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news.MedImmune has initiated a multi-dose, phase IIa clinical trial with its monoclonal antibody targeting interleukin-9 in adults with mild, persistent asthma.
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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 IIa study currently underway with the MAb, known as MEDI-528. Genaera and MedImmune entered into a collaborative licensing agreement for this program in 2001.
Two previous phase I 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. MedImmune is also conducting an ongoing phase IIa 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.
Plans to initiate a third phase IIa 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 are underway.