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Pharmacyclics Reports Recent Developments From Clinical Studies of its Btk Inhibitor PCI-32765
Date:6/6/2011

ypes of DLBCL, the activated B-cell (ABC) subtype and the germinal center (GC) subtype. We have enrolled 3 out of the planned 60 patients and expect to complete enrollment in the first quarter of calendar 2012. Other trials evaluating the combination of PCI-32765 with chemotherapy in DLBCL are under development.

A separate pilot study of PCI-32765 in patients with ABC subtype DLBCL is currently being conducted at the NIH Clinical Center. Thus far, 8 out of a planned 10 patients have been enrolled. While it is too early to report full results of this study, objective responses, including complete responses, have been observed. We anticipate that this study once completed will be submitted for presentation at the 2011 American Society of Hematology Meeting

-- Follicular Lymphoma (FL)
Updated results from the Phase IA study have shown an improvement in the objective response rate in follicular lymphoma. We are encouraged by this preliminary signal and are developing a Phase II program in this histology. We anticipate the initiation of a Phase II trial in follicular lymphoma in the first half of 2012.

-- Multiple Myeloma (MM)
Ongoing pre-clinical studies, both internally as well as through external collaborations, have suggested a vital role for Btk in both malignant plasma cells and osteoclasts, which are involved in the bone complications of this disease. Therefore, we believe that Btk represents a viable therapeutic target in MM, and we are developing a Phase II trial of PCI-32765 in MM, which we expect to initiate in early 2012.

"In February 2009 Pharmacyclics dosed the first patient with PCI-32765, a Bruton tyrosine kinase irreversible inhibitor. Bottom line, we have now dosed 230 patients across multiple hematologic histologies. The results have exceeded the expectations of most all involved to this point in time. We look forward to continued progress as well as playing a meaningful role in the comin
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SOURCE Pharmacyclics, Inc.
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