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Progress In Galena Biopharma's (GALE) Phase 1/2 Study With FBP Cancer Vaccine

Jul. 29, 2013 6:00 PM ETSLS
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Biopharmaceutical company Galena Biopharma, Inc. continues its ongoing Phase 1/2 dosing and safety study with the Folate binding protein (FBP) cancer vaccine.

Twenty patients have been enrolled in the first portion of the 1/2a FBP (E39) clinical trial, which is being initially performed as a 3×3, dose-escalation safety trial enrolling endometrial (EC) and ovarian (OC) cancer patients with tumors expressing any level of FBP. E39 + GM-CSF is being administered in the adjuvant setting with the aim of preventing recurrences in high-risk EC and OC patients who have been rendered disease-free with standard-of-care therapy. HLA-A2+ patients are enrolled into the vaccine group (VG), while HLA-A2- patients are being prospectively followed as the untreated control group (CG). During the primary vaccine series (PVS), six monthly intradermal inoculations (R1-R6) of 100/500/1,000 mcg of E39 + 250 mcg GMCSF (immunoadjuvant) are administered to the VG. After each inoculation, local reactions (LR) are measured as the orthogonal mean (OM). IR in the VG is assessed in vivo by delayed type hypersensitivity (DTH) test, measured as the OM. DTH is measured pre-vaccination (R0) and after the PVS (R6).

The arms of the study are well-balanced without any differences in age, grade, stage III, or node positivity status between the groups. E39 was well-tolerated overall, and the study, to date, has shown an 11.1% recurrence rate with E39 versus a 27.3% recurrence rate in the control group, which is a recurrence reduction of 59.3%.

E39 is an immunogenic peptide derived from FBP/FOLR-alpha and is emerging as a potential target for cancer immunotherapy, due to its high expression in various malignancies and its low expression in normal human cells. Early results from Galena's Phase 1/2a trial indicate the E39 vaccine is well-tolerated and elicits a strong in vivo immunologic response that could provide clinical benefit.

A biopharmaceutical company based in Portland, Ore., Galena Biopharma is engaged in the development of innovative, targeted oncology treatments to address major unmet medical needs in the advancement of cancer care. For more information about Galena Biopharma, visit galenabiopharma.com.

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