Galena Biopharma Receives Two Orphan Drug Designations for GALE-301 and GALE-301/GALE-302

SAN RAMON, Calif., June 10, 2016 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc. (NASDAQ:GALE), a biopharmaceutical company committed to the development and commercialization of targeted oncology therapeutics that address major unmet medical needs, today announced the U.S. Food and Drug Administration (FDA) has granted two orphan-drug designations for Galena’s two cancer immunotherapy peptides derived from Folate Binding Protein (FBP) for the treatment (including prevention of recurrence) of ovarian cancer: one for GALE-301 (E39), and one for GALE-301 (E39) and GALE-302 (E39’). In clinical trials, GALE-301, and GALE-301/GALE-302 are combined with the immune adjuvant, granulocyte macrophage-colony stimulating factor (GM-CSF) for the treatment of ovarian cancer in the adjuvant setting.

“Ovarian cancer is a very aggressive disease with almost fifty percent of women recurring within five years after their initial treatment1,” said Mark W. Schwartz, Ph.D., President and Chief Executive Officer.  “This designation supports our efforts to advance our FBP-targeted immunotherapy program consisting of GALE-301 and GALE-302 to prevent cancer recurrence in this underserved patient population.”

The Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S.2 Orphan designation qualifies the sponsor of the drug for various development incentives including marketing exclusivity in the U.S. for seven years after product approval3, tax credits, and exemption from the prescription drug user fee.

Sources: 1U.S. Ovarian Cancer; 2FDA Website - Developing Products for Rare Diseases & Conditions; 3FDA Frequently Asked Questions on Patents and Exclusivity

About GALE-301 and GALE-302

GALE-301 and GALE-302 are cancer immunotherapies that consist of a peptide derived from Folate Binding Protein (FBP) combined with GM-CSF for the treatment (including prevention of recurrence) of ovarian cancer in the adjuvant setting.  GALE-301 is the E39 peptide, while GALE-302 is an attenuated version of this peptide, known as E39’.  FBP is a well-validated therapeutic target that is highly over-expressed in ovarian, endometrial and breast cancers, and is the source of immunogenic peptides that can stimulate cytotoxic T lymphocytes (CTLs) to recognize and destroy FBP-expressing cancer cells. Two trials are ongoing with FBP peptides in gynecological cancers: the GALE-301 Phase 2a portion of the Phase 1/2a clinical trial is ongoing in ovarian and endometrial adenocarcinomas ( Identifier: NCT01580696); the GALE-301 plus GALE-302 Phase 1b clinical trial is ongoing in breast and ovarian cancers ( Identifier: NCT02019524).

About Ovarian Cancer

New cases of ovarian cancer occur at an annual rate of 12.1 per 100,000 women in the U.S., with an estimated 21,290 cases for 2015. Although ovarian cancer represents about 1.3% of all cancers, it represents about 2.4% of all cancer deaths, or an estimated 14,180 deaths in 2015.  Approximately 1.3% of women will be diagnosed with ovarian cancer at some point during their lifetime (2010 – 2012 data).  The prevalence of ovarian cancer in the U.S. is about 192,000 women, and the five-year survivorship for women with ovarian cancer is 45.6%. 

Due to the lack of specific symptoms, the majority of ovarian cancer patients are diagnosed at later stages of the disease, with an estimated 75% of women presenting with advanced-stage (III or IV) disease. These patients have their tumors routinely surgically debulked to minimal residual disease, and then are treated with platinum- and/or taxane-based chemotherapy. While many patients respond to this treatment regimen and become clinically free-of-disease, the majority of these patients will relapse.  Depending upon their level of residual disease, the risk for recurrence after completion of primary therapy ranges from 60% to 85%.  Unfortunately for these women, once the disease recurs, treatment options are limited and the disease remains incurable.

Source: National Cancer Institute Surveillance, Epidemiology, and End Results Program

About Galena Biopharma

Galena Biopharma, Inc. is a biopharmaceutical company committed to the development and commercialization of targeted oncology therapeutics that address major unmet medical needs. Galena’s development portfolio is focused primarily on addressing the rapidly growing patient populations of cancer survivors by harnessing the power of the immune system to prevent cancer recurrence. The Company’s pipeline consists of multiple mid- to late-stage clinical assets, including novel cancer immunotherapy programs led by NeuVax™ (nelipepimut-S) and GALE-301.  NeuVax is currently in a pivotal, Phase 3 breast cancer clinical trial with several concurrent Phase 2 trials ongoing both as a single agent and in combination with other therapies. GALE-301 is in a Phase 2a clinical trial in ovarian and endometrial cancers and in a Phase 1b given sequentially with GALE-302.   For more information, visit

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 progress of the development of Galena’s product candidates, including GALE-301 and GALE-302, patient enrollment in our clinical trials, as well as other statements related to the progress and timing of our development activities, present or future licensing, collaborative or financing arrangements, expected outcomes with regulatory agencies, and projected market opportunities for product candidates or that otherwise relate to future periods. 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, 2015 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.

CONTACT: Contact:

Remy Bernarda 
SVP, Investor Relations & Corporate Communications
(925) 498-7709