VIA Pharmaceuticals Meets With FDA To Discuss Next Steps For VIA-2291 And Phase 3 Outcome Trial In Cardiovascular Disease
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VIA Pharmaceuticals, Inc. (Nasdaq: VIAP), a biotechnology company focused on the development of compounds for the treatment of cardiovascular and metabolic disease, announced today that an end of Phase 2a meeting for the Company's lead drug, VIA-2291 (atreleuton), was recently held with the U.S. Food and Drug Administration (FDA). The Company reviewed safety and biologic activity data from the VIA-2291 Phase 2 CEA and ACS trials with the FDA and received guidance including suggestions from the Agency on the Company's Phase 3 trial design.
VIA-2291 is a selective and reversible inhibitor of 5 Lipoxygenase, a key enzyme in the biosynthesis of leukotrienes, which are important mediators of the inflammation believed to be involved in the development and progression of atherosclerosis. The Company's Phase 3 cardiovascular outcome study will assess the effect of VIA-2291 in preventing cardiovascular events such as heart attack, stroke and cardiovascular mortality in patients with recent heart attack and/or established atherosclerotic cardiovascular disease. Guidance from the FDA will be incorporated into the VIA-2291 registration and Phase 3 program, and the company intends to submit its proposed Phase 3 plan to FDA including a request for a Special Protocol Assessment. The Company is currently exploring strategic opportunities for launching this final phase of development.
"The current treatment approaches have reached their potential, and yet there still exists a significant unmet medical need in heart disease, particularly in patients at high risk for heart attacks, strokes and cardiovascular death," said Larry Cohen, President and Chief Executive Officer of VIA Pharmaceuticals, Inc. "VIA-2291 specifically targets the inflammation in atherosclerotic plaque that is thought to trigger major adverse cardiac events. Our positive Phase 2 data demonstrate VIA-2291's potent inhibition of leukotrienes, lowering of hsCRP, and the potential for plaque stabilization as demonstrated by reduction in carotid plaque inflammation and non-calcified coronary plaque volume. We believe this compound is now ready for testing in a broad outcome Phase 3 trial that may establish a link between inflammation and reduction of these major adverse cardiac events."
About VIA Pharmaceuticals, Inc.
VIA Pharmaceuticals, Inc. is a biotechnology company focused on the development of compounds for the treatment of cardiovascular and metabolic disease. VIA's lead candidate, VIA-2291, targets a significant unmet medical need: reducing inflammation in plaque, an underlying cause of atherosclerosis and its complications, including heart attack and stroke. In addition, VIA's pipeline of drug candidates includes other compounds to address other underlying causes of cardiovascular disease: high cholesterol, diabetes and inflammation.
Forward Looking Statements
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 borrow additional amounts under the loan from Bay City Capital, which is subject to the discretion of Bay City Capital;
-- our ability to obtain necessary financing in the near term, including amounts necessary to repay the loan from Bay City Capital by the September 14, 2009 maturity date (or earlier if certain repayment acceleration provisions are triggered);
-- our ability to control our operating expenses;
-- our ability to comply with covenants included in the loan from Bay City Capital;
-- our ability to maintain the listing of our common stock on NASDAQ;
-- our failure to timely recruit and enroll patients for the FDG-PET clinical trial, as well as any future clinical trial;
-- our 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;
-- if the results of the ACS and CEA studies, upon further review and analysis, are revised or negated by authorities or by later stage clinical trials;
-- our ability to obtain necessary FDA approvals, including to initiate future clinical trials of VIA-2291;
-- our ability to successfully commercialize VIA-2291;
-- our ability to identify potential clinical candidates from the family of DGAT1 compounds licensed and move them into preclinical development;
-- 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 pipeline, including the THR beta agonist candidate and the other compounds licensed from Roche;
-- our ability to obtain strategic opportunities to partner and collaborate with large biotechnology or pharmaceutical companies to further develop VIA-2291;
-- 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 1A "Risk Factors" in our Annual Report on Form 10-K for the fiscal year ended December 31, 2008, as supplemented by the risks described under Item 1A "Risk Factors" in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2009, 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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