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Frost & Sullivan Applauds Galena Biopharma  (GALE) for Its Breakthrough Breast Cancer Vaccine, NeuVax™

3/12/2013 10:17:07 AM

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 yearsthe 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.

NeuVax has also delivered promising results in combination with Herceptin® (trastuzumab; Roche/Genentech) in early-stage HER2 1+, 2+ patients. Preclinical studies with trastuzumab suggest that the drug could increase antigen presentation by tumor cells by promoting receptor internalization and subsequent proteosomal degradation of the HER2 protein, resulting in efficient recognition and lysis of HER2-expressing cells. In addition, a Phase IIa study (NeuVax + trastuzumab) showed improved efficacy of the combination therapy at the end of 24 months, with no added cardiotoxicity.

Encouraged by these positive results, Galena Biopharma will commence a 300-patient Phase IIb study in early-stage HER2 1+, 2+ patients, who were previously on adjuvant chemotherapy and radiation therapy. This will enable the company to compare NeuVax with trastuzumab combination versus trastuzumab monotherapy.

"NeuVax is capable of continuously activating the immune system and maintaining therapeutic levels of killer T-cells with a convenient intradermal-dosing schedule, unlike the existing monoclonal antibody therapy, which requires frequent, ongoing and intravenous infusion," noted Chidambaram. "This not only provides significant cost-saving benefits to the patient, but also improves compliance."

Each year, Frost & Sullivan presents this award to the company that has developed an innovative element in a product by leveraging leading-edge technologies. The award recognizes the value-added features/benefits of the product and the increased ROI it offers customers, which, in turn, increases customer acquisition and overall market penetration potential.

Frost & Sullivan Best Practices Awards recognize companies in a variety of regional and global markets for demonstrating outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service, and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analysis, and extensive secondary research in order to identify best practices in the industry.

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.

About Galena Biopharma, Inc.

Galena Biopharma, Inc. (NASDAQ: GALE) is a Portland, Oregon-based biopharmaceutical company that develops innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care. For more information please visit us at

About Frost & Sullivan

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