Galena Biopharma Announces Clinical Development Collaboration With Genentech/Roche and The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) for NeuVax(TM) (E75) Combined With Herceptin(R) (trastuzumab) in Adjuvant Breast Cancer
Under the terms of the collaboration, Genentech and Galena will sponsor a randomized, blinded multicenter Phase 2 clinical study in adjuvant breast cancer in approximately 300 patients, scheduled to be initiated in the first half of 2012. Clinical studies presented by Galena Biopharma at the American Society of Clinical Oncology meeting in June 2011 demonstrated promising results of NeuVax in combination with Herceptin in preventing breast cancer recurrences.
"Trastuzumab has been a breakthrough treatment for breast cancer patients and has clinically validated the HER2 target, yet only addresses 25% of HER2 positive breast cancer patients," stated COL George E. Peoples, MD, 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 (BAMC). "The combination use of NeuVax with Herceptin may expand the use of both products to the remaining 75% of low-to-intermediate HER2+ patients currently not eligible to receive Herceptin therapy. Furthermore, this trial may provide confirmation data of a synergistic effect of the combination that may also extend to those patients already eligible for Herceptin."
"We are excited about collaborating with Genentech/Roche and The Henry M. Jackson Foundation to explore the combination of NeuVax and Herceptin," commented Mark J. Ahn, PhD, President and CEO of Galena Biopharma. "The potential to expand on our upcoming Phase 3 program, as well as the validation of NeuVax by a leading biopharmaceutical company, continues to build value for patients and shareholders."
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: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.
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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 HattonToll free: +1 (855) 855-GALE (4253), ext. 109info@galenabiopharma.comorRemy BernardaIR Sense, LLC+1 (503) 400-6995remy@irsense.com