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Galena Biopharma Enrolls First Patient In GALE-301 (Folate Binding Protein (FBP)) Cancer Immunotherapy Phase 2 Clinical Trial In Ovarian Cancer

PORTLAND, Ore., Jan. 7, 2014 (GLOBE NEWSWIRE) -- Galena Biopharma (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today 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. 

"With GALE-301 progressing into its Phase 2 trial, we continue to demonstrate progress of our innovative cancer immunotherapy pipeline," said Mark J. Ahn, Ph.D., President and Chief Executive Officer. "Once recurrent, ovarian and endometrial cancers are two of the deadliest malignancies, therefore preventing metastatic disease is critical. We are encouraged by the promising early results of GALE-301 in addressing this critical unmet medical need."

Initial results from the Phase 1 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.

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