Chiron Begins Phase III Trial for Tifacogin
18 Mayo 2004 - 8:01AM
PR Newswire (US)
Chiron Begins Phase III Trial for Tifacogin Multicenter,
International Trial Will Study Efficacy in Treatment of Severe
Community-Acquired Pneumonia EMERYVILLE, Calif., May 18
/PRNewswire-FirstCall/ -- Chiron Corporation announced today that
it has initiated a Phase III trial for tifacogin as a treatment for
severe community-acquired pneumonia (severe CAP). Severe CAP is
defined as pneumonia contracted outside of a hospital setting that
requires the patient's admission to an intensive-care unit.
Tifacogin, developed by Chiron, is a recombinant form of tissue
factor pathway inhibitor, or TFPI, a naturally occurring protein in
the body. "The mortality rate associated with severe CAP has
remained constant for the past 50 years in spite of significant
advances in antibiotic therapy. We believe that tifacogin has the
potential to impact this significant unmet medical need," said Dr.
Stephen Dilly, chief medical officer of Chiron BioPharmaceuticals.
"Tifacogin for severe CAP is an excellent fit with our emerging
franchise in serious pulmonary conditions. We have a strong
scientific and clinical rationale for this study, which we believe
is the right study at the right time for tifacogin." The Phase III
study, called CAPTIVATE, is a randomized placebo-controlled study.
The study comprises three treatment arms: placebo, low-dose
tifacogin and higher-dose tifacogin. The study is expected to
accrue approximately 2,100 patients in 200 centers in 16 countries
worldwide. The primary endpoint of the study is reduction in
mortality at 28 days. Severe CAP affects approximately 300,000
patients in the United States annually. Approximately 30 percent of
patients with severe CAP die. Current therapy includes routine
antibiotics and supportive care. No adjunctive drugs are currently
approved for the reduction of mortality in severe CAP. About Chiron
Through its global Blood Testing, Vaccines and BioPharmaceuticals
businesses, Chiron Corporation addresses human suffering with more
than 50 diverse products to detect, prevent and treat disease
worldwide. The company's consistent success has come from its
pioneering science, skill in delivering innovations in
biotechnology and disciplined business approach. Chiron believes
that science has the power to improve people's lives and harnesses
that power to transform public health. This year, Chiron Vaccines
celebrates 100 years of advancing medicine with the anniversary of
two founding companies. In 1904, Emil von Behring and Achille
Sclavo independently started companies in Germany and Italy,
respectively, dedicated to the research, development and
manufacture of vaccines to protect humanity from infectious
disease. As the fifth-largest vaccine manufacturer in the world,
Chiron remains dedicated to the legacies of von Behring and Sclavo
to prevent disease and develop new vaccines to improve human health
globally. For more information about Chiron, visit the company's
website at http://www.chiron.com/. This news release contains
forward-looking statements, including statements regarding sales
growth, product development initiatives, new product indications,
new product marketing, acquisitions, and in- and out-licensing
activities that involve risks and uncertainties and are subject to
change. A full discussion of the company's operations and financial
condition, including factors that may affect its business and
future prospects, is contained in documents the company has filed
with the SEC, including the form 10-Q for the quarter ending March
31, 2004, and the form 10-K for the year ended December 31, 2003,
and will be contained in all subsequent periodic filings made with
the SEC. These documents identify important factors that could
cause the company's actual performance to differ from current
expectations, including the outcome of clinical trials, regulatory
review and approvals, manufacturing capabilities, intellectual
property protections and defenses, stock-price and interest-rate
volatility, and marketing effectiveness. In particular, there can
be no assurance that Chiron will increase sales of existing
products, successfully develop and receive approval to market new
products, or achieve market acceptance for such new products. There
can be no assurance that Chiron's out-licensing activities will
generate significant revenue, nor that its in-licensing activities
will fully protect it from claims of infringement by third parties.
In addition, the company may engage in business opportunities, the
successful completion of which are subject to certain risks,
including shareholder and regulatory approvals and the integration
of operations. Consistent with SEC Regulation FD, we do not
undertake an obligation to update the forward-looking information
we are giving today. DATASOURCE: Chiron Corporation CONTACT: Chiron
Corporate Communications & Investor Relations, media,
+1-510-923-6500, or investors, +1-510-923-2300 Web site:
http://www.chiron.com/
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