Galena Biopharma, Inc.
Nov 4, 2011

Galena Biopharma Presents Positive NeuVax(TM) Clinical Results at the 26th Annual Meeting of the Society for Immunotherapy of Cancer

LAKE OSWEGO, Ore., Nov. 4, 2011 (GLOBE NEWSWIRE) -- Galena Biopharma (Nasdaq:GALE), a biotechnology company focused on developing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, announced that positive data from Phase 2 clinical trials of NeuVax™ was presented today at the 26th Annual Meeting of the Society for the Immunotherapy of Cancer. The event is being held November 4-6, 2011 at the Bethesda North Marriott Hotel & Conference Center in North Bethesda, Maryland. 

The abstract entitled: "Vaccination with the HER2-derived E75 peptide vaccine in breast cancer patients may confer greater benefit to patients with less aggressive disease," was presented by Alan K. Sears, MD et al. The Phase 2 trials evaluated the NeuVax (the HER2-derived E75 peptide) vaccine in breast cancer patients in the adjuvant setting. The results suggested that patients with less aggressive disease traits may derive greater clinical benefit from vaccination and have lower rates of breast cancer recurrence. These included vaccinated patients with node negative disease, lower levels of HER2 expression, lower grade tumors, hormone receptor positivity, or lower Adjuvant! Online scores.  This analysis is part of the continued focus on the targeting of active cancer immunotherapies to patients with a lower bioburden of disease. This strategy is the cornerstone of the development strategy for NeuVax, and represents a potent pathway for the development of the next generation of cancer vaccines.

A total of 187 patients were enrolled in the combined trials (vaccine=108, control=79). Patients enrolled in the trial were node positive or high-risk node negative breast cancer patients with any level of HER2 expression (IHC 1+, 2+, or 3+), and rendered disease-free after standard adjuvant therapies. With 60 months median follow-up, the vaccine group experienced a 10.6% recurrence rate compared to 20.3% in the control group (48% risk reduction, p=0.098). Recurrence rates for vaccine and control patients with different disease features (nodal status, HER2 expression, tumor grade, and hormone receptor status) were also analyzed. 

"The results presented today show additional evidence that NeuVax may provide a meaningful clinical benefit in patients with less aggressive forms of breast cancer, and potentially keep them free of their disease, a clear unmet medical need," said Mark J. Ahn, PhD, President and CEO. "It is important to note that this study included an expanded population from the patients we are targeting for our Phase 3 trial. Even with this larger and more diverse group of patients, NeuVax continued to show almost a 50 percent improvement over the control group."

Phase 2 trials were conducted giving the HER2-derived E75 peptide vaccine to breast cancer patients in the adjuvant setting. E75 (HER2:p369-377) is an immunogenic HLA-A2/A3-restricted peptide from the extracellular domain of the HER2 protein, and was combined with GM-CSF (immunoadjuvant) for the trial.  HLA-A2/A3+ patients were vaccinated with E75+GM-CSF while HLA-A2/A3- patients served as controls. The vaccine was given as 4-6 monthly intradermal inoculations, and the primary endpoint of the trial was disease-free survival. 

About NeuVax (E75)

NeuVax consists of the E75 peptide derived from human epidermal growth factor receptor 2 (HER2) combined with the immune adjuvant granulocyte macrophage colony-stimulating factor (GM-CSF). Treatment with NeuVax stimulates cytotoxic (CD8+) T cells in a highly specific manner to target cells expressing any level of HER2. NeuVax is given as an intradermal injection once a month for six months, followed by a booster injection once every six months. 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 expected to commence in the first half of 2012.

According to the National Cancer Institute, over 200,000 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+). Only 25% of all breast cancer patients, those with HER2 3+ disease, are eligible for Herceptin® (trastuzumab; Roche-Genentech), which had revenues of over $5 billion in 2010. NeuVax targets the remaining 50% of HER2-positive patients (HER2 1+ and 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. (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 www.galenabiopharma.com.

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 the transactions recently announced by Galena and the timing of the proposed partial spin-off of its RXi subsidiary, as well as statements about expectations, plans and prospects of the development of Galena's new product candidates. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including the risks that the anticipated benefits of the announced transactions are not achieved and that the proposed spin-off is delayed or is never completed, as well as the risks, uncertainties and assumptions relating to the development of Galena's new product candidates, 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.

CONTACT: Madeline Hatton

         Toll free: +1 (855) 855-GALE (4253), ext. 109

         info@galenabiopharma.com

         

         or

         

         Remy Bernarda

         IR Sense, LLC

         +1 (503) 400-6995

         remy@irsense.com