GALE - news- Galena Biopharma enrolls first patient in GALE-301 (Folate Binding Protein (FBP)) cancer immunotherapy Phase 2 clinical trial in ovarian cancer (GALE) :
•Co announced the first patient has been enrolled in the Phase 2 trial for GALE-301 (Folate Binding Protein (FBP) vaccine). GALE-301 is a folate receptor alpha-derived, peptide-based cancer immunotherapy administered to HLA-A2 positive patients in combination with granulocyte macrophage-colony stimulating factor (GM-CSF) as an adjuvant treatment to prevent recurrences in high-risk, endometrial and ovarian cancer patients rendered disease-free after completing standard of care therapy.
•The optimized dose, along with the implementation of a booster regimen, will be used in the Phase 2 trial. The Phase 2 trial is an open-label trial with two arms consisting of HLA-A2 positive patients treated with the FBP peptide plus adjuvant versus active control. After an initial induction series of six vaccinations given once per month, patients will be boosted twice at 6-month intervals. The primary objective of the trial is to measure immune response, with secondary outcomes of recurrence.
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