Genaera's Trial Of Antibody Targeting Interleukin-9 In Asthma Patients

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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 IL-9 may provide clinical benefit for patients with asthma.

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"We continue to be encouraged by the ongoing progress MedImmune is making in the clinical development of MEDI-528," said Jack Armstrong, President and Chief Executive Officer of Genaera. "The initiation of the exercise-induced bronchoconstriction trial represents another important step in the development of the anti-IL-9 antibody for mild to moderate asthma. We are also pleased by the promising results seen in early trials of this exciting potential respiratory therapy. MEDI-528 is at the forefront of biologics research in the asthma space."

About Interleukin-9

IL-9 has been associated with symptoms of asthma. It is one of at least 29 naturally occurring interleukins in the human body. Overexpression of IL-9 in animal models has been shown to result in many features of asthma, including increased airway inflammation and hyperreactivity. Blocking the actions of IL- 9 has been shown to reduce the increased airway inflammation and airway hyperresponsiveness seen in animal models of asthma. MedImmune is conducting research to evaluate the potential to use MAbs targeting IL-9 to treat or prevent symptomatic, moderate-to-severe, persistent asthma.

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) estimates asthma-related healthcare costs in the U.S. at $14 billion annually.

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