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Pharmacyclics, Inc. Announces Presentation of Interim Results From Phase I Trial of Its First-In-Human Btk Inhibitor PCI-32765
Date:12/7/2009

NEW ORLEANS and SUNNYVALE, Calif., Dec. 7 /PRNewswire-FirstCall/ -- Pharmacyclics, Inc. (Nasdaq: PCYC) today announced interim data from a Phase I study of their novel orally administered Bruton's tyrosine kinase (Btk) inhibitor PCI-32765 in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL) or chronic lymphocytic leukemia (CLL). These data are being presented at the American Society of Hematology (ASH) 51st Annual Meeting taking place this week in New Orleans, LA.

The multi-center dose escalation Phase I study is being conducted in collaboration with investigators at leading lymphoma centers including Stanford University, MD Anderson Cancer Center, the University of Chicago, the University of Vermont, and US Oncology group. The trial was designed to explore up to 6 dose levels with a minimum of 4 evaluable patients per cohort. Each cycle of treatment consists of 28 consecutive days of dosing followed by 7 days of rest. Safety is evaluated at the end of the first cycle and efficacy at the end of the second. At least one full cycle of treatment has been completed for each patient in the first 3 cohorts. Data from the second cohort demonstrated that PCI-32765 fully occupied the active site of the target enzyme Btk in peripheral blood cells with minimal variability, fully inhibited surrogate biomarkers for up to 24 hours, and was well tolerated by patients.

In the first 2 dose cohorts, 16 heavily pretreated and progressing lymphoma patients with a variety of B-cell malignancies were evaluated. In the first dose cohort, 7 patients were treated with PCI-32765 resulting in 2 partial responses (e.g. a 50% decrease in sum of the product of the diameters of up to 6 largest dominant masses; no increase in size of other nodes per the Revised Response Criteria for Malignant Lymphoma Bruce D. Cheson J Clin
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