Pharmacyclics Initiates Phase 1 Clinical Trial of Novel Oral Btk Inhibitor for Refractory B-cell Non-Hodgkin'...(linical efficacywith PCI-32765 in these ...),Health

"Despite recent success with biologics in the treatment of B-cell NHL, there is still a large group of patients that do not respond to therapy or who experience recurrence," said Ranjana Advani, MD, Associate Professor, Stanford University Medical Center and principle investigator of the Phase 1 clinical trial. "A drug that could not only have an impact on this patient group, but also be delivered orally would represent a significant step forward in the treatment of this disease."

This Phase 1 study is evaluating the safety and pharmacokinetics of PCI-32765 in patients with refractory B-cell non-Hodgkin's lymphoma at Stanford University, MD Anderson Cancer Center and the University of Chicago using a 28-day dose-escalation design. The study is also utilizing a proprietary pharmacodynamic assay developed by Pharmacyclics to directly assess Btk drug occupancy. Preliminary results from the Phase I trial shows good patient tolerability under conditions of Btk-drug occupancy with potent bioactivity in targeted cell populations derived from the B-cell lymphoma patients.

Pharmacyclics Btk Presentations at AACR

Monday April 20, 2009

9:30 am - 1:00 pm; Minisymposium Novel Molecular Targets / Targeting Cell Death Pathways; Experimental and Molecular Therapeutics 12 Room 405-407, Colorado Convention Center 9:40am-9:55am

#1984 Btk is a Novel Therapeutic Target to Treat Large B-cell Lymphomas Ryan M. Young, Ashley Smith, Lee Honigberg, Yosef Refaeli. National Jewish Health, Denver, CO, Pharmacyclics, Inc., Sunnyvale, CA

Tuesday April 21, 2009