NeuVax: Phase III started

Galena disclosed in its 4Q11 earnings that in January it began the double-blind, international Phase III PRESENT trial evaluating NeuVax vs. Leukine sargramostim in about 700 patients with operable early-stage, node-positive breast cancer with low to intermediate HER2 expression who are ineligible for treatment with Herceptin trastuzumab . Patients are receiving intradermal injections administered once monthly for 6 months, followed by 5 boosters administered once every 6 months.

Galena (formerly RXi Pharmacueticals Corp.) has an SPA from FDA for the trial. Last year, FDA lifted a July 2009 partial clinical hold on PRESENT after the company resolved issues related to chemistry, manufacturing and controls (CMC) (see BioCentury, Sept. 19, 2011). Also last year, RXi separated its cancer and RNAi assets into two public companies, including Galena, which is developing cancer vaccines (see BioCentury, Oct. 3, 2011). Galena gained NeuVax through RXi's acquisition of Apthera Inc. last year (see BioCentury, April 18, 2011). ...