Galena Biopharma Reports Third Quarter 2016 Financial Results And Provides A Corporate Update

  • GALE-401 expected to initiate a Phase 3 clinical trial in Q2, 2017
  • Top-Line results from NeuVax™ (nelipepimut-S) PRESENT Clinical Trial
  • Webcast and conference call today at 2:00 p.m. P.T. / 5:00 p.m. E.T.

SAN RAMON, Calif., Nov. 09, 2016 (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 reported its financial results and provided a corporate update for the quarter ended September 30, 2016.

"Over the past several weeks we have collaborated with regulatory experts and world leaders in the treatment of myeloproliferative neoplasms on key elements of the trial design for our pivotal, Phase 3 trial that we expect to initiate in the second quarter of 2017," said Mark W. Schwartz, Ph.D., President and Chief Executive Officer.  "Essential thrombocythemia is a chronic condition in patients presenting with elevated platelets and the limited available treatment options often include challenging side effects. We believe that GALE-401, our controlled release version of anagrelide, could be both effective at lowering platelets and improve the side effect profile from the immediate release version currently available."

As previously announced, Galena discontinued its NeuVax™ (nelipepimut-S) Phase 3 PRESENT ( Prevention of Recurrence in Early- Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) clinical trial due to futility in accordance with the recommendation from the Independent Data Monitoring Committee (IDMC). On today's call, management will present the top-line data from the trial and its assessment of the results.  

Dr. Schwartz continued, "With a better understanding of the interim data in the PRESENT trial, we have the knowledge and experience to guide our immunotherapy programs through clinical development, reinforcing my belief and confidence in our pipeline. As the cancer immunotherapy field focuses on combination treatments, we continue to advance our NeuVax plus trastuzumab clinical trials and evaluate additional indications where NeuVax may benefit patients in combination with other agents.  Similarly, our GALE-301 and GALE-302 trials remain ongoing with two additional data presentations this year."

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