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PDL BioPharma Advances Nuvion® Into Second Pivotal Study In Intravenous Steroid-Refractory Ulcerative Colitis
Last Updated: April 26, 2007
PDL BioPharma, Inc. (PDL) (Nasdaq: PDLI) today announced that the company will advance its Nuvion® (visilizumab) antibody in patients with intravenous steroid-refractory ulcerative colitis (IVSR-UC) into a phase three program. Advancement of the program follows guidance from an independent external Data Monitoring Committee (DMC) based on a planned safety and futility assessment of data from 60 patients enrolled in an ongoing phase 2/3 clinical trial of the Nuvion antibody in patients with IVSR-UC. As a result, the company will continue with enrollment in this ongoing phase 2/3 trial, known as RESTORE 1, while starting a second pivotal trial in the same patient population, known as RESTORE 2. Date Posted: May 17, 2007 |
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