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Pharmacyclics Reports Recent Developments and Financial Results for Fiscal Second Quarter 2011

to 40 patients and complete enrollment in the second half of calendar year 2011. We also plan to evaluate the safety of PCI-32765 in combination with several other common therapies in CLL and expect to begin enrollment in Q2 of calendar year 2011.-Diffuse Large B-Cell Lymphoma (DLBCL) Research has demonstrated that there are 2 distinct molecular subtypes in diffuse large B-cell lymphoma (ABC and GCB).  Activated B-cell, or ABC, is the poorer prognostic subtype and is characterized by activation of the B-cell receptor signaling pathway. Our Phase II program will evaluate 2 separate cohorts of patients with relapsed or refractory DLBCL who will receive single agent PCI-32765, those lymphoma patients with ABC and those with germinal center B-cell (GCB), the other molecular subtype. This study will evaluate safety and efficacy in approximately 60 patients. We anticipate that enrollment will begin during the first half of 2011. In parallel, we are also developing a Phase II safety trial combining PCI-32765 with chemotherapy in patients with relapsed or refractory DLBCL.

  • Abstract submitted to the 47th Annual Meeting of the American Society of Clinical Oncology (June 3 – 7, 2011) based on the Phase IB/II study data, evaluating safety and efficacy of administering the Btk Inhibitor, PCI-32765 as a single agent in CLL/SLL patients

  • Poster presentation at the 2011 GI Cancers Symposium of first in human Phase I results of Factor VIIa Inhibitor, PCI-27483 In the Phase I portion of the study, ascending repeated doses of PCI-27483 (dosages ranging from 0.8 to 1.5 mg/kg) were evaluated in 8 patients with pancreatic cancer receiving concomitant gemcitabine chemotherapy. Among the 5 patients in Phase I considered evaluable, all 5 had stable disease at week 12 and opted to extend treatment with PCI-27483. Three of the 5 patients have a progression free survival > / = 30 weeks (7 months). None

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