Gloucester presents positive results from Phase IIb lymphoma trial

The primary endpoint of the registration trial, objective disease response rate (ORR) in patients who had failed previous therapy, was successfully achieved with an ORR of 40.3% (29/72 of evaluable patients). And 33.3% (24/72) of patients experienced a partial response (PR) and 6.9% (5/72) of patients achieved a complete response. Additionally, 92% (48/52) of patients with pruritus (intense itching) at the outset of the trial had some relief from their pruritus.

Alan Colowick, CEO of Gloucester Pharmaceuticals, said: “The positive outcome of this registration study reinforces our commitment to submit for US marketing approval of romidepsin in patients with cutaneous T-cell lymphoma later this year.”