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Pharmacyclics Reports Results for Six and Three Months Ended December 31, 2012
Date:2/14/2013

is open and Janssen plans to enroll 110 patients worldwide.
  • Phase Ib/II dose escalating study of ibrutinib in combination with R-CHOP in patients with newly diagnosed CD20 positive non-Hodgkin's lymphoma. The purpose of this study is to identify a safe and tolerable dose of ibrutinib in combination with R-CHOP, once a safe dose is established the study will expand and report responses of this combination in patients with newly diagnosed DLBCL. This global, multi-center study, conducted by Janssen, is open and Janssen plans to enroll 33 patients.
  • Phase II study of ibrutinib in subjects with relapsed or refractory multiple myeloma (MM): This is a Phase II, multi-center, open-label trial designed trial to assess the safety and efficacy of ibrutinib single agent and in combination with dexamethasone in subjects with relapsed or relapsed MM. This study is conducted by Pharmacyclics and is currently exploring ibrutinib administration at 560 mg in combination with dexamethasone. Two further cohorts are planned to be explored; 840 mg with dexamethasone and 840 mg as a single agent. The Company anticipates an update on this study will be provided by year end 2013.
  • Phase II open-label, multicenter, single-arm study of monotherapy ibrutinib in subjects with relapsed or refractory follicular lymphoma. The primary endpoint of this study is objective response rate. Janssen plans to enroll 110 patients in this study.

    • PCYC has received Orphan Drug and Fast Track designation for ibrutinib treatment of chronic lymphocytic leukemia last year. The FDA has also granted Orphan Drug and Fast Track designation most recently to ibrutinib for the treatment of mantle cell lymphoma.  A US orphan drug designation provides the drug developer with several benefits and incentives related to the orphan drug, including a 7-year period of U.S. marketing exclusivity if the drug is the first of its type approved for the specified indication. Fast tra
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    SOURCE Pharmacyclics, Inc.
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