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KaloBios KB001 anti-Pseudomonas antibody study published

KaloBios Pharmaceuticals announced the publication of Phase 1 study results for KB001, a first generation, anti-Pseudomonas aeruginosa, or Pa, type III secretion system, or TTSS, antibody, for use in patients with cystic fibrosis, or CF. Data from this initial single dose clinical study supports the continuation of KaloBios' ongoing Phase 2 study of KB001-A, a second generation, anti-TTSS antibody in CF patients with chronic Pa infections. The Phase 1 study results appear online in the journal Pediatric Pulmonology, authored by Carlos Milla, M.D., of the Center for Excellence in Pulmonary Biology, Stanford University, and other members of the KB001 Study Group. The published study results showed a single intravenous dose of KB001 to have an acceptable safety profile and a trend toward a short-term reduction in markers of inflammation, particularly neutrophil elastase which has long been recognized as the main enzyme responsible for lung damage in CF patients. The investigators concluded that repeat-dosing studies are required to evaluate the durability of the anti-inflammatory effects and how treatment with KB001 might translate into clinical benefit. KaloBios is currently enrolling patients in a Phase 2 multi-dose, randomized, double-blind, placebo-controlled clinical trial with KB001-A in CF patients chronically infected with Pa.