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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.
News For GALE From The Last 14 Days
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December 11, 2014
08:40 EDTGALEGalena presents HER2 screening data results from NeuVax Phase 3 clinical trial
Galena Biopharma announced that initial immunohistochemistry, or IHC, screening data from 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, trial was presented at the 2014 San Antonio Breast Cancer Symposium, or SABCS. The poster, entitled, "HER2 Discordant Results in Local vs. Central Testing in the Phase 3 Nelipepimut-S Trial and Implementation of Leica Bond Oracle HER2 Immunohistochemistry System for Low and Intermediate Levels of HER2 Protein Expression as a Companion Diagnostic," demonstrated that with the implementation of the Leica Bond Oracle HER2 IHC assay, preliminary limited data indicated additional patients met HER2 eligibility for PRESENT and the assay identified more precisely patients at HER2 1+ and 2+. As part of the PRESENT trial, Galena has implemented central laboratory testing for all potential patients to confirm validated and robust entry criteria, and ensure the enrollment of the targeted patient population. To improve accuracy and specificity for the HER2 1+ and 2+ status testing, and develop a companion diagnostic for NeuVax, the Leica Bond Oracle HER2 IHC system has been incorporated as central HER2 IHC screening for the PRESENT study.
December 8, 2014
09:20 EDTGALEOn The Fly: Pre-market Movers
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07:08 EDTGALEGalena GALE-401 Phase 1 results show reduced platelet counts, tolerable safety
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