MedImmune Initiates Phase 2a Multi-Dose Study in Patients w...( - Company Further Expands Anti-Inter...),Health

- Company Further Expands Anti-Interleukin-9 Program with Second Phase 2a

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GAITHERSBURG, Md., Aug. 1 /PRNewswire/ -- MedImmune, Inc. today announced that it has initiated a multi-dose, Phase 2a clinical trial with its monoclonal antibody (MAb) targeting interleukin-9 (IL-9) in adults with mild, persistent asthma. The placebo-controlled, dose-escalation study is designed to evaluate the safety and tolerability of multiple doses of the antibody. This trial is the second Phase 2a study currently underway with the MAb, known as MEDI-528.

"We are excited to advance the investigation of this potential treatment for patients with asthma and to further explore the role of IL-9 in the pathology of this disease," said Barbara White, M.D., vice president, clinical development, inflammatory disease. "Recent preclinical study results have provided new insight about IL-9's role in a host of functions associated with the onset of asthma, including allergic inflammation in the airways and allergen-induced airway modeling. These data further support our hypothesis that an antibody blocking IL-9 may represent a new long-term maintenance or controller therapy for symptomatic, persistent asthma."

Two Phase 1 single-dose, dose-escalation studies have been conducted to evaluate the safety, tolerability and pharmacokinetics of the anti-IL-9 MAb in healthy volunteers. The antibody was well tolerated in both studies. The company is also conducting an ongoing Phase 2a study, initiated in late 2006, to evaluate the efficacy of a single intravenous dose of MEDI-528 and its effect on disease mechanisms in adults with atopic asthma. MedImmune plans to initiate a third Phase 2a study to evaluate the ability of MEDI-528 to inhibit the biological activity of IL-9 in the bronchoalveolar lavage fluid of adult patients with atopic asthma.

About IL-9

As mentioned above, IL-9 has been associated with symptoms of asthma. It is
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SOURCE MedImmune, Inc. Copyright©2007 PR Newswire.

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