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 treatment,” 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. 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.
Read more: https://globenewswire.com/news-release/2016/06/10/847799/0/en/Galena-Biopharma-Receives-Two-Orphan-Drug-Designations-for-GALE-301-and-GALE-301-GALE-302.html