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December 10, 2013
11:34 EDTKBIOKaloBios announces preliminary Phase 1 results in KB004 trial
KaloBios Pharmaceuticals announced preliminary results of an ongoing multi-center Phase 1 study of KB004, an anti-EphA3 monoclonal antibody, which the company is developing as a treatment for hematologic malignancies. Forty-four patients with refractory disease or who were unfit for chemotherapy have been enrolled in the dose escalation portion of the study. The experimental patient-targeted therapeutic has been well tolerated, with initial evidence of clinical activity. "We are encouraged by the results seen with KB004 to date, which has been well-tolerated at doses up to 190 mg, with mild to moderate transient infusion reactions the most common toxicity," said lead investigator, Jeffrey E. Lancet, M.D. "There are some signs of activity as well, including a patient with relapsed acute myeloid leukemia who had sustained remission for over 1 year." Escalating doses of KB004 were administered as a 1 or 2 hour infusion on days 1, 8, and 15 of a 21 day cycle at incremental doses of 20, 40, 70, 100, 140, 190 and 250 mg and will thereafter increase at 33% increments up to a planned maximum of 700 mg. The primary study objective is to determine a maximum tolerated dose, which has not yet been reached. Secondary objectives included evaluation of pharmacokinetics, immunogenicity and clinical activity. The investigators also evaluated EphA3 expression on tumor, stromal and endothelial cells.
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