Galena Biopharma Presents NeuVax Phase 1/2 Boosters Improve Disease-Free Survival at 60-Month Median Follow-Up
Galena Biopharma (Nasdaq: GALE) presented data from the Phase 1/2 clinical trial of NeuVax™ (E75) at the American Society of Clinical Oncology (ASCO) 2012 Annual Meeting being held June 1-5, 2012 in Chicago, Illinois. The poster entitled, "Safety and Long-Term Maintenance of Anti-HER2 Immunity Following Booster Inoculations of the E75 Breast Cancer Vaccine" (Abstract #2529) was presented on Saturday, June 2, 2012 and was selected for the oral session, "Developmental Therapeutics — Clinical Pharmacology and Immunotherapy."
The Phase 1/2 clinical trials evaluated the NeuVax (E75) vaccine, an HLA A2/A3 restricted HER2/neu (HER2) peptide, mixed with GM-CSF. The trials (SN-33 (Node Positive) and SN-34 (Node Negative)) evaluated a combined 187 patients and have completed a median 60-months of follow-up, with the final patients expected to complete their booster treatments and final follow-up visits by September 2012. The final data analysis is expected to be reported in the fourth quarter of this year.
Initially, patients in the trials were given a series of up to six inoculations of NeuVax dosed once a month. As the trials progressed, the physicians noticed that E75-specific immunity waned after this initial monthly Primary Vaccine Series (PVS) and translated to late recurrences of cancer in some patients. This declining immunity was identified by monitoring the level of CD8 T-cells in each of the patients. Through this evaluation, it became clear that immunological boosters would keep the level of circulating E75-specific CD8+ T cells elevated during the conduct of the trial. As a result of this finding, a voluntary booster program was added to the trials to maintain long-term immunity following the initial monthly PVS.
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