Cell Therapeutics, Inc.
(CTI) (Nasdaq and MTA: CTIC) announced that it achieved the primary
efficacy endpoint of its phase III EXTEND (PIX301) trial of pixantrone
(BBR2778) for patients with advanced, relapsed aggressive non-Hodgkin's
lymphoma (NHL) based on a preliminary intent to treat efficacy analysis.
Patients randomized to treatment with pixantrone achieved a high rate of
confirmed and unconfirmed complete remissions compared to patients treated
with standard chemotherapy (14/70 (20.0%) for pixantrone arm compared to
4/70 (5.7%) for the standard chemotherapy arm, p = 0.02). No patient (0%)
in the standard chemotherapy arm achieved a confirmed complete remission
compared to 8/70 (11%) of pixantrone recipients. Pixantrone treatment also
significantly increased the overall response rate (CR/uCR+PR) with (26/70
(37.1%) for pixantrone arm compared to 10/70 (14.3%) for the control arm, p
= 0.003). CR/uCR and ORR were determined by an independent assessment panel
that was blinded to the treatment assignments. The most common serious
toxicities (>5%) seen in previous trials of pixantrone include grade 3 and
4 neutropenia and febrile neutropenia. Complete safety information is not
yet available for the study, however, the study was monitored on an ongoing
basis by an independent Data Safety Monitoring Committee and no serious
concerns were raised. Seventy-four percent of patients discontinued therapy
for disease progression or death, the majority of which were in the
standard chemotherapy control arm.
CTI plans to submit complete study data for presentation at a major
scientific conference. CTI also intends to request a pre-NDA meeting with
the FDA and expects to begin submission of a rolling New Drug Application
(NDA) to the FDA in early 2009.
"This positive phase III study is validation of Cell Therapeutics
Inc.'s capabilities in acquiring attractive drug candidates, and designing
and implementing a successful phase III trial," said James A. Bianco, M.D.,
CEO of Cell Therapeutics. "These data are consistent with the extensive
experience with pixantrone in our phase I and phase II studies and
demonstrate the ability to offer patients with advanced, relapsed NHL the
potential to obtain a clinically meaningful response like a complete
remission, despite having failed multiple other courses of chemotherapy or
immuno-chemotherapy."
The EXTEND clinical trial is a phase III single-agent trial of
pixantrone for patients with relapsed, aggressive non-Hodgkin's lymphoma
who received two or more prior therapies and who were sensitive to
treatment with anthracyclines. The trial was conducted at 130 sites in 17
countries. The trial enrolled 140 patients and patients were randomized to
receive either pixantrone or another single-agent drug currently used for
the treatment of this patient population and selected by the physician. The
trial was designed to examine the complete remission (CR) or unconfirmed
complete remission (uCR) rate, overall survival (OS) and progression-free
survival (PFS). The study received Special Protocol Assessment approval
from the U.S. Food and Drug Administration (FDA) in 2004 and pixantrone has
received fast track designation for this indication.
CTI intends to further evaluate additional details of the study and
will provide complete safety and progression-free survival information
comparing treatment assignments which is currently being assembled for
analysis.
About Pixantrone
Pixantrone (BBR 2778), a DNA intercalating antitumor agent that
contains an aza-anthracenedione molecular structure, differentiating it
from anthracycline chemotherapy agents, was discovered by our scientists in
Bresso, Italy. Pixantrone is a novel DNA major groove binder that contains
an aza-anthracenedione molecular structure, differentiating it from
anthracycline chemotherapy agents. Anthracyclines have been shown to be
very active clinically in a number of tumor types, such as lymphoma,
leukemia, and breast cancer. For these diseases, anthracycline-containing
chemotherapy regimens are effective in first-line (initial) treatment.
However, they may cause cumulative heart damage that limits lifetime dosage
and does not allow for retreatment. Pixantrone has been designed to reduce
the potential for heart damage compared to currently available
anthracyclines or anthracenediones without a loss in anti-tumor or
immunomodulatory activities.
About Non Hodgkin's Lymphoma
Non-Hodgkin's lymphoma (NHL) is caused by the abnormal proliferation of
white blood cells and normally spreads through the lymphatic system, a
system of vessels that drains fluid from the body. NHL can be broadly
classified into two main forms -- aggressive NHL, a rapidly spreading acute
form of the disease, and indolent NHL, which progresses more slowly.
According to the National Cancer Institute's SEER database there were
nearly 400,000 people in the U.S. with NHL in 2004. The American Cancer
Society estimates that in the United States 66,120 people are expected to
be diagnosed with NHL in 2008. Additionally, approximately 19,160 are
expected to die from this disease in 2008.
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
celltherapeutics.
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 results of complete safety and
progression free survival information for pixantrone which is still being
assembled, the potential failure of pixantrone to prove safe and effective
for treatment of relapsed aggressive NHL as determined by the FDA,
determination the FDA that the PIX301 trial is insufficient to support an
NDA filing, the Company's ability to continue to raise capital as needed to
fund its operations, 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 law, CTI does not intend to update or alter its
forward-looking statements whether as a result of new information, future
events, or otherwise.
Cell Therapeutics, Inc.
celltherapeutics