Galena Biopharma Issued NeuVax(TM) U.S. Patent
Patent strengthens NeuVax Intellectual Property position for treating Phase 3 target population of low-to-intermediate (IHC 1+/2+) HER2 patients.
Provides NeuVax exclusivity for this indication until 2028, not including any patent term extensions.
LAKE OSWEGO, Ore., July 18, 2012 -- Galena Biopharma, Inc. (Nasdaq:GALE), a biotechnology company focused on developing innovative, targeted oncology treatments, today announced the issuance of a key patent, originally allowed in March 2012, from the U.S. Patent and Trademark Office (USPTO) covering the use of its product candidate, NeuVax™, a HER2/neu peptide vaccine, for inducing immunity to breast cancer recurrence in patients having low-to-intermediate IHC levels of 1+ or 2+ and a FISH rating of less than 2.0. These patients represent a significant unmet medical need, with as much as 80% of breast cancer patients who do not qualify for Herceptin® therapy.
"As we continue to make progress with the clinical development of NeuVax, issuance of this patent from the USPTO underscores our commitment to support and advance our proprietary oncology pipeline," stated Mark J. Ahn, Ph.D., President and CEO.
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 that achieved its primary endpoint of disease-free survival, the Food and Drug Administration granted NeuVax a Special Protocol Assessment 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 ongoing and additional information on the study can be found at www.neuvax.com.
According to the National Cancer Institute, over 230,000 women in the U.S. are diagnosed with breast cancer annually. Of these women, about 75% of them have breast cancer tissue that tests positive for some level of HER2 staining (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 $6 billion in 2011. NeuVax targets the 50-60% of patients with tumors that stain low or intermediate for HER2 (HER2 1+ and 2+), who would not receive Herceptin after they successfully complete their surgery, adjuvant chemotherapy and radiation. This provides this large group of early-stage breast cancer patients an option for a HER2-targeted adjuvant treatment 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.
The Galena Biopharma, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=10647
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 significance of the allowed patent. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including the risks set forth in Galena's most recent annual report on Form 10-K and quarterly reports on Form 10-Q.
CONTACT: Madeline Hatton
Toll-free: +1 (855) 855-GALE (4253), ext. 109