Galena Biopharma Announces IND for Phase 2 Trial for NeuVax Combined With Herceptin
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Galena Biopharma (Nasdaq: GALE) 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.
From previously published results, NeuVax has shown a decreased recurrence rate in breast cancer patients with HER2 low-expressing tumors. Furthermore, the combination of trastuzumab and NeuVax has been shown to be synergistic with the potential for even better clinical results. This prospective, randomized trial will enroll 300 breast cancer patients with HER2 low-expressing tumors in order to establish the benefit of the combination versus trastuzumab alone in the adjuvant setting.
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.
From previously published results, NeuVax has shown a decreased recurrence rate in breast cancer patients with HER2 low-expressing tumors. Furthermore, the combination of trastuzumab and NeuVax has been shown to be synergistic with the potential for even better clinical results. This prospective, randomized trial will enroll 300 breast cancer patients with HER2 low-expressing tumors in order to establish the benefit of the combination versus trastuzumab alone in the adjuvant setting.
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