Pharmacyclics, Inc.
(Nasdaq: PCYC) today announced that the company plans to submit a New Drug
Application (NDA) to the U.S. Food and Drug Administration (FDA) to market
Xcytrin(R) (motexafin gadolinium) Injection for the treatment of non-small
cell lung cancer (NSCLC) patients with brain metastases (i.e., lung cancer
that has spread to the brain from another part of the body).
The company also announced that new analyses and additional data from
its Phase 3 SMART (Study of Neurologic Progression with Motexafin
Gadolinium And Radiation Therapy) trial will be presented at the upcoming
Annual Meeting of the American Society of Clinical Oncology (ASCO) in
Atlanta. Details on the oral presentation are as follows:
Abstract #7014: "Motexafin gadolinium (MGd) combined with prompt whole
brain radiation therapy (RT) prolongs time to neurologic progression in
non-small cell lung cancer (NSCLC) patients with brain metastases: Results
of a Phase 3 trial," Minesh P. Mehta, M.D., Dept. of Human Oncology,
University of Wisconsin, Madison, Saturday, June 3, 2006, 5:30 - 5:45 p.m.
The presentation will be followed by a discussion by Laurie E. Gaspar,
M.D., Professor and Chair of Radiation Oncology at the University of
Colorado.
The SMART trial was conducted at 94 centers in North America, Europe
and Australia and enrolled 554 patients with brain metastases from NSCLC.
This randomized, controlled Phase 3 trial compared the safety and efficacy
of whole brain radiation therapy (WBRT) alone to WBRT plus Xcytrin. The
primary endpoint of the study was time to neurologic progression as
determined by a blinded events review committee.
"We plan to file an NDA for Xcytrin primarily based on the data frompharmacyclics
our pivotal SMART trial," said Richard A. Miller, M.D., president and CEO
of Pharmacyclics. "New data from the SMART trial, which will be included in
the NDA filing, will be presented and discussed at ASCO. We anticipate
filing the Xcytrin NDA by the end of 2006."
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 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, atherosclerosis 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, has completed
Phase 3 clinical testing in lung cancer brain metastases and several Phase
1 and Phase 2 clinical trials are ongoing with Xcytrin, either as a single
agent or in combination with chemotherapy and/or radiation in multiple
cancer types. Pharmacyclics has other product candidates in earlier-stage
development for cancer and inflammatory diseases. 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.
NOTE: 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, including results from our SMART trial, clinical development plans
and product development activities are forward-looking statements, as
defined in the Private Securities Litigation Reform Act of 1995. The words
"potential," "project," "believe," "will," "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 initiation, timing, design, enrollment
and cost of clinical trials; unexpected delays in and unanticipated
increases in costs related to our preclinical studies and clinical trials;
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 product development of
our pipeline; the outcome of our discussions with the FDA; our ability to
prepare and submit an NDA on a timely basis or at all; the possibility that
the FDA refuses to accept any NDA we submit; the possibility that
additional data or studies may be required before the NDA is accepted for
filing or approved by the FDA; our ability to establish successful
partnerships and collaborations with third parties; the regulatory approval
process in the United States and other countries; and 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 quarterly
report on Form 10-Q for the period ended December 31, 2005. 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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