Galena Biopharma Expands Folate Binding Protein Vaccine Intellectual Property With Notice of Allowance for U.S. Patent

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Galena Biopharma Expands Folate Binding Protein Vaccine Intellectual Property With Notice of Allowance for U.S. Patent

 

• Composition of Matter patent covers FBP peptide variants for individual or expanded use in combination with the FBP vaccine, E39.
• Provides exclusivity until 2029, not including any patent term extensions.
• Patent also protects new methodology of peptide vaccination with wide applicability.

 LAKE OSWEGO, Ore., May 1, 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 Composition of Matter patent covering Folate Binding Peptide (FBP) peptide variants for use either alone or in combination with the FBP vaccine, E39. Additionally, the patent lays the foundation for additional intellectual property for the use of these variants in a novel vaccination strategy that could be applied to any peptide-based vaccine.

 "This patent further supports Galena's overall strategy to develop targeted peptide cancer vaccines to prevent or delay cancer recurrence in early stage, adjuvant patients," said Mark J. Ahn, Ph.D., President & Chief Executive Officer. "Folate targeted therapies are well validated by the industry, and we are excited to continue our work in pursing trials in cancer survivors at high risk for relapse before their disease is detected as metastatic."

 Galena's current FBP vaccine, E39, is in an ongoing Phase 1/2 trial in two gynecological cancers: ovarian and endometrial adenocarcinomas. The company has already designed a new Phase 1b trial studying the benefit of these FBP peptide variants in combination with E39 that is awaiting Institutional Review Board (IRB) approval.

About Folate Binding Protein (FBP)

 Folate binding protein (FBP) is highly over-expressed in breast, ovarian and endometrial cancers and is a well-validated therapeutic target. FBP is the source of immunogenic peptides like E39 that can stimulate cytotoxic T lymphocytes (CTL) to recognize and destroy preclinical FBP-expressing cancer cells. The FBP vaccine consists of the FBP peptide(s) combined with the immune adjuvant, granulocyte macrophage-colony stimulating factor (GM-CSF). Galena's FBP vaccine, E39, is currently in a Phase 1/2 trial in two gynecological cancers: ovarian and endometrial adenocarcinomas.

About Ovarian/Endometrial Cancers

 Ovarian cancer occurs in over 22,000 patients per year in the U.S. and is the most lethal gynecologic cancer. Despite the incidence of ovarian cancer being only approximately 20% that of breast cancer, the number of patients that die from ovarian cancer is nearly 50% that of breast cancer. Due to the lack of specific symptoms, the majority of ovarian cancer patients are diagnosed at later stages of the disease. These patients are routinely surgically debulked to minimal residual disease, and then treated with platinum- and/or taxane-based chemotherapy. While most patients respond to this treatment regime and become clinically free of disease, the majority of these patients will relapse, and once the disease recurs, the treatment options and successes drop dramatically.

 Endometrial cancer is the most common gynecologic cancer and occurs in over 46,000 women, with over 8,000 deaths, in the U.S. annually. There are two basic types of endometrial cancer: endometriod and papillary serous. The latter has a much more aggressive clinical course and the majority of these patients will die of this form of the disease.

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 and the development of Galena's product candidates. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those detailed from time to time in Galena's filings with the SEC. 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.
CONTACT: Madeline Hatton

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         Remy Bernarda

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