Trial To Measure Impact Of VIA-2291 To Reduce Vascular Inflammation
VIA Pharmaceuticals has enrolled the first patient in its Phase 2 clinical trial that utilizes Positron Emission Tomography with fluorodeoxyglucose tracer (FDG-PET) 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 2 clinical program.
VIA-2291 is a potent small molecule drug that targets inflammation in the blood vessel wall, a primary disease process in atherosclerosis. It is being developed as a once-daily, oral drug to potentially decrease the risk of major adverse cardiovascular events associated with inflammation, including heart attack and stroke. The FDG-PET trial is one of three concurrent, ongoing Phase 2 trials testing VIA-2291 in a variety of clinical settings. The Phase 2 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 continued momentum in our Phase 2 clinical program and the robustness of the trial designs put us on track to deliver critical proof-of-concept data for VIA-2291 later this year," said Lawrence K. Cohen, PhD, chief executive officer of VIA Pharmaceuticals. "Inflammation is the root cause of cardiovascular disease and there remains a significant unmet need to address the major adverse events, including heart attack and stroke, associated with this disease. Despite currently available medications that treat the conditions that increase the risk of these events, these therapies do not treat the underlying inflammation."
The company provided the following specific update for each of its three Phase 2 clinical trials:
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. The use of state-of-the art FDG-PET imaging technology provides a new and important methodology for measuring the effect of VIA-2291 in reducing vascular inflammation.
"We are pleased with the progress of our clinical program and the commencement of our third Phase 2 trial to directly demonstrate the impact of VIA-2291 on inflammation in patients with advanced atherosclerotic disease," said Adeoye Olukotun, MD, chief medical officer of VIA. "The data from this study, in combination with our other two trials, is designed to directly assess the safety, mode of action and clinical activity of VIA-2291 to reduce vascular inflammation, and therefore, the risk of major adverse cardiovascular events."