the loan from Bay City Capital;
-- our force to cache the listing of our common inventory on NASDAQ;
-- our failure to well timed obtain and enrol patients for the FDG-PET clinical trial, as well as any imminent clinical trial;
-- our failure to chalk up sufficient information from enrolled patients that can be used to evaluate VIA-2291, thereby impairing the validity or statistical significance of our clinical trials;
-- our faculty to successfully integral 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;
-- whether the results of the ACS and CEA studies, upon further review and analysis, are revised or negated by authorities or by consequent leaf clinical trials;
-- our power to annex crucial FDA approvals;
-- our capacity to successfully commercialize VIA-2291;
-- our ability to drum up 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 capacity to capture strategic opportunities to partner and cooperate with large biotechnology or pharmaceutical companies to too flourish VIA-2291;
-- our comprehension to form and maintain collaborative relationships to progress and commercialize our product candidates;
-- accepted economic and employment conditions; and
-- the other risks described under Oppose IA "Risk Factors" in our Annual Announcement on Form 10-K for the fiscal year ended Dec 31, 2008 on data with the SEC.
All forward-looking statements attributable to us or people acting on our behalf are largely equipped in their entirety by the cautionary statements set forth above. Forward-looking statements state sole as of the hour they are made, and VIA undertakes no debt to update publicly any of these statements in light of current enlightenment or forthcoming events.
Source: VIA Pharmaceuticals, Inc
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