Baxter International
Inc. (NYSE: BAX) recently announced promising initial study data for its
candidate, Vero cell-based seasonal influenza vaccine, now undergoing a
Phase I/II clinical trial in Europe. The preliminary data indicate that the
vaccine induced strong antibody responses and good tolerability in all
study populations.
The findings were presented by Hartmut J. Ehrlich, M.D., vice president
of Global Research and Development for Baxter's BioScience business at a
June gathering of laboratory and clinical scientists and public health
professionals at the Options for the Control of Influenza VI Conference in
Toronto, Canada. The active, controlled, multi-center Phase I/II trial of
the seasonal influenza vaccine was designed to evaluate safety and
immunogenicity of the candidate vaccine in approximately 940 subjects
divided between the ages of 18-49 and 50 years of age and older.
The Phase I/II study data indicate that Baxter's seasonal candidate
vaccine, which was developed using a split virus process, was effective in
inducing protective levels of antibodies for all three seasonal virus
strains in both age levels. Split viruses are most frequently used for
seasonal influenza vaccines. Baxter's investigational pandemic H5N1
influenza vaccine, currently in Phase III trials in Europe, was developed
using a whole-virus process.
In the 18-49 subject population, 99.6 percent achieved protective
antibody levels for virus strains H1N1 and H3N2, and 92.9 percent for
strain B. In the 50 years of age and older population, 96.6 percent
achieved protective levels for virus strain H1N1, 100 percent for H3N2 and
73.3 percent for strain B.
Work on this vaccine is being completed as part of a U.S. Department of
Health and Human Services (DHHS) Office of Public Health and Emergency
Preparedness contract awarded to DynPort Vaccine Company LLC (DVC), a
Computer Sciences Corporation (NYSE: CSC) company, and Baxter in May 2006
to develop seasonal and pandemic influenza vaccines. Under this contract,
DVC is managing the project and clinical trials. Baxter is manufacturing
the vaccines and will serve as the U.S. Food and Drug Administration (FDA)
license-holder.
"I am very encouraged by the preliminary results of this Phase I/II
clinical trial, which suggest that this cell culture-derived vaccine may
provide protection against seasonal influenza with minimal side effects,"
said Frank von Sonnenburg, M.D., head of the Section of International
Medicine and Public Health in the Department of Infectious Diseases and
Tropical Medicine at the University of Munich.
Baxter's seasonal influenza candidate vaccine is manufactured using the
company's proprietary Vero cell technology. The use of Vero cell culture,
rather than conventional egg-based technology, offers several advantages.
Baxter's Vero cell culture process can be initiated more rapidly due to its
use of a "native" virus that does not need to be modified to allow growth
in eggs, thus accelerating vaccine availability. Vaccines produced using
the process can be released within approximately 12 weeks, significantly
earlier than with traditional egg-based systems. In addition, all influenza
strains with pandemic potential tested for growth in Vero cells have
produced consistent high yields, providing the flexibility to quickly
respond to emerging variant pandemic virus strains.
"Combined with the recent encouraging results from our pandemic H5N1
clinical trial, these data provide further evidence suggesting the Vero
cell platform can reliably deliver safe and effective influenza vaccines in
pandemic or interpandemic situations," said Dr. Noel Barrett, vice
president of Global Research and Development for Baxter's Vaccines
Business. "This early indication of an acceptable safety profile and
immunity against key seasonal influenza viral strains is critically
important as we plan the Phase III clinical trial program to provide a
solid measure of the vaccine's potential to protect a large number of
people during the influenza season."
Phase I/II Data
Preliminary data from the Phase I/II clinical trial presented at the
Toronto meeting showed the candidate vaccine's tolerability profile to be
similar to currently marketed, egg-based seasonal flu vaccines. The vaccine
also generated substantial levels of cross immunity against three seasonal
strains. The most common side effects observed for the trial vaccine were
injection site reactions, headaches and malaise.
In addition, the analysis demonstrated that the vaccine met European
Committee for Medicinal Products for Human Use (CHMP) criterion for
influenza vaccine licensure with all three strains, in both age groups
tested. The criterion requires that adults achieve specific levels of
immunity or "seroprotection" following vaccination.
ACKNOWLEDGEMENTS:
1. This project has been funded in whole or in part with Federal (United
States Government) funds from the Office of Public Health Emergency
Preparedness, Office of Research and Development Coordination, under
contract number HHS0100200600013C.
2. Pursuant to Section 507 of P.L. 104-208 and Section 508 of P.L. 105-78;
100% of the total of this project's costs are financed with Federal
(United States Government) money.
3. The content of this publication does not necessarily reflect the views
or policies of the United States Department of Health and Human
Services, nor does mention of trade names, commercial products, or
organizations imply endorsement by the U.S. Government.
About CSC
Computer Sciences Corporation is a leading global information
technology (IT) services company. CSC's mission is to provide customers in
industry and government with solutions crafted to meet their specific
challenges and enable them to profit from the advanced use of technology.
With approximately 87,000 employees, CSC provides innovative solutions
for customers around the world by applying leading technologies and CSC's
own advanced capabilities. These include systems design and integration; IT
and business process outsourcing; applications software development; Web
and application hosting; and management consulting. Headquartered in El
Segundo, Calif., CSC reported revenue of $14.9 billion for the 12 months
ended March 30, 2007. For more information, visit the company's Web site at
csc.
About Baxter
Baxter International Inc., through its subsidiaries, assists healthcare
professionals and their patients with the treatment of complex medical
conditions, including hemophilia, immune disorders, cancer, infectious
diseases, kidney disease, trauma and other conditions. The company applies
its expertise in medical devices, pharmaceuticals and biotechnology to make
a meaningful difference in patients' lives.
The safety and efficacy of this product has not been established. This
product is currently under clinical investigation and has not been licensed
by the FDA.
This release includes forward-looking statements concerning the
company's vaccine products, including with respect to clinical trials,
licensures, and the advantages of the vaccine products. The statements are
based on assumptions about many important factors, including the following,
which could cause actual results to differ materially from those in the
forward-looking statements: satisfaction of regulatory and other
requirements for timely commencement of additional clinical trials;
additional clinical results demonstrating the safety and efficacy of the
products; market acceptance of vaccines developed with Vero cell technology
relative to egg- based or other alternatives; continued public commitment
to addressing avian flu and other pandemic threats including additional
experience producing such vaccines at a large scale; and other risks
identified in the company's most recent filing on Form 10-Q and other SEC
filings, all of which are available on the company's web site. The company
does not undertake to update its forward-looking statements.
Baxter International
baxter
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