SAN RAMON, Calif., Jan. 05, 2017 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc. (NASDAQ:GALE), a biopharmaceutical company committed to the development and commercialization of hematology and oncology therapeutics that address unmet medical needs, today provided a corporate and clinical outlook for 2017 and announced that Mark W. Schwartz, Ph.D., President and Chief Executive Officer will give a company presentation at the Biotech Showcase 2017. The presentation will take place on Wednesday, January 11, 2017 at 10:30 a.m. PT at the Hilton San Francisco Union Square. The presentation will be webcast and available on the Investors section of the Company's website at http://investors.galenabiopharma.com/events.cfm.
“2017 looks to be promising for Galena Biopharma as we prepare to initiate our Phase 3 clinical trial in patients with essential thrombocythemia (ET) with GALE-401, our controlled release version of anagrelide,” said Mark W. Schwartz, Ph.D., President and Chief Executive Officer. “After a productive meeting with the U.S. Food and Drug Administration (FDA) last month, we were pleased to confirm that the GALE-401 development program is appropriate for a New Drug Application (NDA) filing using the 505(b)(2) regulatory pathway in patients who are intolerant to or failed to achieve an optimal response with hydroxyurea. In the U.S., ET has a prevalence of approximately 150,000 people and we estimate up to 25% of those patients who receive initial treatment with hydroxyurea may be candidates for the GALE-401 trial. We expect to finalize the details of the Phase 3 clinical trial protocol including the trial size, endpoints, and dosing this quarter and initiate the trial in the second quarter of 2017.”
Read more: https://globenewswire.com/news-release/2017/01/05/903607/0/en/Galena-Biopharma-to-Provide-Corporate-and-Clinical-Update-and-2017-Outlook-During-Presentation-at-Biotech-Showcase-2017.html