Gloucester Presents Positive Results From Phase IIb Lymphoma Trial
Posted on: Tuesday, 20 May 2008, 09:01 CDT
Gloucester Pharmaceuticals has reported positive results from a Phase IIb registration trial of romidepsin in patients with advanced cutaneous T-cell lymphoma.
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."
Source: Datamonitor
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