Galena Biopharma, Inc.
Jan 5, 2012

Galena Biopharma Announces Investigational New Drug Approval for Phase 2 Trial for NeuVax(TM) (E75 + GM-CSF) Combined With Herceptin(R) (trastuzumab)

Randomized Phase 2 Clinical Study in 300 Patients for Adjuvant Breast Cancer to Initiate in 1H, 2012

LAKE OSWEGO, Ore., Jan. 5, 2012 (GLOBE NEWSWIRE) -- Galena Biopharma (Nasdaq:GALE), a biotechnology company focused on developing innovative, targeted oncology treatments addressing major unmet medical needs to advance cancer care, today announced that the U.S. Food and Drug Administration has approved the Investigational New Drug (IND) application for the Phase 2 combination trial with NeuVax™ (E75 plus GM-CSF) and Herceptin® (trastuzumab; Genentech/Roche). The trial is being funded by Galena Biopharma and Genentech/Roche through the Henry M. Jackson Foundation. Each company will provide their respective drugs for the 300 patient trial and approximately half of the funding necessary to complete the trial. The trial will be conducted at twenty sites worldwide and is expected to commence in the first half of 2012 under the direction of COL George E. Peoples, M.D., FACS, Director, Cancer Vaccine Development Program; Deputy Director, United States Military Cancer Institute; Professor (adjunct), Surgical Oncology, M.D. Anderson Cancer Center; Professor, Surgery, Uniformed Services University; Chief, Surgical Oncology, Brooke Army Medical Center. 

"IND approval for this combination trial with trastuzumab is another major milestone for Galena's product as we now look to initiate two key trials with NeuVax in 2012," said Mark J. Ahn, Ph.D., President and CEO of Galena Biopharma.  "We hope to expand the results from our pilot Phase 2 trial and offer this additional therapy option for women who are not currently eligible to receive HER2-directed therapy as part of standard of care treatment."

From previously published results, NeuVax has shown a decreased recurrence rate in breast cancer patients with HER2 low-expressing tumors. Furthermore, the combination of trastuzumab and NeuVax has been shown to be synergistic with the potential for even better clinical results. This prospective, randomized trial will enroll 300 breast cancer patients with HER2 low-expressing tumors in order to establish the benefit of the combination versus trastuzumab alone in the adjuvant setting.  

A recent poster presentation at the 34th Annual CTRC-AACR San Antonio Breast Cancer Symposium outlined the design of the trial. The study will be a multi-center, prospective, randomized, single-blinded Phase 2 trial evaluating NeuVax + trastuzumab (vaccine) vs. trastuzumab + GM-CSF (control) alone in the adjuvant setting in breast cancer patients. HLA-A2/A3+ node positive (or node negative if also negative for both ER and PR) breast cancer patients with HER2 1+ or 2+ expressing tumors who are disease-free after completing standard adjuvant therapies will be enrolled and randomized. Patients must have adequate cardiac function for enrollment (LVEF > 50%), and randomization will be further stratified based on HER2 status (1+ or 2+) and nodal status (N0, N1, N2, or N3). 

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 successful exploratory Phase 1/2 trials, which demonstrated improved  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

The Galena Biopharma, Inc. logo is available at

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 clinical benefits, expectations, plans and prospects of the development of NeuVax and Galena's other 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

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