Chiron (NASDAQ:CHIR)
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Chiron Corporation (NASDAQ:CHIR) today announced
preliminary promising data from a clinical study of its
investigational vaccine against an H9N2 avian influenza strain that
has infected a small number of people and may have the potential to
cause a human pandemic. The trial was supported by the National
Institute of Allergy and Infectious Diseases (NIAID), part of the U.S.
National Institutes of Health (NIH).
The 96-patient study explored the safety and immunogenicity of
four different doses of the investigational vaccine with and without
Chiron's adjuvant MF59. An adjuvant is a substance that is added to a
vaccine to boost the body's immune response to the vaccine's antigen.
All vaccine formulations containing the adjuvant MF59 proved highly
immunogenic, inducing antibody levels believed to confer protection
against the influenza strain. The lowest dose contained 3.75
micrograms of antigen per dose, a quarter of the dose used in seasonal
influenza vaccines. In marked contrast, the unadjuvanted vaccine
induced significantly lower antibody titers and did not reach levels
achieved by the adjuvanted vaccine following any of the antigen doses
tested, which ranged from 3.75 to 30 micrograms.
"This study builds on the clinical data Chiron has already
established with adjuvanted influenza vaccines," said Rino Rappuoli,
Ph.D., chief scientific officer of Chiron and head of research for
Chiron Vaccines. "With more than 20 million doses of MF59-adjuvanted
vaccine distributed outside of the United States for seasonal
vaccination, we have built an impressive safety database. In addition,
our previous clinical studies of a vaccine designed to protect against
H5 avian influenza have demonstrated the potential of our adjuvant to
reduce the required dose of antigen and to cross-protect against a
range of related viral strains.
"This important collaborative research further advances our
understanding of the role innovative adjuvant technology can play in
enhancing the immune response to pandemic vaccines, providing the
potential for dose-sparing to stretch production capacity," continued
Dr. Rappuoli. "Following these successful results, we look forward to
clinical studies of an adjuvanted H5N1 vaccine planned for the near
future."
"Adjuvants could be an important means of improving the immune
response to potential pandemic strains and allow us to stretch
production capacity," added Walter A. Orenstein, M.D., professor of
medicine of pediatrics and associate director of the Emory Vaccine
Center in Atlanta, Georgia.
"Public-private partnerships are an essential part of our
preparations for a potential pandemic, and this study clearly
demonstrates their value," said Dan Soland, president of Chiron
Vaccines. "NIAID has taken the lead in sponsoring clinical trials to
determine the optimal characteristics of an effective and safe
pandemic vaccine. This trial builds on that knowledge, providing
valuable data on the importance of using adjuvants, which may be
critical for extending the vaccine supply to reach as many people as
possible."
About Pandemic Influenza
Pandemic influenza occurs when a new influenza virus emerges that
is easily transmitted among humans and causes serious illness. In this
situation, the virus can result in a worldwide outbreak of disease, or
pandemic. Pandemic influenza occurred three times in the last century.
The 1918 pandemic killed at least 40 million people worldwide, with a
mortality rate of approximately 2.5 percent in the United States.
Avian influenza, or "bird flu," does not normally infect humans,
but there have been several examples in recent years of transmission
to people, leading to fears of a strain with the potential to result
in a pandemic. The current outbreak of H5N1 avian influenza in
Southeast Asia has resulted in more than 100 human cases, in Cambodia,
Indonesia, Thailand and Vietnam, with a mortality rate of
approximately 50 percent. Despite the death or destruction of an
estimated 150 million birds, the virus is now considered endemic in a
number of regions in Southeast Asia.
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About Chiron
Chiron delivers innovative and valuable products to protect human
health by advancing pioneering science across the landscape of
biotechnology. The company works to deliver on the limitless promise
of science and make a positive difference in people's lives. For more
information about Chiron, please visit www.chiron.com.
This news release contains forward-looking statements, including
statements regarding development of pandemic influenza vaccines and
adjuvants, regulatory approvals, improvements to manufacturing
facilities, product development initiatives, and product marketing,
which involve risks and uncertainties and are subject to change. A
discussion of the company's operations and financial condition,
including factors that may affect its business and future prospects
that could cause actual results and developments to differ materially
from those expressed or implied by these forward-looking statements,
is contained in documents the company has filed with the SEC,
including the Form 10-K for the year ended December 31, 2004, and the
Form 10-Q for the quarter ended June 30, 2005, 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, among
others, litigation and investigations relating to influenza vaccines,
the outcome of clinical trials, regulatory review and approvals,
manufacturing capabilities, intellectual property protections and
defenses, litigation, stock-price and interest-rate volatility,
marketing effectiveness, and the severity of the 2005-2006 influenza
season. In particular, there can be no assurance that additional
issues with respect to influenza vaccines or Chiron's manufacturing
generally will not arise in the future, or that Chiron will be able to
increase sales of existing products, successfully develop and receive
approval to market new products (including pandemic influenza
vaccines), or achieve market acceptance for such new products. The
company may face additional competition in the influenza market in the
future and challenges in distribution arrangements as a result of
vaccine developments. In addition, the company may engage in business
opportunities, the successful completion of which is subject to
certain risks, including approval by Novartis AG, regulatory approvals
and the integration of operations.
Chiron does not undertake an obligation to update the
forward-looking information the company is giving today.