Corautus Genetics Receives FDA Fast Track Designation for VEGF-2
03 11월 2005 - 10:02PM
PR Newswire (US)
ATLANTA, Nov. 3 /PRNewswire-FirstCall/ -- Corautus Genetics Inc.
(NASDAQ:VEGF), a clinical stage biopharmaceutical company, today
announced that the U.S. Food and Drug Administration ("FDA") has
granted Fast Track designation to Corautus for Vascular Endothelial
Growth Factor 2 ("VEGF-2") for the treatment of severe angina
associated with cardiovascular disease. "The FDA's decision to
grant Fast Track designation to our VEGF-2 program is a significant
milestone in the clinical development of our therapeutic to treat a
large patient population with unmet medical needs," stated Richard
E. Otto, President and Chief Executive Officer of Corautus.
"Receiving this Fast Track designation is another step in our
regulatory strategy that is designed to afford us the opportunity
to accelerate the development of VEGF-2 to commercialization." Mr.
Otto continued, "The Fast Track application was submitted based
upon the large unmet medical need that our VEGF-2 program
addresses. Severe angina resulting from coronary artery disease is
a serious, debilitating and potentially life threatening disease.
We are pleased the FDA determined that our VEGF-2 program warranted
this designation, and we looking forward to working with FDA to
advance our clinical strategy." Under the FDA Modernization Act of
1997, the Fast Track program was created to facilitate the
development and expedite the review of new therapeutics that are
intended to treat serious or life threatening diseases, and that
demonstrate the potential to address unmet medical needs. Fast
Track designated therapeutics are eligible for priority review (6
months versus the average 12 months) and/or the review of portions
of the marketing application prior to the completion of the final
registration package. Corautus' GENASIS (GENetic Angiogenic
Stimulation Investigational Study) clinical trial is the largest
cardiovascular study of its kind and is evaluating the safety and
efficacy of VEGF-2 for the treatment of severe angina associated
with cardiovascular disease. 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 is currently developing and testing a gene transfer
product using the VEGF-2 gene to promote therapeutic angiogenesis
in ischemic muscle. In July 2003 Corautus entered into a strategic
alliance with Boston Scientific Corporation (NYSE:BSX) to develop,
commercialize and distribute the VEGF-2 gene therapy products. For
more information, please visit http://www.corautus.com/.
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 projections about our ongoing
clinical trial, including its cost, statements about and potential
benefits from FDA Fast Track designation, projections about our
future results of operations or our financial condition, benefits
from the alliance with Boston Scientific, benefits from
manufacturing agreements, research, development and
commercialization of our product candidates, sufficient and timely
enrollment of suitable patients in our clinical trial, whether
early-stage clinical trial results are any indication of results in
subsequent clinical trials, 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' Annual
Report on Form 10-K for 2004 filed on March 22, 2005, which are
incorporated by reference into this press release. All
forward-looking statements included in this press release are based
on information available to Corautus on the date hereof, and
Corautus assumes no obligation to update such forward-looking
statements. CONTACTS: Corautus Genetics Inc. Lippert/Heilshorn
& Associates Michael K. Steele Kim Golodetz () (404) 526-6212
(212) 838-3777 Bruce Voss () (310) 691-7100 DATASOURCE: Corautus
Genetics Inc. CONTACT: Michael K. Steele of Corautus Genetics Inc.,
+1-404-526-6212, or ; or Kim Golodetz, +1-212-838-3777, or , or
Bruce Voss, +1-212-838-3777, or , both of Lippert-Heilshorn &
Associates Web site: http://www.corautus.com/
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