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KaloBios Pharmaceuticals receives approval from US FDA for KB003
31 July 2015 - KaloBios Pharmaceuticals, a biopharmaceutical company dedicated to improving the lives of patients with innovative therapies, has received approval from the US Food and Drug Administration for its investigational new drug application for KB003, an anti-GM-CSF monoclonal antibody, it was reported yesterday.The product is intended to treat patients with chronic myelomonocytic leukaemia. The IND acceptance allows the company to commence an open-label Phase I trial, aimed at evaluating the safety, pharmacokinetics and clinical activity of KB003 in previously treated CMML patients.The trial will include an accelerated dose escalation component starting at 200mg and escalating up to 600mg, followed by a group expansion of up to 13 additional patients to explore clinical activity at the selected dose level.
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