- Top Line Data Is Expected to Be Presented in Third Quarter -
SAN FRANCISCO, March 20 /PRNewswire-FirstCall/ -- VIA Pharmaceuticals (Nasdaq: VIAP), a biotechnology company focused on the development of compounds for the treatment of cardiovascular disease, announced today that it has completed patient enrollment in its carotid endarterectomy (CEA) study, the first of three Phase 2 trials investigating VIA-2291, the company's lead product candidate.
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 cardiac events associated with inflammation, including heart attack and stroke.
The CEA study enrolled 50 patients and is designed to provide direct evaluation of VIA-2291's effect on inflammation by analyzing plaque removed from the carotid arteries of patients treated with VIA-2291 or placebo. CEA is a surgical procedure to remove plaque from the carotid artery to increase blood flow to the brain in patients with significant blockage in the artery to reduce the risk of stroke. Patients who are diagnosed with carotid artery blockage are treated for three months with either VIA-2291 or placebo and then undergo a CEA procedure. The trial will also measure standard serum biomarkers of inflammation to measure reduction of inflammation in treated patients.
"Following analysis of the CEA study data, we expect to have important data with respect to VIA-2291's role in reducing vascular inflammation, as measured in the carotid plaque tissue," said Rebecca A. Taub, M.D., senior vice president of research and development of VIA Pharmaceuticals. "The innovative design of this trial to study excised carotid plaque tissue following dosing with VIA-2291 provides investigators the ability to use a panel of assays and histological examinations to obtain direct, objective measures of VIA-2291's impact on inflammation."
The Phase 2 program of VIA-2291 includes three concurrent, ongoing trials testing the compound in a variety of clinical settings. In addition to the CEA study, VIA is conducting an Acute Coronary Syndrome (ACS) trial, designed to establish dose and safety data in patients with acute coronary syndrome who have experienced a recent heart attack or stroke, and includes measures of leukotrienes, biomarkers of inflammation as well as medical imaging of the coronary vessels in a subset of patients, to evaluate the impact of VIA-2291 on plaque characteristics. The FDG-PET study is the third Phase 2 clinical trial. Endpoints in this study include reduction in plaque inflammation following dosing with VIA-2291 as measured with state-of-the-art FDG-PET imaging technology, as well as assessment of standard biomarker measurements of inflammation.
VIA expects to present top line CEA Study results in the third quarter of this year. Enrollment is also nearing completion for the company's acute coronary syndrome (ACS) Phase 2 trial and data is expected to follow soon after the CEA data.
"Completing enrollment in our first Phase 2 study is an important milestone for the company," said Lawrence K. Cohen, Ph.D., chief executive officer of VIA Pharmaceuticals. "We have developed a comprehensive clinical strategy and are on track to deliver our first proof of concept data later this year. The information from the CEA, ACS and FDG-PET studies is designed to provide the weight of evidence regarding the effectiveness of VIA-2291 and to support the further development of our lead compound."
VIA-2291 is a selective and reversible inhibitor of 5-LO, which is believed to be a key enzyme in the biosynthesis of leukotrienes (important mediators of inflammation involved in the development and progression of atherosclerosis). Potentially a complement to current standard of care therapies that treat risk factors, such as statins, antiplatelet and blood pressure medications, VIA-2291 is initially targeted to address the secondary prevention market for patients who have already suffered a major adverse cardiac event, but eventually could be beneficial to the broader 15.8 million patients in the U.S. who have coronary artery disease. VIA has exclusive worldwide rights to develop and commercialize VIA-2291. Based upon prior trials of VIA-2291 in more than 1,100 patients, VIA believes that VIA-2291 will be safe and well tolerated in doses currently being administered in the ongoing clinical trials.
About VIA Pharmaceuticals, Inc.
VIA Pharmaceuticals, Inc. is a biotechnology company focused on the development of compounds for the treatment of cardiovascular disease. VIA is building a pipeline of small-molecule drugs that target 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. The company's lead drug candidate, VIA-2291, is in multiple Phase 2 clinical studies in patients with cardiovascular disease. For more information, visit: http://www.viapharmaceuticals.com.
This press release may contain "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or to VIA's future financial performance and involve known and unknown risks, uncertainties and other factors that may cause VIA's actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. In some cases, you can identify forward-looking statements by the use of words such as "may," "could," "expect," "intend," "plan," "seek," "anticipate," "believe," "estimate," "predict," "potential," "continue" or the negative of these terms or other comparable terminology. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond VIA's control and which could materially affect actual results, levels of activity, performance or achievements.
Factors that may cause actual results to differ materially from current
expectations include, but are not limited to:
-- our ability to obtain necessary financing;
-- our ability to control our operating expenses;
-- our ability to recruit and enroll patients for the ACS and FDG-PET
-- 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;
-- the outcome of any legal proceedings;
-- our ability to obtain necessary FDA approvals;
-- 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
-- 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 the heading "Risk Factors" in our
Quarterly Reports on Form 10-Q for the quarters ended June 30, 2007 and
September 30, 2007 on file with the SEC.
All forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by the cautionary statements set forth above. Forward-looking statements speak only as of the date they are made, and VIA undertakes no obligation to update publicly any of these statements in light of new information or future events.
|SOURCE VIA Pharmaceuticals, Inc.|
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