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January 7, 2014
07:16 EDTGALEGalena Biopharma enrolls first patient in GALE-301 phase 2 trial
Galena Biopharma announced the first patient has been enrolled in the phase 2 trial for GALE-301. GALE-301 is a folate receptor alpha-derived, peptide-based cancer immunotherapy administered to HLA-A2 positive patients in combination with granulocyte macrophage-colony stimulating factor as an adjuvant treatment to prevent recurrences in high-risk, endometrial and ovarian cancer patients rendered disease-free after completing standard of care therapy. The primary objective of the trial is to measure immune response, with secondary outcomes of recurrence. "With GALE-301 progressing into its Phase 2 trial, we continue to demonstrate progress of our innovative cancer immunotherapy pipeline," said Mark Ahn, president and CEO. Initial results from the Phase 1 trial determined the optimal dose and showed that GALE-301 was well tolerated and evoked a FBP specific immunological response.
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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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