Pharmacyclics, Inc.
(Nasdaq: PCYC) announced results from a preclinical study evaluating
PCI-32765, an orally available, selective inhibitor of Bruton's tyrosine
kinase, or Btk, in collagen induced arthritis, an established animal model
for rheumatoid arthritis (RA). The data were presented during the
Federation of Clinical Immunology Societies (FOCIS) meeting being held this
week in Boston, MA.
Researchers examined the impact of treatment with PCI-32765 on mouse
models of rheumatoid arthritis at disease onset, and with established
active disease. Treatment prevented further joint swelling when animals
were dosed at early stages of disease. In animals with advanced disease,
treatment with PCI-32765 reduced inflammation and induced regression of
disease with approximately 50% reduction in histopathologic score after
only five days of dosing. Treatment with PCI-32765 was found to inhibit
mast cell function and to prevent allergic reaction, with passive cutaneous
analphylaxis inhibited by more than 95%. In other studies, human B-cell
activation was shown to be selectively inhibited by drug treatment in
vitro. PCI-32765 also inhibited the proliferation of, and induced apoptosis
in, multiple B-cell lymphoma cell lines in vitro, suggesting that Btk
inhibition could be a novel drug target in lymphoma.
"This study suggests that treatment with PCI-32765 causes a potent
combined blockade of both B-cell and mast cell activation," said Joseph J.
Buggy, Ph.D., vice president of research for Pharmacyclics. "This dual
blockade may account for the preclinical efficacy seen in established
arthritis models and holds promise for potential use in humans with
advanced RA and other immune mediated diseases. The inhibition of B-cell
function and proliferation in the various models, including lymphomas,
forms the basis for our phase 1 clinical trial, which is anticipated to
begin in the fourth quarter of calendar 2008."
Btk is a critical enzyme involved in B-cell activation and mast cell
function, and inhibition of its function may be useful in the treatment of
immune mediated diseases. Mast cells play a key role in the inflammatory
process and are implicated in the pathology associated with the autoimmune
disorders, such as RA and in allergy. Recently, mast cells have been found
to play an important role in tumor growth and angiogenesis. B-cells are a
type of white blood cell that normally play an important role in the body's
immune response. However, when B-cells are overactive, the immune system
produces inflammatory cells and antibodies that begin to attack the body's
own tissue, leading to autoimmune disorders. Most lymphomas are caused by
uncontrolled growth of B-cells where activation of the B-cell receptor and
Btk signaling are thought to play important roles.
About Pharmacyclics
Pharmacyclics is a pharmaceutical company developing innovative
products to treat cancer and other serious diseases. The company is
leveraging its small-molecule drug development expertise to build a
pipeline in oncology and other diseases based on a wide range of targets,
pathways and mechanisms. More information about the company, its
technology, and products can be found at pharmacyclics.
Pharmacyclics(R) and the "pentadentate" logo(R) are registered trademarks
of Pharmacyclics, Inc.
NOTE: Other than statements of historical fact, the statements made in
this press release about plans for initiating a Phase 1 study for
PCI-32765, and other future plans for our clinical trials, progress of and
reports of results from preclinical and clinical studies, clinical
development plans and product development and corporate partnering
activities are forward-looking statements, as defined in the Private
Securities Litigation Reform Act of 1995. The words "project," "believe,"
"will," "may," "continue," "plan," "expect," "intend," "anticipate,"
variations of such words, and similar expressions also identify
forward-looking statements, but their absence does not mean that the
statement is not forward-looking. The forward-looking statements are not
guarantees of future performance and are subject to risks and uncertainties
that may cause actual results to differ materially from those in the
forward-looking statements. Factors that could affect actual results
include risks associated with unexpected delays in clinical trials and
preclinical studies and the timing for making related regulatory filings;
the fact that data from preclinical studies and Phase 1 or Phase 2 clinical
trials may not necessarily be indicative of future clinical trial results;
our ability to estimate accurately the amount of cash to be used to fund
operations over the next 12 months, our ability to obtain future financing
and fund the product development of our pipeline; the initiation, timing,
design, enrollment and cost of clinical trials and preclinical studies; our
ability to establish successful partnerships and collaborations with third
parties; the regulatory approval process in the United States and other
countries; and our future capital requirements. For further information
about these risks and other factors that may affect the actual results
achieved by Pharmacyclics, please see the company's reports as filed with
the U.S. Securities and Exchange Commission from time to time, including
but not limited to its annual report on Form 10-K for the period ended June
30, 2007 and its subsequently filed quarterly reports on Form 10-Q.
Forward-looking statements contained in this announcement are made as of
this date, and we undertake no obligation to publicly update any
forward-looking statement, whether as a result of new information, future
events or otherwise.
Pharmacyclics, Inc.
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