orally available, selective inhibitor of Bruton's tyrosine kinase,
or Btk, in collagen induced arthritis, an established animal model
for rheumatoid arthritis (RA). Treatment of animals with advanced
disease, with PCI-32765 reduced inflammation and induced regression
* Filed an investigational new drug (IND) application for PCI-27483, a
small molecule inhibitor of Factor VIIa being developed both for the
treatment of thrombotic complications of cancer and as an
* Plan to complete enrollment and evaluation of a Phase 1 trial in
normal volunteers with our Factor VIIa inhibitor, PCI-27483, in the
fourth quarter of calendar 2008.
* Plan to initiate a Phase 1 trial with our oral Btk inhibitor,
PCI-32765, in patients with recurrent B-cell lymphoma in the fourth
quarter of calendar 2008. This study is designed to evaluate safety
and efficacy using a novel pharmacodynamic biomarker.
* Plans are underway to design and conduct a pivotal Phase 3 trial
with motexafin gadolinium in patients with brain metastases from
non-small cell lung cancer receiving whole brain radiation and
stereotactic radiosurgery. This trial is anticipated to begin in the
first half of calendar 2009.
Conference Call and Webcast Details
The Company will hold a conference call today at 4:30 p.m. EDT to
discuss fiscal 2008 year-end financial results and achievements and fiscal
2009 guidance. To participate in the conference call, please dial
800-497-0451 for domestic callers and 706-758-3306 for international
callers and reference conference passcode 59146626. To access the live
audio broadcast or the subsequent archived recording, log on to
|SOURCE Pharmacyclics, Inc.|
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