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LAKE OSWEGO, Ore., March 14, 2013 (GLOBE NEWSWIRE) -- Galena Biopharma (Nasdaq:GALE), a biopharmaceutical company developing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, announced that independent research firm, Frost & Sullivan, has recognized Galena Biopharma with the 2013 Global Frost & Sullivan Award for New Product Innovation. The Company accepted the honor at the Frost & Sullivan Award Gala, held March 12, 2013 in San Diego, CA.
"We are honored to receive this prestigious award from Frost & Sullivan," said Mark J. Ahn, Ph.D., President and CEO of Galena Biopharma. "Galena remains dedicated to the development and commercialization of innovative, personalized treatment options for women with breast cancer. We are grateful to the researchers, employees, and especially patients who participate in clinical trials, for their invaluable support to advance NeuVax."
About NeuVax™ (nelipepimut-S or E75)
NeuVax (nelipepimut-S) is the immmunodominant 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 (CTL) 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 Phase 3 trial is ongoing and additional information on the study can be found at the recently updated website
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 negative (IHC 1+/2+ or FISH < 2.2) and achieve remission with current standard of care, but have no available HER2-targeted adjuvant treatment options to maintain their disease-free status.