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Pharmacyclics Reports Second Quarter 2013 Results
Date:7/31/2013

th R/R CLL/SLL. This trial is a randomized, multi-center, open-label Phase III trial of ibrutinib as a monotherapy. The enrollment of 391 patients was completed more than two quarters ahead of schedule in April, 2013. The primary endpoint of this study is to demonstrate a clinically significant improvement in progression-free survival (PFS) when compared to ofatumumab. A pre-defined number of progression events will trigger an interim analysis. Pharmacyclics expects a read out from the interim analysis during Q1 of 2014. If the treatment effect of ibrutinib in comparison to ofatumumab is deemed statistically favorable by an independent review committee, a discussion with the FDA and other health authorities for a potential early filing may take place.
  • RESONATE™-17 (PCYC-1117): Phase II study of ibrutinib in a single-arm, open-label, multi-center trial using ibrutinib as a monotherapy in patients who have deletion 17p and who did not respond to or relapsed after at least one prior treatment (a high unmet need population). The primary endpoint of the study is the overall response rate (ORR). This global study has just completed enrollment more than two quarters ahead of schedule. Pharmacyclics plans to announce top-line data from this study in the first half of 2014.
  • RESONATE™-2 (PCYC-1115): Phase III study of ibrutinib versus chlorambucil in frontline newly diagnosed elderly CLL/SLL patients. This trial is a randomized, multicenter, open-label study of ibrutinib as a monotherapy versus chlorambucil in patients 65 years or older with treatment naive CLL/SLL. The study design, which was granted a Special Protocol Assessment (SPA), is designed to demonstrate superiority of ibrutinib with the primary endpoint of PFS when compared to chlorambucil. The study is currently recruiting and Pharmacyclics plans to enroll 272 patients worldwide, with an enrollment completion target by the end of Q3 of 2014.
  • HELIOS (CLL3001): Phase II
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  • SOURCE Pharmacyclics, Inc.
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