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news.KaloBios Pharmaceuticals has started a Phase I/II clinical trial of KB001, a humaneered, high-affinity antibody fragment that KaloBios is developing for the treatment of P aeruginosa infections. The trial is being conducted in conjunction with the Cystic Fibrosis Foundation and its affiliated organizations.
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The blinded, placebo-controlled trial, which is being conducted at over 10 sites across the US, will enroll up to 48 patients with cystic fibrosis who will receive either one of two dose levels of KB001 or placebo. Endpoints for the trial include safety, reduction of P aeruginosa bacteria, and inflammatory markers.
Geoffrey Yarranton, chief scientific officer of KaloBios, said: “KB001 is a very novel approach that targets the principal mechanism by which P aeruginosa becomes pathogenic. We have demonstrated in both laboratory and rodent studies that KB001 is active against drug resistant strains of this bacterium.”