Pharmacyclics,
Inc. (Nasdaq: PCYC) today announced that it has submitted a New Drug
Application (NDA) for Xcytrin(R) (motexafin gadolinium) Injection with the
U.S. Food and Drug Administration (FDA). The company is seeking approval to
market Xcytrin for the treatment of non-small cell lung cancer (NSCLC)
patients with brain metastases (i.e., cancer that has spread to the brain
from another part of the body).
The NDA data packet includes efficacy and tolerability data from two
Phase 3 randomized, controlled trials involving 805 patients, which
compared the safety and efficacy of whole brain radiation therapy (WBRT)
alone to WBRT plus Xcytrin. These studies utilized an innovative clinical
benefit endpoint that measured neurologic outcomes.
"The clinical development program with Xcytrin continues on multiple
fronts," said Richard A. Miller, M.D., president and CEO of Pharmacyclics.
"In addition to the completed trials in brain metastases, which form the
basis of our NDA submission, several other ongoing trials are evaluating
Xcytrin in non-small cell lung cancer and other cancers. We are also moving
forward with several other novel compounds, which are in clinical and
preclinical development."
About Lung Cancer and Brain Metastases
According to the National Cancer Institute, over 170,000 patients will
be diagnosed with lung cancer this year in the U.S. Lung cancer is the most
common cause of brain metastases, which are estimated to occur in up to 50%
of lung cancer patients. Spread of lung cancer to the brain may occur early
in the course of disease or may be a later complication of this illness.
Brain metastases occur when cancer cells spread to the brain and grow,
causing major neurologic complications. Patients with brain metastases
usually suffer serious deterioration of neurologic and neurocognitive
function such as loss of short-term memory, compromised verbal skills and
fine motor coordination, and reduction in cognitive performance. Standard
therapy for patients with brain metastases from lung cancer involves the
prompt use of cranial radiation, which is used to prevent neurological
deterioration and improve neurologic outcomes.
About Xcytrin
Pharmacyclics is developing Xcytrin as an anti-cancer agent with a
novel mechanism of action that is designed to selectively concentrate in
tumors and induce apoptosis (programmed cell death). Xcytrin is a
redox-active drug that has been shown to disrupt redox-dependent pathways
in cells and inhibit oxidative stress related proteins. Its multifunctional
mode of action provides the opportunity for Xcytrin to be used in a broad
range of cancers. Xcytrin has been granted Fast Track designation by the
FDA for use in the treatment of lung cancer brain metastases. This
designation is reserved for new drugs that demonstrate the potential to
address an unmet medical need and are intended for the treatment of a
serious or life-threatening condition.
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. Its lead product, Xcytrin(R), has completed Phase
3 clinical trials and several ongoing Phase 1 and Phase 2 clinical trials
are evaluating Xcytrin as a single agent or in combination with
chemotherapy and/or radiation in multiple cancer types. More information
about the company, its technology, and products can be found at
pharmacyclics. Pharmacyclics(R), Xcytrin(R) and the "pentadentate"
logo(R) are registered trademarks of Pharmacyclics, Inc.
Other than statements of historical fact, the statements made in
this press release about enrollment and future plans for our clinical
trials, progress of and reports of results from preclinical and clinical
studies, clinical development plans and product development activities are
forward- looking statements, as defined in the Private Securities
Litigation Reform Act of 1995. The words "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 the
possibility that the FDA refuses to accept or approve any NDA we submit;
because our Phase 3 clinical trial known as the SMART (Study of Neurologic
Progression with Motexafin Gadolinium and Radiation Therapy) trial failed
to meet its primary endpoint, the FDA may require additional data, analysis
or studies before the NDA is accepted for filing or approved by the FDA;
the outcome of any discussions with the FDA; the initiation, timing,
design, enrollment and cost of clinical trials; unexpected delays in
clinical trials and preparation of materials for submission to the FDA as
part of our NDA filing; 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 obtain future financing and
fund the preparation of our NDA filing and the product development of our
pipeline; 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, 2006. 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.
pharmacyclics