MOUNTAIN VIEW, Calif.
March 12, 2013
/PRNewswire/ -- Based on its recent analysis of the breast cancer vaccines market, Frost & Sullivan recognizes Galena Biopharma, Inc. (NASDAQ: GALE) with the 2013 Global Frost & Sullivan Award for New Product Innovation. The company's revolutionary product, NeuVax™, has the potential to address a huge unmet medical need for a breast cancer vaccine and provide significant cost-savings to both patients and governments.
NeuVax (nelipepimut-S or E75), a nonapeptide, derived from the human epidermal growth factor receptor 2 (HER2) oncogene, is co-administered with the immunoadjuvant granulocyte macrophage colony-stimulating factor (GM-CSF) in an intradermal injection. It is the first breast cancer vaccine to reach Phase III clinical trials and could very well emerge as an off-the-shelf cancer immunotherapy treatment to prevent recurrence.
In Phase II studies, NeuVax was shown to prevent or delay breast cancer recurrence in women with early-stage, high-risk (node positive), HER2 low-to-intermediate (immunohistochemical (IHC) 1+/2+ or fluorescent in situ hybridization (FISH) <2.2) disease. NeuVax immunotherapy uses the patient's own immune system to target tumor cells in a highly-specific, less toxic and more-convenient way than conventional cancer therapies.
"Based on Phase II results, the U.S. Food and Drug Administration (FDA) granted NeuVax a Special Protocol Assessment for a Phase III study, for which patient enrollment has already begun," said Frost & Sullivan Senior Research Analyst Aiswariya Chidambaram. "This 700-patient study has a primary endpoint of disease-free survival (DFS) after 139 events or three years—the timeframe within which the disease is likely to relapse in approximately 25 percent of patients."
Multiple clinical trials have proven that NeuVax is safe and effective in stimulating cytotoxic (CD8+) T-cells in a highly specific manner to target HER2 expressing cells. After establishing statistical significance in the prevention of recurrence of breast cancer in 24-month and 36-month periods, the 60-month Phase 1/2 trial demonstrated a 5.6 percent recurrence rate, compared to a 25.9 percent recurrence rate in the control arm.