Method for characterizing the efficacy of an agent targeting...

Details Method for characterizing the efficacy of an agent targeting... Method for characterizing the efficacy of an agent targeting...

2006-01-27

2009-02-03

Weber, Jon P (Department: 1657)

Drug, bio-affecting and body treating compositions

In vivo diagnosis or in vivo testing

Testing efficacy or toxicity of a compound or composition

Reexamination Certificate

active

07485284

ABSTRACT:
Generally, the method for characterizing the efficacy of an agent targeting a primary cystic fibrosis defect comprises measuring a change in the status of lung infection in a sample population of subjects administered the agent in comparison to a control sample population of subjects; wherein the subjects in the sample population and the control sample population have the primary cystic fibrosis defect and are uninfected before the agent is administered; wherein a beneficial change in the presence of lung infection in the sample population in comparison to the control sample population is indicative of a treatment effect; and wherein the agent lacks intrinsic antibiotic activity.

REFERENCES:
patent: WO 98/31706 (1998-07-01), None
patent: WO 00/29588 (2000-05-01), None
patent: WO 01/90129 (2001-11-01), None
Takai et al., “New Therapeutic Key for Cystic Fibrosis: a Role for Lipoxins”Nature Immunology 5(4) :357-358, Apr. 2004.
Lang et al., “Prophylaxis and Therapy ofPseudomonas aeruginosaInfection in Cystic Fibrosis and Immunocompromised Patients”Vaccine 22:S44-S48, 2004.
Karp et al., “Defective Lipoxin-Mediated Anti-Inflammatory Activity in the Cystic Fibrosis Airway”Nature Immunology 5(4) :388-392, Apr. 2004.

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