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FDA Grants Fast Track Designation for Mocravimod in Combination with HSCT for AML

AML cells

The U.S. Food and Drug Administration (FDA) granted Fast Track Designation for mocravimod in combination with allogeneic hematopoietic stem cell transplant (HSCT) for post-remission therapy of acute myeloid leukemia (AML).

Mocravimod is a synthetic, sphingosine 1-phosphate receptor modulator that has been assessed in phase I and II trials for safety and tolerability, as well as for efficacy in several autoimmune indications. Promising data from a phase Ib/IIa clinical study in patients with hematological malignancies led the drug’s manufacturer, Priothera, to further develop mocravimod for the treatment of blood cancers.

Priothera plans to initiate the phase IIb/III MO-TRANS study in Europe, the United States, and Japan to assess the efficacy and safety of mocravimod as an adjunctive and maintenance therapy in adult AML patients undergoing allogeneic HSCT. The study is expected to begin in the second half of 2022, and preliminary data are expected by the end of 2024.

Source: Priothera Press Release, May 2022

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