Galena Biopharma (GALE) Initiates E39 Phase 1/2 in Two Gynecological Cancers

Galena Biopharma, Inc. (Nasdaq: GALE), has initiated its Phase 1/2 study of its Folate Binding Protein (E39) vaccine in two gynecological cancers: ovarian and endometrial adenocarcinomas. The FBP vaccine consists of the E39 peptide combined with the immune adjuvant, granulocyte macrophage-colony stimulating factor (GM-CSF). The Phase 1/2 study will test whether the FBP vaccine is safe and effective at inducing an anti-tumor immune response. Furthermore, the study will determine the optimal dose of the vaccine to produce this immunity most efficiently, and whether immunity to FBP will prevent clinical recurrence in patients with ovarian and aggressive endometrial cancer.

FBP is over-expressed (20-80 fold) in more than 90% of ovarian and aggressive endometrial cancers, as well as 20-50% of breast, lung, colorectal, and renal cell carcinomas. FBP has very limited tissue distribution and expression in non-malignant tissue and has many years of validation as an ideal immunotherapy target.

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