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Pharmacyclics Reports Financial Results and Recent Developments for Fiscal Year and Fourth Quarter 2011 - Conference Call Set for Today at 4:30 PM EDT
Date:9/12/2011

Treatment and Diagnosis plans to sponsor Phase I and Phase II trials of PCI-32765 in various hematologic malignancies.
  • The Phase II clinical program, designed to enable potential registrational paths in CLL, mantle cell lymphoma (MCL), and diffuse large B-cell lymphoma (DLBCL), is ongoing. We anticipate that these Phase II trials will allow for Phase III enabling decisions in these indications based upon ongoing analysis of the data in the next 6-12 months.

  • As of the end of August, 2011 we enrolled 320 patients into clinical trials evaluating PCI-32765. The ongoing Phase II program currently includes the following studies:
  • PCYC-1104:  A multicenter, Phase II study of PCI-32765 in relapsed or refractory mantle cell lymphoma, including cohorts of subjects either previously treated with bortezomib or naïve to bortezomib treatment. This trial is active in several US and European sites and by the end of August, 2011 enrolled 60 patients. We have submitted a preliminary analysis of this study for consideration for the 2011 ASH meeting in December, 2011.
  • PCYC-1106:  A multicenter, open-label, Phase II study of PCI 32765 in subjects with relapsed or refractory DLBCL. This study is designed to assess the activity of PCI-32765 in two genetically distinct subtypes of DLBCL, the activated B-cell (ABC) subtype and the germinal center (GC) subtype. This trial is active in several US sites and by the end of August, 2011 enrolled 13 patients. We expect to complete enrollment of all 60 patients by calendar Q1 2012. A separate pilot study of PCI-32765 in patients with ABC subtype DLBCL is currently being conducted at the NIH Clinical Center. An abstract detailing an interim analysis of this pilot trial has been submitted for consideration for the 2011 ASH meeting in December, 2011.
  • PCYC-1108: A Phase IB, multicenter, open-label, study of PCI 32765, in combination with intensive immune chemotherapy (FCR = fludarabine, cycl
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