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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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April 14, 2015
07:26 EDTGALEGalena completes over-enrollment of NeuVax Phase 3 PRESENT clinical trial
Galena Biopharma announced the completion of enrollment in the NeuVax Phase 3 PRESENT, or Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment, clinical trial. NeuVax is a first-in-class, HER2-directed cancer immunotherapy under evaluation to prevent breast cancer recurrence after standard of care treatment in the adjuvant setting. As anticipated, Galena over-enrolled the trial by 7.7% with a total of 758 patients now in the intent-to-treat, or ITT, population. The protocol for the PRESENT trial, being conducted under an FDA approved Special Protocol Assessment, or SPA, called for 700 patients; and, the company expects this higher number of ITT patients will increase the confidence in both the timing and quality of the statistics and the final outcome of the trial. The primary endpoint is currently expected to be reached in 2018, after the last patient dosed reaches her 36th month of treatment, or a total of 141 events occur, whichever comes later.
April 9, 2015
17:46 EDTGALEGalena receives warning letter from FDA
Galena disclosed the following in a regulatory filing: "As previously reported by Galena Biopharma in its Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on March 5, following an inspection of our Portland, Oregon facility in November, the U.S. Food and Drug Administration issued a Form 483 Notice of Inspectional Observations noting deficiencies pertaining to post-marketing adverse drug experience reporting and current good manufacturing practices for Abstral and Zuplenz, our only approved products. We responded to the Form 483 Notice in a letter dated December 11, 2014. In conjunction with our response to the FDA, we initiated a number of programs and corrective actions to address the FDA's observations. On April 6, we received a Warning Letter from the FDA relating to certain of the matters originally identified in the Form 483 Notice. Specifically, the Warning Letter cites deficiencies in our response letter related to the adequacy of our written procedures for the surveillance, receipt, evaluation, and reporting of post-marketing adverse drug experiences from all sources, and the failure to report each adverse drug experience not reported under 21 CFR 314.80(c)(1)(i) at quarterly intervals."

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