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Pharmacyclics Reports Recent Developments and Financial Results for Fiscal Second Quarter 2011
Date:2/4/2011

SUNNYVALE, Calif., Feb. 4, 2011 /PRNewswire/ -- Pharmacyclics, Inc. (Nasdaq: PCYC) today reported recent developments and financial results for its fiscal second quarter that ended December 31, 2010.Recent Developments & Highlights

  • Broad Clinical Development Progress for Btk Inhibitor PCI-32765 in B-cell malignanciesPharmacyclics has designed a broad Phase II Program in mantle cell lymphoma, chronic lymphocytic leukemia and diffuse large B-cell lymphoma to inform the Phase III program and regulatory path for PCI-32765. Throughout 2011 we will closely monitor these Phase II studies for confirmatory efficacy and safety signals to establish our regulatory approval strategy in a timely manner.  Please refer to our website on the key trials listed below.-Mantle Cell Lymphoma (MCL) Our Phase IA results in the MCL subset presented at the 2010 American Society of Hematology (ASH) Meeting showed promising activity. We therefore designed a Phase II program which includes 1) an evaluation of PCI-32765 as a single agent in 2 groups (cohorts) of patients with relapsed or refractory disease, those who have failed bortezomib and those who have not yet received bortezomib and 2) a safety study of PCI-32765 in combination with bortezomib. The single agent trial protocol has been developed and we expect to enroll a total of approximately 100 patients, beginning in Q1 of calendar year 2011.-Chronic Lymphocytic Leukemia/Small Cell Lymphocytic Lymphoma (CLL/SLL) The Phase IB/II CLL/SLL program is well underway; to date we have dosed 75 patients and plan to complete enrollment by adding another 7 patients during the remainder of Q1 of calendar 2011. We are also evaluating the safety of PCI-32765 in combination with ofatumumab in a Phase IB/II study of patients with relapsed/refractory CLL/SLL. We began enrollment in this study in January of 2011 and expect to dose up
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