- Allowed claims will cover the use of NeuVax alone or in combination to prevent recurrence of any breast cancer tumor expressing low-to-intermediate levels of HER2 - Extends patent coverage to three main markets, U.S., EU and now Japan PORTLAND, Ore., Oct. 14, 2014 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc. (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that that address major medical needs across the full spectrum of cancer care, today announced the notice of allowance from the Japanese Patent Office for NeuVax™ (nelipepimut-S) covering the use of NeuVax alone or in combination with other agents to prevent recurrence of any HER2/neu expressing breast cancer tumor having an immunohistochemistry (IHC) level of 1+ or 2+, or a fluorescence in situ hybridization (FISH) rating of less than about 2.0. NeuVax is a peptide immunotherapy for the prevention of cancer recurrence and is Galena's lead development agent in multiple ongoing and planned clinical trials. Once issued, the patent will expire in 2027, not including any patent term extensions. "With this patent, we now have coverage in the three largest potential breast cancer markets for NeuVax: the United States, Europe, and Japan," said Mark W. Schwartz, Ph.D., President and Chief Executive Officer. "The incidence of breast cancer in Japan continues to increase, and this claim provides Galena with coverage for any breast cancer tumor expressing low-to-intermediate levels of HER2 either as a stand-alone therapy, or in combination with other agents." The claims cover the use of NeuVax alone or in combination with an adjuvant and/or other agents (e.g. other drugs such as Herceptin ® (trastuzumab; Genentech/Roche)) to treat breast cancer in patients with IHC 1+ or 2+ levels or with FISH of less than about 2.0. IHC and FISH are diagnostic tests used to identify patients with high levels of HER2 gene expression, or IHC 3+ or FISH greater than 2.0. These patients are eligible for existing approved HER2-directed treatments. Currently there are no approved HER2-directed therapies for patients who express lower levels of HER2, or less than 2.0 by the FISH testing scale. About NeuVax™ (nelipepimut-S) NeuVax™ (nelipepimut-S) is the immunodominant peptide derived from the extracellular domain of the HER2 protein, a well-established target for therapeutic intervention in breast carcinoma. The nelipepimut-S sequence stimulates specific CD8+ cytotoxic T lymphocytes (CTLs) 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-S immune response can also generate CTLs to other immunogenic peptides through inter- and intra-antigenic epitope spreading. NeuVax is currently in an international, Phase 3 PRESENT ( Prevention of Recurrence in Early- Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) study under a Special Protocol Assessment (SPA) granted by the U.S. Food and Drug Administration (FDA). Additional information on the PRESENT trial can be found at www.neuvax.com. A randomized, multicenter investigator sponsored, 300 patient Phase 2b clinical trial is also enrolling patients to study NeuVax in combination with Herceptin ® (trastuzumab; Genentech/Roche). About Galena Biopharma Galena Biopharma, Inc. (Nasdaq:GALE) is a biopharmaceutical company developing and commercializing innovative, targeted oncology therapeutics that address major medical needs across the full spectrum of cancer care. Galena's development portfolio ranges from mid- to late-stage clinical assets, including a robust immunotherapy program led by NeuVax™ (nelipepimut-S) currently in an international, Phase 3 clinical trial. The Company's commercial drugs include Abstral ® (fentanyl) Sublingual Tablets and Zuplenz ® (ondansetron) Oral Soluble Film. Collectively, Galena's clinical and commercial strategy focuses on identifying and advancing therapeutic opportunities to improve cancer care, from direct treatment of the disease to the reduction of its debilitating side-effects. For more information, visit 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 issuance of patents based on Notices of Allowance from the Japan Patent Office, the scope of patent protection for the company's product candidates afforded by any patents if issued, and the progress and development of Galena's product candidates in clinical trials, as well as statements about our expectations, plans and prospects. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those identified under "Risk Factors" in Galena's Annual Report on Form 10-K for the year ended December 31, 2013 and most recent Quarterly Reports on Form 10-Q filed 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 press release. NeuVax™ is a trademark of Galena Biopharma, Inc. Other trademarks are the property of their respective owners.
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