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January 7, 2013
08:12 EDTXOMAXOMA announces encouraging interim results from Gevokizumab Phase 2 study
XOMA announced preliminary top-line data from an interim analysis of its Phase 2 proof-of-concept, or POC, study to evaluate the safety and efficacy of gevokizumab, a potent modulator of interleukin-1 beta, for the treatment of the inflammatory facial lesions seen in patients with moderate to severe acne vulgaris. The Phase 2 POC study is a double-blind randomized comparison of gevokizumab 0.2mg/kg and 0.6mg/kg versus placebo given subcutaneously once per month for three consecutive months. Investigators have enrolled a total of approximately 125 patients to date, and the interim results are based on up to 92 patients with available data. In line with FDA guidance, inflammatory lesion counts, the primary endpoint in this trial, and overall acne severity as assessed by responder analysis of the Investigator Global Assessment, defined as at least a two-point improvement on a five-point scale, were measured at different time points up to Day 84.
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May 11, 2015
06:50 EDTXOMAXOMA management to meet with Jefferies
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