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Data Presented at American Society of Hematology from Ibrutinib Phase 1b/2 and Phase 2 Trials Suggest High and Durable Response in Chronic Lymphocytic Leukemia
Date:12/8/2012

immunotherapy.

The results after a follow-up of three to six months are:

  • The ORR was 83 percent
  • 38 of 40 patients continue on therapy without disease progression
  • 95 percent of all patients and 90 percent of patients with del17p had not progressed
  • There was a large and rapid reduction in lymph node and spleen sizes, with 84 percent of patients (26/31) experiencing more than a 50 percent decrease in lymph node size
  • Treatment was well tolerated overall, with Grade 3 or Grade 4 toxicities infrequent and transient in nature, including febrile neutropenia (fever with low white blood cell count), anemia, mucositis and pneumonia, in this clinical study

"We believe the updated findings from these two trials further affirm the possibilities of ibrutinib," said Bob Duggan, CEO and Chairman of the Board of Directors of Pharmacyclics. "We look forward to continuing our clinical development program for this therapy, and hope it can help us in achieving Pharmacyclics' mission of improving the quality and duration of life for patients with oncologic diseases."

About Ibrutinib
Ibrutinib was designed to specifically target and selectively inhibit an enzyme called Bruton's tyrosine kinase (BTK). BTK is a key mediator of at least three critical B-cell pro-survival mechanisms occurring in parallel – regulating B-cell apoptosis, cell adhesion, and lymphocyte migration and homing. Data are consistent with a mechanistic model whereby ibrutinib blocks BCR signaling, which drives cells into apoptosis and/or disrupts cell migration and adherence to tumor-protective microenvironments.

The effectiveness of ibrutinib alone or in combination with other treatments is being studied in several B-cell malignancies, including CLL/SLL, relapsed/refractory mantle cell lymphoma, diffuse large B-cell lymphoma, follicular lymphoma and multiple myeloma. A comprehensive late stage P
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SOURCE Pharmacyclics, Inc.
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