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news.KaloBios Pharmaceuticals has initiated Phase I/II clinical trial of KB001, a humaneered, high-affinity antibody fragment that KaloBios is developing for the treatment of Pseudomonas aeruginosa infections.
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The randomized, double-blinded, placebo-controlled trial, which is being conducted at over 10 sites across France, will enroll up to 36 patients in the intensive care setting who are receiving ventilator therapy and who have Pseudomonas infections. They will receive either one of two dose levels of KB001 or placebo.
Endpoints for the study include safety, reduction of Pseudomonas bacteria, and progression of pneumonia endpoints. KaloBios’s Humaneering technology is a proprietary method for converting non-human antibodies into engineered human antibodies.
Tillman Pearce, chief medical officer of KaloBios, said: “This is our first study of KB001 for Pseudomonas infections in the hospital acute care setting, which complements our ongoing Phase I/II trial for this product in cystic fibrosis.”