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Pharmacyclics Reports Fourth Quarter and Full Year Fiscal 2012 Financial Results and Recent Developments
Date:9/5/2012

l survival rate and other measures of clinical benefit. This study, initiated by Janssen, will be conducted outside the US and Janssen plans to enroll 280 patients.
  • Phase II study of ibrutinib in patients with mantle cell lymphoma who progress after bortezomib therapy: A single-arm, multi-center Phase II trial of ibrutinib as a monotherapy in relapsed/refractory MCL patients who received at least one prior rituximab-containing chemotherapy regimen and who progressed after bortezomib therapy. The primary endpoint of the study is overall response rate. The key secondary endpoints include duration of response, progression-free survival rate, and other measures of clinical benefit. This global study, conducted by Janssen, is open and Janssen plans to enroll 110 patients worldwide.
  • Phase II dose escalating study of ibrutinib in combination with R-CHOP in patients with newly diagnosed diffused large B-cell lymphoma (DLBCL): The purpose of this study is to identify if, and at what dose, ibrutinib may be administered with R-CHOP and to document responses of this combination in patients with newly diagnosed DLBCL. This multi-center global study, conducted by Janssen, is open and Janssen plans to enroll up to 42 patients.
  • Phase II study of ibrutinib in subjects with relapsed or refractory multiple myeloma (MM): This is a Phase II, open-label, nonrandomized designed trial to assess the safety and efficacy of ibrutinib in subjects with relapsed or relapsed and refractory MM. This multi-center study, conducted by PCYC, is open in the US and we plan to enroll up to 35 subjects.
  • Clinical Updates planned at a medical meeting by the end of 2012:

  • PCYC-04753, Phase I study of single agent ibrutinib in patients with recurrent B-cell malignancies. The update will focus on the cohort of evaluable patients with follicular lymphoma.
  • PCYC-1102, Phase Ib/II study of single agent ibrutinib in patients with relapsed or refrac
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