VIA Pharmaceuticals Completes Patient Visits in Phase 2 Trial of VIA-2291
Trial Utilizes Positron Emission Tomography with Flurodeoxyglucose Tracer (FDG-PET) Non Invasive Imaging
SAN FRANCISCO, Dec 03, 2009 /PRNewswire-FirstCall via COMTEX News Network/ -- VIA Pharmaceuticals, Inc. (Nasdaq: VIAP), a biotechnology company focused on the development of compounds for the treatment of cardiovascular and metabolic disease, today announced that it has completed the last patient visit in its Phase 2 FDG-PET clinical trial of VIA-2291.
The FDG-PET trial enrolled 52 patients and was carried out at five sites in the US and Canada including Massachusetts General Hospital, Mount Sinai School of Medicine, University of Massachusetts, Winthrop University Hospital and Montreal Heart Institute. The study is designed to measure the impact of VIA-2291 on reducing inflammation in carotid plaque in treated patients. Patients were enrolled following an acute coronary syndrome event, such as heart attack or stroke, into the 24 week, randomized, double blind, placebo-controlled study. Endpoints in the study include reduction in atherosclerotic plaque inflammation as measured by serial FDG-PET scans. Completion of the data analysis and presentation of clinical trial results are anticipated in early 2010.
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 by reducing inflammation in plaque, which is 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. For more information, visit: http://www.viapharmaceuticals.com.
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 comply with the NASDAQ rules for continued
listing in order to maintain the listing of our common stock
on NASDAQ;
-- our ability to obtain necessary financing in the near term,
including amounts necessary to repay the loan from Bay City Capital
by the December 31, 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 timely recruit and enroll patients in any
future clinical trials;
-- 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 cardiometabolic
clinical trials using surrogate endpoints in Phase 1 and Phase
2 clinical trials which may differ from the ultimate endpoints
required for registration of a candidate drug;
-- 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, interpreted differently by
regulatory authorities or negated 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 Reports on Form 10-Q for
the quarters ended March 31, 2009, June 30, 2009 and
September 30, 2009, each 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.
http://www.viapharmaceuticals.com
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