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Pharmacyclics Reports Financial Results for Fiscal 2010 and for Fourth Quarter 2010
Date:9/13/2010

ratory and clinical members of the CLL and lymphoma program at OSU are very excited to be involved with the pre-clinical and clinical development of PCI32765."

Recent and Upcoming Milestones and Program Updates

  • Bruton's Tyrosine Kinase (Btk) Inhibitor, PCI-32765, results from first in human phase I trial were presented at an oral presentation at the American Society of Clinical Oncology (ASCO) annual meeting that took place in Chicago, Illinois in June 2010. These results were also presented at the European Hematology Association in Barcelona, Spain in June 2010. The presentations reported data from the ongoing open-label, dose-escalation study of PCI-32765 in recurrent B cell malignancies.
  • Trial Results as of August 31, 2010: In the first 6 dose cohorts, a total of 47 relapsed/refractory and progressing patients with a variety of B cell malignancies were enrolled. Forty-one of the enrolled patients had an on-treatment tumor assessment of therapy and are evaluable as of August 31, 2010. Twenty-one of these evaluable patients had a complete or partial response as their best response and eleven patients had stable diseases. This equates to a response rate of 51% in the evaluable patients (69% in CLL, 75% in Mantle, 42% in Follicular, 33% in Marginal and 38% in DLBCL). On an intent-to-treat ("ITT") basis the overall response rate ("ORR") was 45%.

  • NComplete ResponsePartial ResponseStable DiseaseProgressive DiseaseNot Evaluable*Evaluable RR %ORR %
    ITT**Chronic/Small  Lymphocytic Leukemia (CLL/SLL)15

    1

    8

    4

    0

    2

    69%
    (9/13)

    60%
    (9/15)Mantle Cell (MCL)4

    2

    1

    1

    075%
    (3/4)

    75%
    (3/4)Diffuse Large B Cell Lymphoma (DLBCL)83

    1

    438%
    (3/8)

    38%
    (3/8)Follicular Lymphoma (FL)15

    1

    4

    3

    4

    3

    42%
    (5/12)

    33%
    (5/15)Margi
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    SOURCE Pharmacyclics
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