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MedImmune Advances Asthma Program with Start of a Phase 2 Trial in Europe and Australia and First U.S.-Based Clinical Trial for Antibody Targeting IL-13
Date:4/15/2008

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
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