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Genaera Announces MedImmune Initiation of Phase 2a Trial of Antibody Targeting Interleukin-9 in Patients with Asthma
Date:3/18/2008

- Study to Assess MEDI-528 in Stable Asthma and Exercise-Induced

Bronchoconstriction -

PLYMOUTH MEETING, Pa., March 18 /PRNewswire-FirstCall/ -- Genaera Corporation (Nasdaq: GENR) today reported that development partner, MedImmune, has initiated its fourth phase 2a clinical trial of MEDI-528, an anti-IL-9 monoclonal antibody (MAb) targeting interleukin-9 (IL-9), in patients with asthma. This clinical trial is designed to assess the potential of MEDI-528 in patients with stable asthma and exercise-induced bronchoconstriction. Genaera and MedImmune entered into a research collaboration and licensing agreement for this program in 2001.

MedImmune is currently evaluating MEDI-528 in patients with asthma in a series of phase 2 clinical trials. The goal of the current phase 2a trial is to assess the safety and tolerability of multiple fixed escalating doses of MEDI-528 in adult patients with stable asthma and exercise-induced bronchoconstriction. The study will also assess the effect of MEDI-528 on exercise challenge testing, as well as the pharmacokinetics and immunogenicity of the investigational treatment. Enrollment of this randomized, double-blind, placebo-controlled trial will take place at multiple sites throughout the U.S. and Canada.

Genaera also noted that MedImmune announced preliminary safety results from an ongoing phase 2 clinical trial of MEDI-528, supporting continued development of the antibody in the mild-to-moderate asthmatic subjects in that trial. Two phase 1 single-dose, dose-escalation studies were previously conducted to evaluate the safety, tolerability and pharmacokinetics of the anti-IL-9 MAb in healthy volunteers. In addition, preclinical data suggest that blocking I
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