VIA Pharmaceuticals Expands Clinical Trial For VIA-2291 In Acute Coronary Syndrome
Clinical Trial For VIA-2291
VIA Pharmaceuticals will soon initiate a third Phase II clinical trial for VIA-2291, its lead compound. VIA-2291 targets inflammation in the blood vessel wall, an underlying cause of atherosclerosis and its complications, including heart attack and stroke. The new trial design utilizes Positron Emission Tomography with fluorodeoxyglucose tracer (FDG-PET) to measure the impact of VIA-2291 on reducing vascular inflammation in treated patients.
The Company plans to enroll approximately 50 patients following an acute coronary syndrome event into a 24 week randomized, double blind, placebo- controlled study. Endpoints in the study will include reduction in plaque inflammation as measured with FDG-PET, as well as assessment of standard biomarker measurements of inflammation.
VIA is collaborating on the study with Michael Farkouh, M.D. and Zahi Fayad, Ph.D. of Mount Sinai Heart in New York City, and Ahmed Tawakol, M.D. of Massachusetts General Hospital in Boston.
"VIA-2291 could provide a novel approach to addressing inflammation in coronary artery disease," said Adeoye Olukotun, MD, chief medical officer of VIA. "This trial is an excellent example of utilizing the benefits of new imaging technology to help accelerate the development of potentially break- through drugs. The use of state-of-the art FDG-PET imaging technology provides an ideal methodology for measuring the effect of VIA-2291 on reducing vascular inflammation in atherosclerosis."
Larry Cohen, Ph.D., president and chief executive officer of VIA added, "The expansion of the VIA-2291 clinical program with this third trial represents continued progress for VIA in the development of this promising drug candidate. We are on schedule to report the results of our two initial Phase II trials by mid-2008."
Earlier this month VIA announced that the independent Data Safety Monitoring Board (DSMB) for its two concurrent Phase II clinical trials observed a continued acceptable safety profile and evidence of a consistent pharmacological effect of VIA-2291, as would be predicted given its proposed mechanism of action.
VIA's lead product candidate, VIA-2291, is a small molecule drug that targets inflammation in the blood vessel wall, a primary disease process in atherosclerosis. VIA-2291 is a potent, selective and reversible inhibitor of 5-LO, which is a key enzyme in the biosynthesis of leukotrienes (important mediators of inflammation involved in the development and progression of atherosclerosis). VIA-2291 is being developed as a once-daily, oral drug to target inflammation in the blood vessel wall, thereby potentially decreasing the risk of major adverse cardiovascular events (MACE), including heart attack and stroke. According to the American Heart Association, 15.8 million patients in the U.S. have coronary artery disease.