SAN FRANCISCO, March 20 VIA Pharmaceuticals(Nasdaq: VIAP), a biotechnology company focused on the development ofcompounds for the treatment of cardiovascular disease, announced today that ithas completed patient enrollment in its carotid endarterectomy (CEA) study,the first of three Phase 2 trials investigating VIA-2291, the company's leadproduct candidate.
VIA-2291 is a potent small molecule drug that targets inflammation in theblood vessel wall, a primary disease process in atherosclerosis. It is beingdeveloped as a once-daily, oral drug to potentially decrease the risk of majoradverse cardiac events associated with inflammation, including heart attackand stroke.
The CEA study enrolled 50 patients and is designed to provide directevaluation of VIA-2291's effect on inflammation by analyzing plaque removedfrom the carotid arteries of patients treated with VIA-2291 or placebo. CEAis a surgical procedure to remove plaque from the carotid artery to increaseblood flow to the brain in patients with significant blockage in the artery toreduce the risk of stroke. Patients who are diagnosed with carotid arteryblockage are treated for three months with either VIA-2291 or placebo and thenundergo a CEA procedure. The trial will also measure standard serum biomarkersof inflammation to measure reduction of inflammation in treated patients.
"Following analysis of the CEA study data, we expect to have importantdata with respect to VIA-2291's role in reducing vascular inflammation, asmeasured in the carotid plaque tissue," said Rebecca A. Taub, M.D., seniorvice president of research and development of VIA Pharmaceuticals. "Theinnovative design of this trial to study excised carotid plaque tissuefollowing dosing with VIA-2291 provides investigators the ability to use apanel of assays and histological examinations to obtain direct, objectivemeasures of VIA-2291's impact on inflammation."
The Phase 2 program of VIA-2291 includes three concurrent, ongoing trialstesting the compound in a variety of clinical settings. In addition to the CEAstudy, VIA is conducting an Acute Coronary Syndrome (ACS) trial, designed toestablish dose and safety data in patients with acute coronary syndrome whohave experienced a recent heart attack or stroke, and includes measures ofleukotrienes, biomarkers of inflammation as well as medical imaging of thecoronary vessels in a subset of patients, to evaluate the impact of VIA-2291on plaque characteristics. The FDG-PET study is the third Phase 2 clinicaltrial. Endpoints in this study include reduction in plaque inflammationfollowing dosing with VIA-2291 as measured with state-of-the-art FDG-PETimaging technology, as well as assessment of standard biomarker measurementsof inflammation.
VIA expects to present top line CEA Study results in the third quarter ofthis year. Enrollment is also nearing completion for the company's acutecoronary syndrome (ACS) Phase 2 trial and data is expected to follow soonafter the CEA data.
"Completing enrollment in our first Phase 2 study is an importantmilestone for the company," said Lawrence K. Cohen, Ph.D., chief executiveofficer of VIA Pharmaceuticals. "We have developed a comprehensive clinicalstrategy and are on track to deliver our first proof of concept data laterthis year. The information from the CEA, ACS and FDG-PET studies is designedto provide the weight of evidence regarding the effectiveness of VIA-2291 andto support the further development of our lead compound."
VIA-2291 is a selective and reversible inhibitor of 5-LO, which isbelieved to be a key enzyme in the biosynthesis of leukotrienes (importantmediators of inflammation involved in the development and progression ofatherosclerosis). Potentially a complement to current standard of caretherapies that treat risk factors, such as statins, antiplatelet and bloodpressure medications,