Celgene reported Thursday that a Phase 1 study of its immunomodulatory therapy consisting of human placenta-derived cells, PDA-001, demonstrated clinical benefit, including clinical remission, in patients with treatment-resistant Crohn's disease.
Data from the study, which involved 12 patients with active moderate-to-severe Crohn's disease, show that four of the six participants given the lowest infusion dose of the therapy experienced clinical remission, according to the drugmaker. Additionally, the trial met its primary endpoint of safety.
Celgene said it plans to begin Phase II studies of the compound in other indications to further evaluate its clinical potential.
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