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Breaking News, Trials & Filings

KaloBios Gets Orphan Status for CF Treatment

mAb fragment currently in Phase II

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

KaloBios Pharmaceuticals, Inc. has received Orphan Drug Designation from the FDA for KB001-A, an anti-PcrV monoclonal antibody fragment, for the treatment of cystic fibrosis (CF) patients with Pseudomonas aeruginosa (Pa).

KaloBios is currently enrolling patients in a Phase II multiple-dose, randomized, double-blind, placebo-controlled clinical trial with KB001-A in CF patients chronically infected with Pa. This 180-patient study is intended to evaluate the efficacy and safety of repeat doses of KB001-A. The primary endpoint is time-to-need for antibiotics.

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