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News Breaks
June 2, 2014
07:14 EDTGALEGalena presents GALE-301 Phase 1 data
Galena announced that data from the company's Phase 1 study with GALE-301, or Folate Binding Protein, was presented at the American Society of Clinical Oncology 50th Annual Meeting. The poster entitled, "Comparison of recurrent and nonrecurrent ovarian and uterine cancer patients undergoing adjuvant folate receptor vaccine therapy," was presented during the Gynecologic Cancer General Poster Session. Overall, 30 patients were enrolled in the Phase 1 trial. Of 14 control patients, 50% have recurred. Of 16 vaccinated patients, 25% have recurred after completing the primary vaccine series and 12.5% recurred prior to completing the PVS, and one patient withdrew. Of note, no recurrences have been seen in the optimal dose cohort of 1000 mcg E39. The vR patients displayed lower mean delayed type hypersensitivity reactions as well as lower local reactions at every measured time point. The company said, "These promising initial results demonstrate the vaccine is dose responsive with the immune system and we are encouraged about the potential for this compound to prevent recurrence in women suffering from high risk gynecological cancers where current treatment options are limited. The data from this study served as the basis for advancing GALE-301 into its ongoing Phase 2 trial that includes a booster regimen. We expect enrollment in this trial to complete shortly, ahead of schedule."
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April 21, 2015
09:34 EDTGALEGalena sent FDA warning letter following site inspection
A warning letter published by the FDA, dated April 3, states that the agency's inspection of Galena Biopharma's site in Portland, Oregon, conducted between November 17 and 21, 2014, revealed "serious violations" of FDAs PADE reporting requirements. Reference Link
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.

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