Galena Biopharma Reports Clinical Biomarker Data Demonstrating the Role of NeuVax(TM) in Preventing Breast Cancer Recurrence

LAKE OSWEGO, Ore., Oct. 26, 2012 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc. GALE, a biotechnology company focused on developing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, presented data from the Phase 1/2 clinical trial of NeuVax™ (nelipepimut-S or E75) at the 27^th Annual Meeting of the Society for Immunotherapy of Cancer. The event is being held October 26-28, 2012 at the Bethesda North Marriott Hotel & Conference Center in North Bethesda, Maryland.

The poster presentation entitled: "Trends in Circulating Tumor Cells (CTCs) in Multiple Adjuvant Trials of HER2-Directed Peptide Vaccines (PVs)" measured CTCs from blood samples from NeuVax (nelipepimut-S or E75) patients using the CellSearch^® system (Veridex). CTCs are cells that have detached from the primary breast tumor and circulate in the bloodstream, and may then cause the growth of additional tumors (metastases) in different tissues. These recurrences may occur soon after the original cancer or many years after the initial treatment. Increased presence of CTCs predicts the likelihood of a recurrence of the cancer resulting in poor disease-free survival (DFS) and overall survival (OS), suggesting a dormancy of isolated micrometastases.

These results showed a total of 26 patients receiving NeuVax had at least two CTC measurements made during the vaccine treatment. In 16/26 NeuVax treated patients, the CTCs decreased during the time of treatment, corresponding with an increase in the patients' E75-specific CD8+ cytotoxic T-lymphocytes (killer T-cells) and an increase in their delayed type hypersensitivity (DTH) reactions.  DTH is the measurable signal on the skin that the patient is immunologically responding to treatment. None of these patients had a recurrence of their cancer during the five year follow-up period.

Data presented indicate that vaccine treated patients were more likely to show a decrease in CTCs than control patients. Furthermore, the use of NeuVax boosters appears to provide long-term benefit from the return of CTC. As a result, investigators concluded that these results lend credence to the notion that breast cancer is a chronic disease and that monitoring CTC trends may be clinically useful in the adjuvant setting as a surrogate for response to vaccine treatment.

"Even with the major advances in earlier diagnoses and better treatment options,approximately 25% of resectable node-positive breast cancer patients will still relapse within three years, despite having no evidence of disease following surgery and chemotherapy/radiation treatment," stated Mark J. Ahn, Ph.D., Galena's President and Chief Executive Officer.  "The data presented today shows that treatment with NeuVax reduces CTCs and therefore may prevent growth of future micrometastasis, lending support to the idea of using the woman's immune system to prevent relapse of her breast cancer."

Final NeuVax Phase 1/2 results will be reported at the San Antonio Breast Cancer Symposia in December 2012.

About NeuVax (nelipepimut-S)

NeuVax™ (nelipepimut-S) is the immunodominant nine amino acid 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 www.neuvax.com.

According to the National Cancer Institute, over 230,000 women in the U.S. are diagnosed with breast cancer annually. Of these women, about 75% test positive for HER2 (IHC 1+, 2+ or 3+). NeuVax targets approximately 50-60% of HER2-positive patients (IHC 1+/2+ or FISH <2.2) who 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

Galena Biopharma, Inc. 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 www.galenabiopharma.com.     

The Galena Biopharma, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=10647

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 possible benefits of Galena's new product candidates. These forward-looking statements are subject to a number of risks and uncertainties, including those identified under "Risk Factors" in Galena's most recently filed Annual Report on Form 10-K and Quarterly Report on Form 10-Q and in other filings Galena periodically makes 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 presentation.