VIA Pharmaceuticals Announces Positive Phase 2 Results of VIA-2291 in Cardiovascular Patients Using Serial MDCT Imaging of Coronary Plaque
Data Presented at American Heart Association ATVB Conference Shows Reduction in Non-Calcified Plaque Volume and Fewer New Plaque Lesions in Treated Patients
Of 191 patients enrolled in the first 12 weeks of the ACS trial, over 85 elected to continue in the study for an additional 12 weeks, receiving either placebo or VIA-2291 on top of current standard medical care. Each of these patients received an MDCT scan at baseline and at 24 weeks. Evaluable scans from patients treated with placebo showed significantly more evidence of new 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. Together these results suggest that VIA-2291 may reduce the progression of unstable coronary plaques that lead to heart attacks and stroke.
Despite advances in treatment, cardiovascular disease remains a leading cause of death and disability in
“This innovative imaging technology has, for the first time, allowed us to visually and non-invasively demonstrate a reduction in plaque volume and a reduced number of new plaque lesions,” said Dr.
“VIA-2291 continues to show a significant effect on vascular inflammation, and these data add to the weight of the evidence from our Phase 2 trial program,” said
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 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.
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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, including to initiate future clinical trials of VIA-2291 (such as a Phase IIb trial or Phase III registration trial); -- 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.
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SOURCE VIA Pharmaceuticals, Inc.