The Phase 1b is a single-center, randomized, single-blinded, three-arm study in patients with breast (n=35) or ovarian cancer (n=4) diagnosis who have been treated by standard of care and are without evidence of disease. The primary endpoint of the trial is immunologic and designed to determine which of the three PVS strategies maximizes short and long-term specific immunity defined as the number of E39-specific CTLs one and six months, respectively following completion of the PVS."The data presented confirms our assumption that sequencing the delivery of peptides provides varied immune responses and that the delivery can be optimized to potentially provide improved patient outcomes. Most importantly, we achieved a statistically significant increase in LR and DTH when delivering E39 followed by E39' in the PVS (p<0.001). We are currently implementing a booster program and continued analysis of immunologic responses will further elucidate the optimal vaccination series for the prevention of recurrence in breast and ovarian cancer," commented Doreen O. Jackson, M.D., post-doctoral fellow with the Cancer Vaccine Development Program and the San Antonio Military Medical Center, and the poster presenter. HLA-A2-positive breast or ovarian cancer patients were enrolled after completion of standard of care. The PVS includes six inoculations, one every 3-4 weeks containing 250mcg GM-CSF plus 500mcg peptide in the first five patients per arm and 250mcg GM-CSF + 1000mcg of peptide in the second five patients. Thirty-nine patients were randomized into three arms with 30 patients completing the PVS:
- E39 (GALE-301) x 6 inoculations (n=12)
- E39 (GALE-301) x 3 inoculations followed by E39' (GALE-302) x 3 inoculations (n=14)
- E39' (GALE-302) x 3 inoculations followed by E39 (GALE-301) x 3 inoculations (n=13)
About Galena BiopharmaGalena Biopharma, Inc. (NASDAQ:GALE) is a biopharmaceutical company developing and commercializing innovative, targeted oncology therapeutics that address major medical needs across the full spectrum of cancer care. Galena's development portfolio ranges from mid- to late-stage clinical assets, including a robust immunotherapy program led by NeuVax™ (nelipepimut-S) currently in an international, Phase 3 clinical trial. The Company's commercial drugs include Abstral® (fentanyl) Sublingual Tablets and Zuplenz® (ondansetron) Oral Soluble Film. Collectively, Galena's clinical and commercial strategy focuses on identifying and advancing therapeutic opportunities to improve cancer care, from direct treatment of the disease to the reduction of its debilitating side-effects. For more information, visit www.galenabiopharma.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about the progress of the commercialization of our commercial products and development of Galena's product candidates, including GALE-301 and GALE-302, patient enrollment in our clinical trials, as well as other statements related to the progress and timing of our development activities, present or future licensing, collaborative or financing arrangements or that otherwise relate to future periods . These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those identified under "Risk Factors" in Galena's Annual Report on Form 10-K for the year ended December 31, 2014 and most recent Quarterly Reports on Form 10-Q filed with the SEC. Actual results may differ materially from those contemplated by these forward-looking statements. Galena does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this press release. Abstral and NeuVax are trademarks of Galena Biopharma, Inc. All other trademarks are the property of their respective owners.
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