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Pharmacyclics Reports First Quarter 2013 Results
Date:5/1/2013

bination with bendamustine and rituximab in R/R CLL/SLL patients who received at least one line of prior systemic therapy. The primary endpoint of the study is to demonstrate a clinically significant improvement in progression-free survival when compared to bendamustine and rituximab. This global study, conducted by Janssen, is open and Janssen plans to enroll 580 patients worldwide.
  • Phase II study, RESONATE™-17, which is 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. This global study is open and Pharmacyclics plans to enroll 111 patients worldwide. The Company plans to complete enrollment for this study before year end 2013.
  • Phase III study of ibrutinib versus temsirolimus in R/R MCL patients, RAY (MCL3001). This trial is a randomized, multi-center, open-label trial of ibrutinib as a monotherapy versus temsirolimus in R/R MCL patients who received at least one prior rituximab-containing chemotherapy regimen. The primary endpoint of the study is progression-free-survival when compared to temsirolimus. This global study, conducted by Janssen outside the US, is open and Janssen plans to enroll 280 patients.
  • Phase III study of ibrutinib in combination with bendamustine and rituximab in patients with newly diagnosed MCL, SHINE (MCL3002). This trial is a randomized, multi-center, double-blinded, placebo-controlled trial of ibrutinib plus bendamustine and rituximab versus placebo plus bendamustine and rituximab in patients with newly diagnosed MCL. The primary endpoint of the study is progression-free-survival when compared to bendamustine and rituximab. Janssen plans to enroll 520 patients in this study.
  • Phase II study of ibrutinib in patients with R/R MCL who progress after bortezomib therapy,
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  • SOURCE Pharmacyclics, Inc.
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