March 20, 2012

Galena Biopharma Strengthens NeuVax(TM) Intellectual Property Position With Notice of Allowance for U.S. Patent

  • Patent covers the use of NeuVax 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., March 20, 2012 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc. (Nasdaq:GALE), a biotechnology company focused on developing innovative, targeted oncology treatments, today announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for a patent 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 ratings of 1+ or 2+ and a FISH rating of less than about 2.0. These patients represent a significant unmet medical need, with as much as 50-75% of breast cancer patients who do not qualify for Herceptin® therapy.

"This NeuVax patent reinforces its pioneering role in advancing treatment to reduce recurrence rates for breast cancer survivors," stated Mark J. Ahn, Ph.D., President and CEO. "This addition to our global portfolio allows us to further strengthen our value proposition and explore additional uses for NeuVax to advance care and build value for patients and shareholders."

About NeuVax™

NeuVax™ is a peptide-based immunotherapy intended to reduce the recurrence of breast cancer in low-to-intermediate HER2-positive breast cancer patients not eligible for trastuzumab (Herceptin®; Genentech/Roche). NeuVax is an immunotherapy that stimulates the immune system to actively seek out and selectively kill cancer cells. NeuVax directs "killer" T-cells to target and destroy cancer cells that express HER2/neu, a protein associated with epithelial tumors in breast, ovarian, pancreatic, colon, bladder and prostate cancers. NeuVax has been shown to be most effective in patients with low-to-intermediate HER2/neu expressers with HLA type A2+ or A3+. We believe that approximately 25,000-40,000 of the approximately 200,000 women diagnosed with breast cancer in the United States each year meet these criteria.

NeuVax is comprised of two components: a HER2/neu-derived peptide called E75 and the immune adjuvant GM-CSF. E75 is a nine‑amino acid sequence that is immunogenic (produces an immune response) and GM-CSF is a commercially available protein that acts to stimulate and activate components of the immune system such as macrophages and dendritic cells.

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). NeuVax targets the remaining 50% of the low-to-intermediate HER2 breast cancer patients (often referred to as HER2-negative, not eligible for Herceptin) 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.

The Galena Biopharma, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=10647

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 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

         info@galenabiopharma.com

         

         or

         

         Remy Bernarda

         IR Sense, LLC

         +1 (503) 400-6995

         remy@irsense.com


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