EU orphan designations for Bellicum's BPX-501 T-cell therapy and activator agent rimiducid

5 August 2016

USA-based Bellicum Pharmaceuticals (Nasdaq: BLCM) has received orphan drug designations from the European Commission for both its lead T-cell therapy product candidate BPX-501 to treat hematopoietic stem cell transplantation (HSCT), and for activator agent rimiducid for the treatment of Graft versus Host Disease (GvHD).

The news comes after, earlier this year, BPX-501 and rimiducid received orphan drug status from the US Food and Drug Administration (FDA) as a combination therapy.

Bellicum has also announced that it has met with European regulators to discuss the potential approval pathway for BPX-501 and rimiducid to treat immune-deficiency and GvHD following a haploidentical HSCT in pediatric patients with leukemias, lymphomas and rare inherited blood diseases who do not have a matched donor.

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