VIA Pharmaceuticals Announces Positive Phase 2 Results Of VIA-2291 In Cardiovascular Patients Using Serial MDCT Imaging Of Coronary Plaque
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VIA Pharmaceuticals, Inc. (Nasdaq: VIAP) announced the results of a sub-study of patients in its acute coronary syndrome (ACS) Phase 2 trial who received serial 64 slice multidetector computed tomography (MDCT) scans before and after six months of treatment with its govern drug, VIA-2291, an inhibitor of leukotrienes, proposed mediators of vascular inflammation. Results were presented in a poster session at the American Heart Collection Arteriosclerosis, Thrombosis and Vascular Biology (ATVB) Annual Conference 2009 in Washington, D.C. by Jean-Claude Tardif MD, of the Montreal Passion Institute, and Dr. Rebecca Taub, VIA's Senior Vice Head of the state - Probation & Development.
Of 191 patients enrolled in the inaugural 12 weeks of the ACS trial, over 85 elected to live on in the recite for an more 12 weeks, receiving either placebo or VIA-2291 on top of current principles medical care. Everyone of these patients received an MDCT scan at baseline and at 24 weeks. Evaluable scans from patients treated with placebo showed significantly exceeding evidence of inexperienced plaque lesions at follow-up than VIA-2291 treated patients. MDCT scans of patients with low density plaques demonstrated statistically significant, lower plaque volumes in combined VIA treated groups compared to placebo. In sync these results propose that VIA-2291 may diminish the succession of unstable coronary plaques that lead to affection attacks and stroke.
Despite advances in treatment, cardiovascular disease remains a substantial cause of death and disability in the United States and the world. Emerging trial points to the dormant for inflammation within the vascular wall to be a key contributing factor in major adverse cardiac events (MACE) such as emotions attack or stroke. This ACS sub-study is the first clinical trial to convenience MDCT imaging to assess the effects of a narcotic on coronary plaque in a great patient cohort. MDCT is a state-of-the-art imaging technology that enables non-invasive imaging of coronary vessels.
"This innovative imaging technology has, for the cardinal time, allowed us to visually and non-invasively show a diminution in plaque textbook and a reduced numeral of brand-new plaque lesions," said Dr. Jean-Claude Tardif, Employer of the Montreal Heart Institute Test Centre, professor of medicine at the University of Montreal and principal investigator of the VIA-2291 ACS trial. "In the ACS study results presented in 2008, we discussed VIA-2291's knack to reduce big sensitivity C-reactive protein (hs-CRP), a biomarker for inflammation. Taken as a whole, these results are an crucial step forward in compassionate the consequence of one cardiovascular inflammatory pathway."
"VIA-2291 continues to expo a expressing development on vascular inflammation, and these data add to the weight of the evidence from our Leaf 2 test program," said Lawrence K. Cohen, Ph.D., manager executive officer of VIA. "We annex now combined histology, non-invasive imaging and biomarker facts to demonstrate the pressure of VIA-2291. This adds support to our clinical adding to efforts and gives us still more advantageous confidence as we look to move into in a larger trial."
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 the blood vessel wall, which is an underlying grounds of atherosclerosis and its complications, including feelings defilement 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 proceeds may encompass "forward-looking" statements within the bearing of the Private Securities Litigation Change Act of 1995. These statements relate to impending events or to VIA's coming financial performance and involve hackneyed and anonymous risks, uncertainties and other factors that may cause VIA's actual results, levels of activity, performance or achievements to be materially different from any time to come results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. In some cases, you can spot forward-looking statements by the account of paragraph such as "may," "could," "expect," "intend," "plan," "seek," "look to," "anticipate," "believe," "estimate," "predict," "potential," "continue" or the negative of these terms or other similar terminology. You should not place undue reliance on forward-looking statements because they embrace acknowledged and concealed risks, uncertainties and other factors which are, in some cases, beyond VIA's control and which could materially induce actual results, levels of activity, performance or achievements.
Factors that may create actual results to differ materially from current expectations include, however are not limited to:
-- our ability to borrow further amounts under the loan from Bay Metropolis Capital, which is words to the discretion of Bay Municipality Capital;
-- our authority to achieve required financing in the near term, including amounts vital to answer the loan from Bay City Capital by the Sept 14, 2009 maturity period (or earlier provided 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 Conurbation Capital;
-- our ability to maintain the listing of our popular inventory on NASDAQ;
-- our failure to timely levy and enrol patients for the FDG-PET clinical trial, as fine as any forthcoming clinical trial;
-- our failure to earn 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 all 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 very review and analysis, are revised or negated by authorities or by next folio clinical trials;
-- our ability to cop necessary FDA approvals, including to originate coming clinical trials of VIA-2291 (such as a Phase IIb trial or Chapter III registration trial);
-- our bent to successfully commercialize VIA-2291;
-- our ability to obtain and protect our intellectual belongings related to our product candidates;
-- our potential for approaching career and the course of our product pipeline, including the THR beta agonist candidate and the other compounds licensed from Roche;
-- our capability to obtain strategic opportunities to companion and cooperate with booming biotechnology or pharmaceutical companies to further enroot VIA-2291;
-- our potency to form and maintain collaborative relationships to age and commercialize our product candidates;
-- general economic and event conditions; and
-- the other risks described under Effects IA "Risk Factors" in our Annual Announcement 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 humans acting on our behalf are largely qualified in their entirety by the cautionary statements allot forth above. Forward-looking statements assert only as of the generation they are made, and VIA undertakes no obligation to refresh publicly any of these statements in light of cutting edge counsel or ultimate events.
Source: VIA Pharmaceuticals, Inc
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