- Top Line Data Expected soon after CEA Trial data reports in third quarter
SAN FRANCISCO, May 15 /PRNewswire-FirstCall/ -- VIA Pharmaceuticals, Inc. (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 acute coronary syndrome (ACS) study. The ACS study is one of three Phase 2 trials investigating VIA-2291, the company's lead product candidate in cardiovascular disease.
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 (MACE) associated with inflammation, including heart attack and stroke.
"Completing enrollment in our second Phase 2 study is an important milestone for the company, and also represents the largest number of patients we have enrolled in a clinical trial to date," said Lawrence K. Cohen, PhD, chief executive officer of VIA Pharmaceuticals. "This trial will provide important data on VIA-2291's effect in the target population, patients with recent heart attack or unstable angina, and we remain on track to deliver data from this key trial later this year."
The ACS study, which enrolled 191 patients, is designed to establish dose and safety data in patients with ACS who have experienced a recent heart attack or unstable angina. The study includes measures of leukotrienes, biomarkers of inflammation, as well as medical imaging of the coronary vessels to evaluate the impact on plaque characteristics in a subset of patients. Patients in the study are treated once daily with one of three dose levels of VIA-2291 or placebo. "We are very pleased to close enrollment at 191 patients versus our target enrollment of 200 patients as a result of seeing fewer patients fall out of treatment than we initially expected when the trials were designed," said Dr. Rebecca Taub, senior vice president of research and development.
This is the second Phase 2 study of VIA-2291 to complete enrollment. In March 2008, VIA announced completion of enrollment in its Carotid Endarterectomy (CEA) trial, which is designed to provide direct evaluation of VIA-2291's effect on inflammation by analyzing plaque removed from the carotid arteries in patients treated with VIA-2291 or placebo. Enrollment in the third Phase 2 clinical trial, the FDG-PET Trial, is ongoing. Endpoints in this study include reduction in carotid 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 report top line results from the ACS trial soon after top line CEA study results are presented in the third quarter.
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 Item IA "Risk Factors" in our Annual
Report on Form 10-K for the fiscal year ended December 31, 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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