Galena Enrolls First Ovarian Cancer Patient

Galena Biopharma has enrolled the first patient in the Phase II 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 II trial, which will be 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 six-month intervals. The primary objective of the trial is to measure immune response, with secondary outcomes of recurrence.

Initial results from the Phase I trial determined the optimal dose and showed that GALE-301 was well tolerated and evoked a FBP specific immunological response. After a median follow-up of six months from completion of the vaccine series, there were 2 recurrences (13.3%; n=15) in the vaccine group vs. 4 recurrences (25%, n=16) in the control group, although the trial was not powered for any efficacy measurements.