Galena Biopharma Says Doses First Patient In GALE-401 Phase 2 Clinical Trial

(RTTNews) - Galena Biopharma, Inc. (GALE) Tuesday said the first patient has been dosed in its GALE-401 or Phase 2 clinical trial. The Phase 2 trial is an open-label, single-arm, multicenter study of GALE-401 in 20 patients with MPN-related thrombocytosis. The study aims to confirm the platelet-lowering activity of GALE-401 in patients with MPNs, to assess safety and tolerability, and to measure blood levels of the drug. The primary efficacy endpoint will be the proportion of subjects who achieve a complete or partial platelet response for at least four weeks during the first six months of treatment.

The company said it would pursue approval via the 505(b)(2) regulatory pathway.