Galena Biopharma (GALE) completes enrollment of the full 45-patient cohort for the Phase 2a clinical trial for GALE-301 (Folate Binding Protein (FBP) peptide immunotherapy). The two arms of the trial consist of HLA-A2-positive patients treated with the FBP peptide plus granulocyte macrophage-colony stimulating factor (GM-CSF) and an observational control group of HLA-A2-negative patients. After an initial induction series of six vaccinations given once per month, patients will receive booster inoculations at two subsequent six-month intervals. The primary objectives are to measure the immune response, time to recurrence and overall survival between treatment arms.
GALE-301 plus GM-CSF is an adjuvant treatment to prevent recurrences in high-risk ovarian and endometrial cancer patients rendered disease-free after completing standard-of-care therapy.