Sellas Life Sciences Group, Inc. (SLS), Thursday announced positive interim analysis results for its Phase 3 REGAL trial of galinpepimut-S or GPS in acute myeloid leukemia.
The analysis was conducted by the Independent Data Monitoring Committee or IDMC, which recommended trial continuation without any modifications after reviewing 60 death events in the study population.
The analysis found that less than fifty percent of enrolled patients deceased after the median follow-up period of 13.5 months, indicating a median survival of over 13.5 Months in the trial vs. historical median survival of 6 months for conventional therapy.
Additionally, 80 percent of randomly selected GPS patients showed specific T-Cell immune response, exceeding the results shown in the previous Phase 2 study.
The final analysis will be conducted on reaching 80 death events, which is expected to reach this year.
The biotechnology company added that it is preparing for Biologics License Application.
Currently, SELLAS's stock is falling 14.61 percent, to $0.97 on the Nasdaq.
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