Galena Biopharma's NeuVax (E75) Clinical Trial Results Published in Cancer

Galena Biopharma announced that the Phase 1/2 clinical trial results from its lead asset, NeuVax(TM) (E75), were published this month in the journal Cancer, published by the American Cancer Society (article may be found at: http://onlinelibrary.wiley.com/doi/10.1002/cncr.26574/abstract)

PORTLAND, OR, USA | October 20, 2011 | Galena Biopharma (Nasdaq:RXII - News), a biotechnology company focused on developing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today announced that the Phase 1/2 clinical trial results from its lead asset, NeuVax(TM) (E75), were published this month in the journal Cancer, published by the American Cancer Society (article may be found at: http://onlinelibrary.wiley.com/doi/10.1002/cncr.26574/abstract).

The leas author of the peer reviewed journal article was Elizabeth A. Mittendorf, MD at the The University of Texas MD Anderson Cancer Center. The article reported the two year landmark analyses of disease-free survival (DFS) from the NeuVax exploratory phase 1/2 clinical trials previously presented at the American Society of Clinical Oncology Breast Cancer Symposium. The trial vaccinated breast cancer patients with E75, a human leukocyte antigen (HLA) A2/A3 restricted HER-2/neu (HER2) peptide, and granulocyte-macrophage colony-stimulating factor (GM-CSF). The vaccine is given as adjuvant therapy to prevent disease recurrence, and has shown to be safe and effective in stimulating expansion of E75-specific cytotoxic T cells. The publication states that the E75 vaccine has clinical efficacy that is more prominent in certain patients, and a Phase 3 trial enrolling lymph node-positive patients with HER2 low-expressing tumors is warranted.

"We are honored to have the NeuVax trial results published in Cancer, highlighting the extraordinary efforts of our investigators and, most importantly, the patients who participated in the study," said Mark Ahn, Ph.D., President and Chief Executive Officer of Galena Biopharma. "Our planned Phase 3 PRESENT trial, expected to be initiated by the first half of next year, will target the prevention of recurrence in early-stage, node-positive breast cancer patients with low-to-intermediate HER2 expression."

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(R) (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:RXII - News) 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.

SOURCE: Galena Biopharma, Inc.

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