Annual Meeting; GALE-301 demonstrates 'promising preliminary efficacy data' with a projected 78% reduction in relative risk of recurrence in the 1000 mcg dose cohort (GALE) : The abstracted titled "Preliminary Results of the Phase I/IIa Dose Finding Trial of a Folate Binding Protein Vaccine (E39+GM-CSF) in Ovarian and Endometrial Cancer Patients to Prevent Recurrence," includes data that show that GALE-301 is well tolerated and elicits a strong and dose-dependent in vivo immune response. The trial is designed as a safety and dose optimization trial and is not powered for a disease free survival efficacy endpoint. However, early efficacy results from the trial are promising in the 1000 mcg dose cohort.
"The use of Leica's Bond Oracle HER2 IHC system ensures we have enrolled the specified HER2 1+/2+ patients for our Phase 3 NeuVax PRESENT trial and moves us further down the path of providing targeted, personalized medicine for these women. Meanwhile, the published preliminary data from our GALE-301 program is quite promising as it shows significant reduction of recurrences with our vaccine. We expect to present more mature data at a scientific conference this Fall, and we are currently evaluating the next steps to potentially advance GALE-301 into a randomized late-stage trial to prevent recurrence in ovarian and endometrial cancers."