Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.VIA Pharmaceuticals has enrolled the first patient in its Phase II clinical trial that utilizes Positron Emission Tomography with fluorodeoxyglucose tracer to measure VIA-2291's ability to reduce vascular inflammation in treated patients. The company also provided a comprehensive update of its VIA-2291 Phase II clinical program.
Subscribe to our email newsletter
VIA-2291 is a potent small molecule drug that targets inflammation in the blood vessel wall, a primary disease process in atherosclerosis. The Phase II clinical program’s innovative trial designs are intended to provide new visibility to the role of inflammation in cardiovascular disease and the potential of VIA-2291 to address vascular inflammation.
The FDG-PET trial is enrolling approximately 50 patients following a heart attack into a 24 week randomized, double blind, placebo-controlled study. Enrollment is expected to be complete during 2008 and data is expected in the first half of 2009. Endpoints in the study include reduction in plaque inflammation following dosing with VIA-2291 as measured with FDG-PET, as well as assessment of standard biomarker measurements of inflammation.
VIA has enrolled approximately 40 patients in the Carotid Endarterectomy (CEA) study as planned, and is expanding enrollment to gather additional data by taking advantage of additional patients currently in the screening and patient recruitment process. VIA plans to enroll approximately 50 patients and expects to report data in the third quarter of 2008 from this study. The CEA study is designed to evaluate the efficacy of VIA-2291 in the vessel wall, and has the unique advantage of providing access to atherosclerotic tissue for direct evaluation of VIA-2291’s effect on inflammation, through a panel of assays and histological examinations.
The Acute Coronary Syndrome (ACS) study has enrolled more than two-thirds of the targeted 200 patients for this trial and top-line data results are anticipated to be released shortly after the release of data from the CEA trial. This study is designed to establish dose and safety data in patients with acute coronary syndrome (ACS) who have experienced a recent heart attack, and includes measures of leukotrienes, biomarkers of inflammation as well as medical imaging of the coronary vessel wall to evaluate impact on plaque characteristics.
Lawrence Cohen, CEO of VIA Pharmaceuticals, said: “The continued momentum in our Phase II clinical program and the robustness of the trial designs put us on track to deliver critical proof-of-concept data for VIA-2291 later in 2008.”