GAITHERSBURG, Md., April 15 /PRNewswire/ -- MedImmune today announced that
it has advanced its efforts to develop CAT-354, a potential treatment for
patients with asthma, with the start of two new trials with a monoclonal
antibody (MAb) targeting interleukin-13 (IL-13). One of the studies is a Phase
2 clinical trial in Europe and Australia designed to assess the potential of
the anti-IL-13 MAb in patients with uncontrolled asthma despite optimal
treatment. The company has also begun dosing patients in the first U.S.-based
clinical trial of the antibody, a Phase 1 study to assess pharmacokinetics in
healthy adult patients.
"We are pleased to advance CAT-354 into its first Phase 2 clinical trial
to assess the antibody's potential to help patients with asthma gain control
of their often debilitating symptoms," said Barbara White, M.D., vice
president, clinical development, inflammatory disease. "Initiating our
clinical work in the U.S. is also an important step in bolstering the depth of
data we are gathering for this potential asthma treatment."
The Phase 2 clinical trial is designed to assess the effects of CAT-354 on
airway hyperresponsiveness in patients with uncontrolled asthma. This
randomized, double-blind, placebo-controlled study has started in Europe and
Australia.
The first Phase 1 clinical trial of CAT-354 in the U.S. is designed to
compare the pharmacokinetics of the antibody when administered via
subcutaneous injection versus intravenous infusion in healthy patients. This
randomized, open-label, study in healthy male patients marks the first
clinical trial to assess the subcutaneous administration of CAT-354, as
previous studies have used intravenous infusion administration.
CAT-354, a recombinant human monoclonal antibody of the G4 subclass,
targets IL-13. Early pre-clinical data have shown the potential of the
antibody to treat varying degrees of asthma. The effects of CAT-354 have been
investigated in in vitro and in vivo systems and Phase 1 data in mild to
moderate asthmatic volunteers demonstrated the safety and tolerability of the
monoclonal antibody, thus supporting its continued development.
About Interleukin-13 (IL-13)
Preclinical data has demonstrated that IL-13 plays an important role in
asthma. It is one of at least 29 naturally occurring interleukins in the human
body. Overexpression of IL-13 in animal models has been shown to result in
many of the features associated with human asthma. IL-13 is believed to be a
relevant target for treating asthma, considering its potential role in airway
obstruction and in chronic airways remodeling, as seen in animal models.
Clinical Development in Asthma
MedImmune has multiple approaches in development targeting asthma.
Currently, in human testing the company has antibodies targeting IL-9 (MEDI
528) and IL-13 (CAT-354), each in Phase 2 development, and an anti-IL-5
receptor (MEDI 563), which is in Phase 1 development. In addition, the
company has a number of antibodies that are anticipated to be designated as
drug candidates.
About Asthma
Asthma is a chronic disease of the airways that may cause wheezing,
breathlessness, chest tightness and coughing. According to the U.S. Centers
for Disease Control and Prevention (CDC), more than 30 million Americans
reported having a history of asthma in 2003, including nine million children.
About 20 million said they currently had asthma. In 2000, the CDC reported
that there were more than 10 million asthma-related outpatient visits to
private physician offices and hospital clinics. The National Institutes of
Health (NIH) have estimated asthma-related healthcare costs in the U.S. at $14
billion annually.
About MedImmune
MedImmune strives to provide better medicines to patients, new medical
options for physicians and rewarding careers to employees. Dedicated to
advancing science and medicine to help people live better lives, the company
is focused on cardiovascular/gastrointestinal disease, neuroscience, oncology,
infection, respiratory disease and inflammation. With approximately 3,000
employees worldwide and headquarters in Maryland, MedImmune is wholly owned by
AstraZeneca plc (LSE: AZN.L, NYSE: AZN). For more information, visit
MedImmune's website at http://www.medimmune.com.
SOURCE MedImmune
-0- 04/15/2008
/CONTACT: Media: Jamie Lacey, +1-301-398-4035, or Investors: Peter Vozzo,
+1-301-398-4358, both of MedImmune/
/Web site: http://www.medimmune.com /
(AZN)
CO: MedImmune; AstraZeneca plc
ST: Maryland, Australia
IN: BIO MTC HEA
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