Sellas Life Sciences announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to WT1 cancer vaccine for the treatment of patients with acute myeloid leukemia (AML).

Recent findings from Phase 1 and 2 trials showed that the WT1 vaccine demonstrated clinically meaningful prolonged survival in AML patients. A median overall survival of around 4 years and >3 years were achieved in a Phase 2 and a Phase 1 trial, respectively. When combined, results from both studies demonstrated a 2-year overall survival rate in adult AML patients of 79%. Positive efficacy and safety data from these trials were presented at the International WT1 Conference held in Kyoto, Japan, in November 2015.

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Based on promising results from the Phase 1 and 2 trials, the Company is anticipating to initiate a double-blind, placebo-controlled, multicenter Phase 3 clinical study to assess the efficacy and safety of the WT1 cancer vaccine in AML patients.

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