Galena Biopharma (RXII) Announces Investigational New Drug Approval for Phase 2 Trial for NeuVax(TM) (E75 + GM-CSF) Combined With Herceptin(R) (trastuzumab)
1/5/2012 9:53:37 AM
LAKE OSWEGO, Ore., Jan. 5, 2012 (GLOBE NEWSWIRE) -- Galena Biopharma (Nasdaq:GALE), a biotechnology company focused on developing innovative, targeted oncology treatments addressing major unmet medical needs to advance cancer care, today announced that the U.S. Food and Drug Administration has approved the Investigational New Drug (IND) application for the Phase 2 combination trial with NeuVax™ (E75 plus GM-CSF) and Herceptin® (trastuzumab; Genentech/Roche). The trial is being funded by Galena Biopharma and Genentech/Roche through the Henry M. Jackson Foundation. Each company will provide their respective drugs for the 300 patient trial and approximately half of the funding necessary to complete the trial. The trial will be conducted at twenty sites worldwide and is expected to commence in the first half of 2012 under the direction of COL George E. Peoples, M.D., FACS, Director, Cancer Vaccine Development Program; Deputy Director, United States Military Cancer Institute; Professor (adjunct), Surgical Oncology, M.D. Anderson Cancer Center; Professor, Surgery, Uniformed Services University; Chief, Surgical Oncology, Brooke Army Medical Center.