SEATTLE, June 16 /PRNewswire-FirstCall/ --
Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC) received fast track designation
from the U.S. Food and Drug Administration (FDA) for XYOTAX(TM) (CT-2103), its
polyglutamate paclitaxel, for the treatment of advanced non-small cell lung
cancer (NSCLC) in patients with a poor performance status (PS2). Fast track
designation was granted because NSCLC in PS2 patients is incurable with
available therapy offering only modest benefit, and XYOTAX(TM) has the
potential to demonstrate improvement over available therapy in these patients
based on anticancer activity (tumor shrinkage) in phase I and II clinical
trials.
"We are extremely pleased that the FDA recognizes that this population of
patients has few viable treatment alternatives and that XYOTAX(TM) has the
potential to offer improvement over existing therapies," stated James A.
Bianco, M.D., President and CEO of CTI. "Fast track designation of XYOTAX(TM)
represents a major regulatory milestone in the development of this product
candidate."
XYOTAX(TM) is currently in two phase III clinical trials for PS2 patients
with advanced NSCLC. A new drug application for this indication is targeted
for the end of 2004. XYOTAX(TM) is also being studied in a phase III clinical
trial among patients with non-small cell lung cancer who have relapsed
following a single platinum-containing front-line treatment.
According to the American Cancer Society (www.cancer.org), approximately
172,000 new cases of lung cancer are expected during 2003. Non-small cell lung
cancer accounts for almost 80 percent of lung cancer cases and PS2 patients
make up roughly 20 to 30 percent of the newly diagnosed advanced NSCLC
patients.
Fast Track Designation
Fast track designation means the FDA will facilitate and expedite the
development and review of the application for the approval of a new drug if it
is intended for the treatment of a serious or life-threatening condition and
demonstrates the potential to address an unmet medical need. An expedited
review as defined by the FDA user fee performance goals provides for a review
within six months.
About XYOTAX(TM)
XYOTAX(TM) is a pharmaceutical that links paclitaxel, the active
ingredient in Taxol(R), to a biodegradable polyglutamate polymer. This polymer
technology results in a new chemical entity, designed to selectively deliver
higher and potentially more effective levels of active chemotherapeutics to
tumors. Blood vessels in tumor tissue, unlike blood vessels in normal tissue,
are porous to molecules like polyglutamate. Based on preclinical studies, it
appears that XYOTAX(TM) is preferentially trapped in the tumor blood vessels
allowing significantly more of the dose of chemotherapy to localize in the
tumor. Because more of the chemotherapy is targeted to the tumor and the
levels of chemotherapy delivered to normal tissue are reduced, XYOTAX(TM) may
be potentially more effective and have less severe side effects than currently
available chemotherapeutics.
About Cell Therapeutics, Inc.
Based in Seattle, CTI is a biopharmaceutical company committed to
developing an integrated portfolio of oncology products aimed at making cancer
more treatable. For additional information, please visit www.cticseattle.com.
This announcement includes forward-looking statements that involve a
number of risks and uncertainties, the outcome of which could materially
and/or adversely affect actual future results. Specifically, the risks and
uncertainties that could affect the development of XYOTAX(TM) include risks
associated with preclinical and clinical developments in the biopharmaceutical
industry in general and with XYOTAX(TM) in particular including, without
limitation, the potential failure of XYOTAX(TM) to prove safe and effective
for treatment of advanced non-small cell lung cancer, determinations by
regulatory, patent and administrative governmental authorities, including the
failure to receive approval of XYOTAX (TM) for treatment of advanced non-small
cell lung cancer, competitive factors, technological developments, costs of
developing, producing and selling XYOTAX(TM), and the risk factors listed or
described from time to time in the Company's filings with the Securities and
Exchange Commission including, without limitation, the Company's most recent
filings on Forms 10-K, 8-K and 10-Q.
