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April 28, 2014
07:21 EDTGALEGalena announces Defense Department grant for NeuVax clinical trial
Galena announced the Department of Defense will provide funding towards a new clinical trial with NeuVax to prevent breast cancer recurrence in high-risk HER2 3+ patients. The grant, a Breast Cancer Research Program Breakthrough Award, was obtained by Elizabeth A. Mittendorf, M.D., Associate Professor, Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center who will oversee the investigator-sponsored trial. Galena will support the trial with study drug and funding and will have access to the research to support ongoing registrational studies. The protocol for the multi-center, prospective, randomized, single-blinded Phase 2 trial is being finalized and is expected to enroll approximately 100 patients with a diagnosis of HER2 3+ breast cancer who are HLA A2+ or HLA A3+ and are determined to be at high-risk for recurrence.
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August 24, 2015
07:07 EDTGALEIDMC recommends reduction of cardiac toxicity monitoring in Galena NeuVax trial
Galena Biopharma announced that the Independent Data Monitoring Committee, or IDMC, has recommended to the company that it can reduce the cardiac toxicity monitoring for patients in its NeuVax Phase 3 Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment, or PRESENT, clinical trial. The trial is being run under a Special Protocol Assessment, or SPA, approved by the FDA. Following its most recent IDMC meeting in June, the IDMC recommended routine cardiac monitoring could be reduced in the PRESENT trial and that such a reduction is justified and consistent with the pre-specified Cardiac Toxicity Monitoring Stopping Rules defined in the study protocol. The IDMC concluded that cardiac toxicity monitoring by echocardiogram, or ECHO, or multiple-gated acquisition, or MUGA, scans could be reduced. The IDMC had no other suggestions and recommended the trial continue as planned.

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