Cell Therapeutics, Inc.
(CTI) (Nasdaq and MTAX: CTIC) today announced it has filed for a Special
Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA)
for the design of its phase III trial of pixantrone for patients with
indolent non- Hodgkin's lymphoma (NHL). The trial, PIX303, will examine the
complete remission rates and time to disease progression of the combination
regimen of fludarabine, pixantrone and rituximab (FP-R) compared to the
combination of fludarabine and rituximab (F-R) in the treatment of patients
who have failed up to five prior treatments for relapsed or refractory
indolent NHL. The trial is expected to enroll 300 patients.
"The impressive complete remission rates and durable survival data in
our phase II combination study for indolent NHL patients provides the
rationale for conducting a phase III study and we look forward to feedback
and guidance from the FDA on the study design," said James A. Bianco, M.D.,
President and CEO of CTI. "Pixantrone has shown encouraging activity in
both indolent and aggressive NHL especially in the relapsed setting, paving
a route for a potential registration across both types of NHL thus
potentially doubling the size of the market potential in lymphoma."
About Pixantrone
Pixantrone is an investigational agent under development for the
potential treatment of various hematological malignancies, solid tumors and
immunological disorders. It was developed to improve the activity and
safety of the anthracycline family of anti-cancer agents. Anthracyclines
have been shown to be very active clinically in a number of tumor types.
However, they are usually associated with cumulative heart damage that
prevents them from being used in a large proportion of patients. Pixantrone
has been designed to reduce the potential for these severe
cardiotoxicities, as well as to potentially increase activity and
simplified administration compared to the currently marketed
anthracyclines.
Pixantrone in Indolent NHL
Preliminary results from a phase I/II study of pixantrone combined with
fludarabine, dexamethasone, and rituximab for patients with relapsed
indolent NHL were presented at the American Society of Hematology (ASH)
annual meeting in December, 2006. Among the 27 patients evaluable for
response, study results showed the FPD-R regimen with pixantrone produced
an 89 percent overall response rate (ORR) by the Cheson criteria, including
70 percent of patients experiencing a complete response/unconfirmed
complete response (CR/uCR; 63 percent, CR and seven percent, u/CR). The
estimated median duration of response was 25 months and the estimated
progression-free survival rate at three years was 50.4 percent. In
addition, pixantrone was studied in a randomized clinical trial for
indolent NHL patients comparing pixantrone in combination with rituximab to
rituximab alone, with time to progression (TTP) as the primary efficacy
endpoint. The study of 38 relapsed or refractory patients receiving the
combination of rituximab and pixantrone had an 87 percent overall
improvement in TTP compared to rituximab alone. The median TTP estimate for
the pixantrone/rituximab recipients was 13.2 months compared to 8.1 months
for rituximab alone (hazard ratio 0.13, log rank p
Pixantrone in Aggressive NHL
Pixantrone has been studied extensively in aggressive NHL patients,
including two ongoing studies, a phase III single agent trial, known as
EXTEND and a phase II combination study, known as RAPID. The EXTEND trial
explores the role of single agent treatment as a salvage regimen in
patients with relapsed aggressive NHL who have failed at least two prior
treatment regimens.
Patients are randomized to receive either pixantrone or another
single-agent drug of physician's choice currently used for the treatment of
this patient population. An interim look is planned for the summer of 2007.
The RAPID trial is a first-line phase II study in aggressive NHL
patients that will evaluate pixantrone as part of the CPOP-R combination
regimen (cyclophosphpamide, pixantrone, vincristine, prednisone and
rituximab) compared to the standard treatment regimen, CHOP-R
(cyclophosphpamide, doxorubicin, vincristine, prednisone and rituximab).
This study will explore the potential cardiac safety benefits of pixantrone
in chemotherapy na??ve patients when compared directly to doxorubicin.
About NHL
According to the SEER CanQuest Database and the American Cancer
Society, in 2005 the prevalence of aggressive NHL in the U.S. was 99,880
with 31,900 newly diagnosed patients. The prevalence of indolent NHL in the
U.S. was 282,025 with 24,490 newly diagnosed patients.
About Cell Therapeutics, Inc.
Headquartered 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
cticseattle.
This press release 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 pixantrone include risks
associated with preclinical and clinical developments in the
biopharmaceutical industry in general and with pixantrone in particular
including, without limitation, the potential failure of pixantrone to prove
safe and effective for treatment of non-Hodgkin's lymphoma, determinations
by regulatory, patent and administrative governmental authorities,
competitive factors, technological developments, costs of developing,
producing and selling pixantrone, 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. Except as may be required by Italian law, CTI
is under no obligation to (and expressly disclaims any such obligation to)
update or alter its forward- looking statements whether as a result of new
information, future events, or otherwise.
Cell Therapeutics, Inc.
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