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Galena Biopharma Inc Announces Initial Results From The Folate Binding Protein Vaccine Phase 1 Trial


Monday, 11 Nov 2013 07:35am EST 

Galena Biopharma Inc announced the results of the Phase 1 portion of the trial for the Folate Binding Protein (FBP) vaccine. FBP 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 Phase 1 component was a 3x3, dose-escalation, safety trial enrolling disease-free endometrial and ovarian cancer, HLA-A2 positive patients into the vaccine group, while HLA-A2 negative patients were being followed prospectively as an untreated control group. Six monthly intradermal inoculations of either 100mcg, 500mcg, or 1000mcg of peptide vaccine + 250 mcg GM-CSF immunoadjuvant were administered during the primary vaccine series. Immunologic responses were assessed by both local reaction after each inoculation and by delayed-type hypersensitivity (DTH) reaction measured pre-vaccination and after the primary vaccine series. Recurrences are determined clinically. 31 patients were enrolled in the Phase 1 trial: 15 in the vaccine group and 16 in the active control group. There were no significant differences in age, grade, stage, or nodal status between groups. Overall, the vaccine was well tolerated with the majority of local and systemic toxicities Grade 1. 

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