Corautus Genetics Announces Final Efficacy Results of GENASIS Phase IIb Clinical Trial
10 10월 2006 - 10:00PM
PR Newswire (US)
ATLANTA, Oct. 10 /PRNewswire-FirstCall/ -- Corautus Genetics Inc.
(NASDAQ:VEGF), a clinical stage biopharmaceutical company,
announced today that the final efficacy results from its GENASIS
Phase IIb clinical trial did not achieve a statistically
significant difference from placebo in any active dose group for
the primary efficacy endpoint. The primary efficacy endpoint in the
GENASIS clinical trial was an improvement of at least one minute in
exercise tolerance time ("ETT") from baseline to three months. The
data indicated considerable overlap in results between the active
and placebo groups for the secondary endpoints as well, and no
clear dose effect was seen. "The final efficacy results proved to
be consistent with the preliminary data reviewed earlier this year
by the independent Data Monitoring Committee (DMC) and as reported
in our release of April 10, 2006," said Richard Otto, President and
Chief Executive Officer of Corautus. "At that time, the DMC
reviewed summary ETT data on 220 patients and recommended that
enrollment in the GENASIS trial be terminated, a recommendation
that Corautus accepted. When the trial was terminated, 295 patients
had been enrolled. As reported in our release of July 13, 2006, we
planned, and subsequently implemented, locking the database on
those patients and began the complete efficacy analysis of both
primary and secondary endpoints. The final data from the trial has
now been received and studied." "The placebo effect was much more
significant and was sustained longer than was anticipated in the
design of the GENASIS trial. In general, a majority of patients in
all treatment arms (active and placebo) significantly improved from
their baseline status in both primary and secondary efficacy
endpoints; however, there was no significant separation from the
placebo in any active dose group." "We would like to thank both
patients and investigators for their support and participation in
this clinical development program for a disease that still
represents a large unmet medical need," said Mr. Otto. Mr. Otto
continued, "We continue to support Phase I clinical trials
involving VEGF-2 for both diabetic neuropathy and critical limb
ischemia, but we have also actively focused recent efforts on
identifying additional therapeutic development opportunities for
Corautus via in-license, merger or acquisition. On September 30,
2006, we had approximately $19.7 million in cash and short-term
investments in addition to our intangible assets of people,
organizational structure, and experience. We intend to deploy our
assets in programs and opportunities that will build long-term
shareholder value." About Corautus Genetics Corautus Genetics is a
clinical-stage biopharmaceutical company dedicated to the
development of gene transfer therapy products for the treatment of
cardiovascular (severe angina) and peripheral vascular disease.
Corautus has been developing a gene therapy product candidate using
the VEGF-2 gene to promote therapeutic angiogenesis in ischemic
muscle. Corautus has a strategic alliance with Boston Scientific
Corporation to develop, commercialize and distribute the VEGF-2
gene therapy products. For more information, please visit
http://www.corautus.com/. About GENASIS GENASIS was a randomized,
double-blind, dose-ranging and placebo controlled Phase IIb
clinical trial, which treated 295 patients with Class III or IV
angina that were not suitable candidates for traditional
revascularization procedures. The GENASIS trial was conducted in
approximately 30 leading cardiac medical centers throughout the
United States. In the GENASIS trial, defined doses of VEGF-2 in the
form of "naked" plasmid DNA, a non-viral delivery vector, were
delivered to diseased heart muscle tissue via the Boston Scientific
Corporation Stiletto(TM) endocardial direct injection catheter
system. The injection procedure was performed by a cardiologist in
a standard cardiac catheterization laboratory. VEGF-2 is a
naturally occurring growth factor that is believed to promote the
development of supplemental collateral blood vessels, a process
known as therapeutic angiogenesis. Once administered, the DNA
plasmid appears to be taken up and expressed by myocardium near the
injection site. Inside the cell, the DNA plasmid then enters the
nucleus of the cell without a requirement of incorporation into the
genomic DNA. The Phase IIb clinical trial was designed to determine
the effect of the expression of DNA-encoded VEGF-2, which in turn
is believed to stimulate the growth of new blood vessels by
promoting the migration and proliferation of endothelial cells in
the heart. Forward-Looking Statements This press release may
contain forward-looking statements made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995.
Such statements are subject to certain factors, risks and
uncertainties that may cause actual results, events and
performances to differ materially from those referred to in such
statements. These risks include statements that address the results
of our clinical trial, the ability to identify and secure rights to
new therapeutic development opportunities, operating performance,
events or developments that we expect or anticipate will occur in
the future, future results of operations or our financial
condition, adequacy of funding, benefits from the alliance with
Boston Scientific, research, development and commercialization of
our product candidates, anticipated trends in our business, meeting
additional capital requirements, and other risks that could cause
actual results to differ materially. These risks are discussed in
Corautus Genetics Inc.'s Securities and Exchange Commission
filings, including, but not limited to, the risk factors in
Corautus' 2005 Annual Report on Form 10-K which was filed on March
20, 2006 amended by Corautus' Form 10-Q for the period ended March
31, 2006 which was filed on May 15, 2006. All forward-looking
statements included in this document are based on information
available to Corautus on the date hereof, and Corautus assumes no
obligation to update any such forward-looking statements. CONTACTS:
Corautus Genetics Inc. Michael K. Steele (404) 526-6212 DATASOURCE:
Corautus Genetics Inc. CONTACT: Michael K. Steele of Corautus
Genetics Inc., +1-404-526-6212, or Web site:
http://www.corautus.com/
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