Corautus Genetics Inc. Announces Developments in Clinical Trial and Public Offering
14 3월 2006 - 10:31PM
PR Newswire (US)
ATLANTA, March 14 /PRNewswire-FirstCall/ -- Corautus Genetics Inc.
(NASDAQ:VEGF) today announced that in conjunction with Boston
Scientific Corporation (NYSE:BSX), it has temporarily suspended
patient treatments in its Phase IIb clinical trial (the "GENASIS"
trial). In the trial, Corautus uses Boston Scientific's
Stiletto(TM) endocardial direct injection catheter system to
deliver its investigational VEGF-2 biologic for the treatment of
severe angina. To date, Corautus has treated 295 of the 404
patients scheduled to be included in the trial. Boston Scientific
requested the voluntary suspension yesterday, as a result of three
recently reported serious adverse events ("SAEs") of pericardial
effusion, which do not appear to be related to the VEGF-2 biologic.
Pericardial effusion is a condition characterized by excess fluid
in the pericardial sac that surrounds the heart. The percentage of
cases requiring further intervention due to pericardial effusion in
the GENASIS trial to date has been 1.37 percent. Richard Otto,
President and Chief Executive Officer of Corautus, stated, "While
our clinical trial has been through its third and final scheduled
safety review by our independent Data Monitoring Committee and we
are nearing completion of enrollment, safety issues always take
precedence. Boston Scientific has requested a short period to
review these latest SAEs, and we have accommodated their request.
Boston Scientific has been an excellent and quality collaborator
throughout this trial, and they have pledged an expeditious and
thorough review of any issues identified on the catheter system or
its use in our trial. We look forward to resumption of treatment of
the remaining patients in the GENASIS trial." As a result of the
voluntary suspension of the use of the Stiletto catheter, Corautus
and its underwriters have mutually agreed to terminate Corautus'
previously announced public offering of common stock. Mr. Otto
concluded, "We remain confident in our development plans for our
VEGF-2 biologic as a potential treatment for severe angina. We will
aggressively work to resolve the issues raised by these
developments and provide additional information when it is
available. We closed 2005 with $30.9 million in cash and short-term
investments, which provides us with sufficient flexibility to
continue our development programs. We will continue to evaluate
financing alternatives for the Company and may seek to raise
additional capital in the future." Corautus will webcast a
conference call at 10:00 am EST today, March 14, 2006, to discuss
this release. To access the live webcast, please log on to the
Company's website at http://www.corautus.com/ and go to the
Investor Relations section. Alternatively, domestic callers may
participate in the conference call by dialing (866) 713-8565, and
international callers may participate in the conference call by
dialing (617) 597-5324. The access code for the conference call is
"Corautus." Webcast and telephone replays of the conference call
will be available approximately two hours after the completion of
the call through May 14, 2006. Domestic callers can access the
replay by dialing (888) 286-8010, and international callers can
access the replay by dialing (617) 801-6888; the PIN access number
is 84228264. 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 which address operating
performance, events or developments that we expect or anticipate
will occur in the future, such as reviews of data by the Data
Monitoring Committee, projections about our ongoing clinical trial,
including its costs, potential benefits from manufacturing
agreements, the potential benefits from previous clinical trials,
sufficient and timely enrollment of suitable patients in our
clinical trial, 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,
manufacture of sufficient and acceptable quantities of our proposed
products, approval of our product candidates, 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' 2004
Annual Report on Form 10-K which was filed on March 22, 2005, which
are incorporated by reference into this press release. CONTACTS:
Michael K. Steele Corautus Genetics Inc. 404-526-6212 Kim Golodetz
Lippert/Heilshorn & Associates 212-838-3777 Bruce Voss
Lippert/Heilshorn & Associates 310-691-7100 DATASOURCE:
Corautus Genetics Inc. CONTACT: Michael K. Steele of Corautus
Genetics Inc., +1-404-526-6212, ; or Kim Golodetz, +1-212-838-3777,
, or Bruce Voss, +1-310-691-7100, , both of Lippert/Heilshorn &
Associates Web site: http://www.corautus.com/
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