Pharmacyclics Reports CLL Results from Preclinical and Clinical Studies of its Btk Inhibitor PCI-32765

Sun, 12/05/2010 - 1:33pm

ORLANDO, Fla. and SUNNYVALE, Calif., Dec. 5, 2010 /PRNewswire-FirstCall/ -- Pharmacyclics, Inc. (Nasdaq: PCYC) today announced data from three Chronic Lymphocytic Leukemia (CLL) presentations at the American Society of Hematology (ASH) Annual Meeting describing the Btk-selective inhibitor PCI-32765.  Two presentations report preclinical data, and one presentation reports clinical data from a pooled analysis of 54 patients with CLL or Small Lymphocytic Lymphoma (SLL) treated with PCI-32765.

The two preclinical abstracts focus on the mechanism of action of this novel drug.  An oral presentation titled "Bruton's Tyrosine Kinase Inhibitor PCI-32765 Abrogates BCR and Nurselike Cell-Derived Activation of CLL Cells In Vitro and In Vivo" is being presented by Sabine Ponader, PhD from the MD Anderson Cancer Center.  The other preclinical presentation is a poster presented by Sarah Herman, PhD of the laboratory of John Byrd, MD, of The Ohio State University titled "The Kinase Inhibitor, PCI-32765, Demonstrates Activity in Chronic Lymphocytic Leukemia Cells Independent of Microenvironmental Survival Signals." Data from these two presentations together suggest a model whereby PCI-32765 directly affects CLL cells by inducing apoptosis, and also blocks the ability of CLL cells to migrate to and to adhere to lymph nodes, a protective environment where the tumors grow. The clinical results of treatment, as discussed below, appear to bear out these combined mechanisms, with evidence of impairment of both homing to lymph nodes and cell viability in the typical clinical response to PCI-32765.

Data Results from the Pooled Phase IA and IB Studies in CLL/SLLThe oral presentation, titled "The Bruton's Tyrosine Kinase Inhibitor PCI-32765 is Well Tolerated and Demonstrates Promising Clinical Activity In Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphom





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