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Corautus Genetics Commences GENASIS Phase IIb Clinical Trial for
Severe Cardiovascular Disease
ATLANTA, Sept. 8 /PRNewswire-FirstCall/ -- Corautus Genetics Inc. (AMEX:CAQ)
today announced the commencement of its Phase IIb clinical trial to evaluate
the safety and efficacy of Vascular Endothelial Growth Factor-2 (VEGF-2) for
the treatment of severe cardiovascular disease. Corautus has named this
clinical trial GENASIS for "Genetic Angiogenic Stimulation Investigational
Study."
The randomized, double-blinded, dose-ranging and placebo-controlled study will
enroll up to 404 patients with Class III or IV angina in approximately 20
cardiac medical centers in the United States. Angina results from coronary
artery disease and manifests as chest pain due to a lack of adequate oxygen
supply to the heart muscle. Class III and IV angina are the most severe forms
of this condition, affecting more than one-third of the 400,000 newly diagnosed
cases in the United States each year. The GENASIS trial will evaluate the
efficacy and safety of defined doses of VEGF-2 delivered percutaneously via the
Boston Scientific Corporation (NYSE:BSX) Stiletto(TM) endocardial direct
injection catheter system.
The first patient in the clinical trial was treated by Dr. Douglas W. Losordo,
Chief of Cardiovascular Research at Caritas St. Elizabeth's Medical Center in
Boston, who commented, "We are pleased to be participating in the GENASIS
trial, which is the only study of this magnitude now available in the U.S.
Currently, this patient population has no available treatment for a
debilitating condition known as refractory myocardial ischemia. The findings
of the previous clinical trials with VEGF-2 for severe cardiovascular disease
were quite encouraging, and we look forward to the results of this new trial."
Richard E. Otto, President and CEO of Corautus Genetics, commented, "The
commencement of the GENASIS study is an important milestone for Corautus and
the culmination of the efforts of many people over many years, starting with
the vision of the late Dr. Jeffrey Isner, who began research in this area at
Caritas St. Elizabeth's in the late 1990's. We are especially fortunate to have
Dr. Losordo, who assisted Dr. Isner in the earlier trials, as our lead national
principal investigator for the new trial."
In its most recently published data regarding cardiovascular disease in the
United States, the American Heart Association reports cardiovascular disease is
the leading cause of death representing approximately 38.5% of all deaths in
2001. Further, cardiovascular disease claims more lives each year than the
next five leading causes of death combined. The American Heart Association
estimates that 54% of all deaths from cardiovascular disease are attributable
to coronary artery disease.
Coronary artery disease is a condition characterized by a narrowing of the
coronary arteries and reduced blood flow, and therefore oxygen, to the heart.
The lack of blood flow and oxygen to an organ is referred to as ischemia, and
myocardial ischemia refers to the lack of blood flow and oxygen to the heart
muscle. The American Heart Association estimates that more than 13 million
Americans have coronary artery disease.
The primary symptoms of coronary artery disease and myocardial ischemia include
heart attack and angina, the medical term for chest pain or discomfort due to
myocardial ischemia. Class III angina is characterized by a marked limitation
of ordinary physical activity. The most severe class of angina, Class IV, is
characterized by an inability to carry on any physical activity without
discomfort.
The American Heart Association estimates that approximately 6,800,000 coronary
patients in the United States have angina. Of these patients with angina,
approximately 150,000 to 250,000 (Class III and IV angina) coronary artery
disease patients annually are considered refractory, which means they cannot be
successfully treated with conventional cardiovascular therapies. In most
cases, these patients have undergone multiple invasive procedures and/or
surgeries that have been unsuccessful. Corautus has targeted this critical
patient population as the initial candidates for its VEGF-2 gene therapy
treatment.
About the Technology
VEGF-2 is a growth factor that is believed to promote the development of
supplemental collateral blood vessels, a process known as therapeutic
angiogenesis. In the Phase IIb trial for severe cardiovascular disease, VEGF-
2 is delivered to the ischemic tissue in the heart muscle in the form of naked
DNA plasmid, a non-viral vector. 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 expects to
see the effect of the expression of DNA-encoded VEGF-2, which in turn
stimulates the growth of new blood vessels by promoting the migration and
proliferation of endothelial cells in the heart.
About Corautus Genetics Inc.
Corautus Genetics Inc. is a clinical-stage biopharmaceutical company dedicated
to the development of gene transfer therapy products for the treatment of
severe cardiovascular and peripheral vascular disease. Corautus is currently
developing and testing a gene transfer product using the Vascular Endothelial
Growth Factor-2 (VEGF-2) gene to promote therapeutic angiogenesis in ischemic
muscle. In July 2003, Corautus entered into 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 Boston Scientific Corporation
Boston Scientific is a worldwide developer, manufacturer and marketer of
medical devices whose products are used in a broad range of interventional
medical specialties. For more information, please visit:
http://www.bostonscientific.com/ .
About Caritas St. Elizabeth's Medical Center
Caritas St. Elizabeth's Medical Center is a major academic medical center
affiliated with Tufts University School of Medicine. Centers of excellence
include cardiology and cardiovascular research, neurology, women's health and
high-risk obstetrics, cancer care, orthopedics, pulmonary medicine and
gastroenterology. Caritas St. Elizabeth's is a member of Caritas Christi
Health Care, the second largest health care system in New England.
Forward-Looking Statement
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 future
results of operations or our financial condition, benefits from the alliance
with Boston Scientific, research, development and commercialization of our
product candidates, and in particular 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 the
year ended December 31, 2003 (File No. 001-15833) filed March 30, 2004, which
are incorporated by reference into this press release.
CONTACT: Investor Relations, Jack W. Callicutt of Corautus Genetics Inc.,
+1-404-526-6200, or fax, +1-404-526-6218; and Media Relations, Justin Jackson
of Burns McClellan, on behalf of Corautus Genetics Inc., +1-212-213-0006
DATASOURCE: Corautus Genetics Inc.
CONTACT: Investor Relations, Jack W. Callicutt of Corautus Genetics
Inc., +1-404-526-6200, or fax, +1-404-526-6218; or Media Relations, Justin
Jackson of Burns McClellan, +1-212-213-0006, for Corautus Genetics Inc.
Web site: http://www.corautus.com/
http://www.bostonscientific.com/