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

Recent Developments & HighlightsTwo New England Journal of Medicine Publications
In June 2013, The New England Journal of Medicine (NEJM) published results from two Phase II studies of ibrutinib:  PCYC 1104-CA, a Phase II study evaluating  the safety and efficacy of ibrutinib monotherapy in patients with relapsed/refractory MCL; and PCYC 1102-CA, a Phase Ib/II study examining the safety and efficacy of ibrutinib monotherapy for the treatment of patients with relapsed/refractory CLL/ SLL, some of whom had deletion of part of chromosome 17 (del 17p). These data suggested ibrutinib may be effective and generally well-tolerated in patients with relapsed/refractory MCL and in patients with relapsed/refractory CLL/SLL. Both studies were originally presented at the annual meeting of the American Society of Hematology (ASH) in December 2012. Updated results from PCYC 1104-CA were presented at the European Hematology Association (EHA) Annual Meeting in June 2013.

Conferences and Presentations in June 2013
In June, Pharmacyclics and its collaborators presented 5 oral and 6 poster presentations on ibrutinib at three annual conferences: American Society of Clinical Oncology (ASCO), EHA, and the International Conference on Malignant Lymphoma (ICML).  These conferences showcased updated and expanded data in high risk CLL, relapsed or refractory MCL, and relapsed or refractory diffuse large B-cell lymphoma (DLBCL).  Also at these conferences ibrutinib data in two new areas were presented: Waldenstrom's Macroglobulinemia (WM) and frontline DLBCL in combination with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone). All oral presentations made at these conferences have been filed in Form 8-K's with the SEC.

Selected Clinical Trials Initiated with Ibrutinib Over the Last 18 MonthsCLL/SLL

  • RESONATE™ (PCYC-1112) Phase III study of ibrutinib versus ofatumumab in patients wi
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  • SOURCE Pharmacyclics, Inc.
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