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July 1, 2014
07:07 EDTGALEGalena receives U.S. patent for NeuVax
Galena Biopharma announced the notice of allowance of a U.S. Patent for NeuVax covering the use of NeuVax alone or in combination to prevent recurrence of any HER2/neu expressing tumor having a fluorescence in situ hybridization, or FISH, rating of less than about 2.0. NeuVax is a peptide immunotherapy for the prevention of cancer recurrence and is Galena's lead development agent in multiple ongoing and planned clinical trials. Once issued, the patent will expire in 2028, not including any patent term extensions. FISH is a diagnostic test used to identify patients with high levels of HER2 gene expression, or FISH greater than 2.0. These patients are eligible for existing approved HER2-directed treatments. Currently there are no approved HER2-directed therapies for patients who express lower levels of HER2, or less than 2.0 by the FISH testing scale. The patent will cover the use of NeuVax in patients with a FISH of less then about 2.0, as a stand-alone therapy or in combination with an adjuvant and/or other agents. Importantly, this NeuVax patent provides Galena with coverage for any tumor expressing low-to-intermediate levels of HER2.
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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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