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Galena Biopharma Expands NeuVax(TM) Intellectual Property With European Allowance

PORTLAND, Ore., Aug. 21, 2013 (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 European Patent Office notified the Company of an intention to grant a Pharmaceutical Use Patent for NeuVax™ (nelipepimut-S). The patent covers the use of NeuVax as a vaccine for the prevention of relapse in breast cancer patients with an immunochemistry (IHC) rating of 1+ or 2+ for HER2 /neu protein expression and a fluorescence in situ hybridization (FISH) rating of less than 2.0 for HER2 /neu gene expression. The patent protection is afforded in all of the European countries and will expire in April 2028.

"This patent expands our intellectual property protection for NeuVax in Europe, and further validates our novel, cancer immunotherapy approach to preventing the recurrence of breast cancer in women who otherwise have no treatment options," said Mark J. Ahn, Ph.D., President and CEO. "NeuVax is the only drug currently in Phase 3 development for patients with early-stage, node-positive breast cancer with low-to-intermediate HER2 expression status."

About NeuVax™ (nelipepimut-S)

NeuVax™ (nelipepimut-S) is the immunodominant nonapeptide derived from the extracellular domain of the HER2 protein, a well-established target for therapeutic intervention in breast carcinoma. The nelipepimut sequence stimulates specific CD8+ cytotoxic T lymphocytes (CTLs) following binding to HLA-A2/A3 molecules on antigen presenting cells (APC). These activated specific CTLs recognize, neutralize and destroy, through cell lysis, HER2 expressing cancer cells, including occult cancer cells and micrometastatic foci. The nelipepimut immune response can also generate CTLs to other immunogenic peptides through inter- and intra-antigenic epitope spreading. Based on a successful Phase 2 trial, which achieved its primary endpoint of disease-free survival (DFS), the Food and Drug Administration (FDA) granted NeuVax a Special Protocol Assessment (SPA) for its Phase 3 PRESENT ( Prevention of Recurrence in Early- Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) study. The PRESENT trial is ongoing and additional information on the study can be found at www.neuvax.com . A randomized, multicenter investigator sponsored, 300 patient Phase 2b clinical trial is also enrolling patients to study NeuVax in combination with Herceptin® (trastuzumab; Genentech/Roche).

According to the National Cancer Institute, over 230,000 women in the U.S. are diagnosed with breast cancer annually. Of these women, only about 25% are HER2 positive (IHC 3+). NeuVax targets the approximately 50%-60% of these women who are HER2 low to intermediate (IHC 1+/2+ or FISH < 2.0) and achieve remission with current standard of care, but have no available HER2-targeted adjuvant treatment options to maintain their disease-free status.

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