SAN FRANCISCO, April 4, 2008 /PRNewswire-FirstCall/ -- VIA Pharmaceuticals (Nasdaq: VIAP), a biotechnology company focused on the development of compounds for the treatment of cardiovascular disease, announced today that the independent Data Safety Monitoring Board (DSMB) for its VIA-2291 Phase 2 clinical trial program recently met to review patient safety for its current Phase 2 studies. The DSMB observed a continued acceptable safety profile of VIA-2291 and recommended VIA continue its ongoing trials as planned.
"We are encouraged by the continued positive safety profile of VIA-2291 as we enroll more patients in our Phase 2 clinical program," said Adeoye Olukotun, M.D., chief medical officer for VIA Pharmaceuticals. "We believe that a drug that reduces inflammation, an underlying cause of atherosclerosis and complications including heart attack and stroke, would help to address a significant unmet medical need."
VIA recently announced enrollment completion of its Phase 2 carotid endarterectomy (CEA) trial and expects to present top-line results in the third quarter of 2008. 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. Patient enrollment continues in the FDG-PET study, the company's third Phase 2 clinical trial.
"With the recent completion of our CEA trial enrollment, and this positive DSMB recommendation, we continue to make significant progress with our Phase 2 clinical program, and remain on track to deliver our first proof of concept data later this year," said Lawrence K. Cohen, Ph.D., chief executive officer of VIA Pharmaceuticals.
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|
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