Investigational Myelofibrosis Therapy Designated Fast Track Status
Promedior announced that the Food and Drug Administration (FDA) has granted Fast Track designation to PRM-151 for the treatment of myelofibrosis. The Fast Track designation covers primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis. PRM-151 is a recombinant form of Pentraxin-2 (PTX-2), that acts as a monocyte/macrophage differentiation factor to prevent and potentially reverse fibrosis.
Preliminary data from a Phase 2 study of PRM-151 demonstrated benefits across all clinically relevant measures of myelofibrosis, including decreases in bone marrow fibrosis, symptom responses, improvements in hemoglobin and platelets, and reductions in spleen size, with a well-tolerated safety profile and no treatment related myelosuppression.
Previously in September 2014, PRM-151 was granted Orphan Drug designation for myelofibrosis.
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