Cell Therapeutics Reports New Data Demonstrating That Complete Responses to Pixuvri Are Correlated With Prolonged Survival in Patients With Relapsed or Refractory Aggressive NHL
Exploratory Analysis from Pivotal Trial Presented at Advisory Panel during the 15th Congress of the European Hematology Association
SEATTLE, June 11 /PRNewswire-FirstCall/ -- Cell Therapeutics,
Inc. (the "Company") (Nasdaq and MTA: CTIC) today reported
exploratory analyses of the data at study completion from the
Company's pivotal PIX301 trial of Pixuvri(TM) (pixantrone
dimaleate), the first randomized controlled trial in patients with
relapsed or refractory, aggressive non-Hodgkin's lymphoma ("NHL").
These analyses demonstrated that patients who achieved a complete
response (CR)/unconfirmed complete response (CRu) to Pixuvri had up
to a 63% probability of being alive at 24 months compared to a 20%
probability for patients treated with comparator agents. The study
showed a 21% improvement in overall survival for all patients who
received Pixuvri that was independent of factors known to influence
survival like prior rituximab use, international prognostic index
(IPI) score, prior stem cell transplant, baseline level of LDH
(lactate dehydrogenase), or refractory status based on univariate
Cox regression analyses of survival. These data were presented at a
Company-sponsored lymphoma expert panel during the 15th Congress of
the European Hematology Association.
"The overall strength of evidence, including the significant
increases observed in clinically-important parameters like overall
response rates (ORR) and progression free survival (PFS), provides
important support to the clinical benefit of Pixuvri compared to
current single-agent treatment in a setting where there are no
approved or consensus therapies for relapsed or refractory
aggressive NHL," said Dr. Andreas Engert, University Hospital of
Cologne. "The updated end-of-study survival data demonstrates a
lasting benefit of achieving a CR/CRu with Pixuvri, with 8 of the
12 patients known alive at end of study having achieved a CR/CRu.
It is particularly notable that overall survival was not influenced
by important risk factors, and also that 76% of the patients who
achieved a CR/CRu with Pixuvri failed to respond to or had a lesser
response to their last multi-agent therapy. I look forward to
working with the Company as it prepares for submission of its
Marketing Authorization Application ("MAA") for Pixuvri to the
European Medicines Agency ("EMEA")."
About Pixantrone
Pixantrone is a novel aza-anthracenedione that has distinct
structural and physio-chemical properties that make its anti-tumor
activity unique in this class of agents. Similar to anthracyclines,
pixantrone inhibits Topo-isomerase II but unlike
anthracyclines--rather than intercalation with DNA--pixantrone
alkylates DNA--forming stable DNA adducts, with particular
specificity for CpG rich, hyper-methylated sites. These structural
differences resulted in significantly enhanced anti-lymphoma
activity compared to doxorubicin in preclinical models. In
addition, the structural motifs on anthracycline-like agents that
are responsible for the generation of oxygen free radicals and the
formation of toxic drug-metal complexes have also been modified in
pixantrone to prevent the binding of iron and perpetuation of
superoxide production--both of which are the putative mechanism for
anthracycline induced acute cardiotoxicity. These novel
pharmacologic differences may allow re-introduction of
anthracycline like potency in the treatment of relapsed/refractory
aggressive lymphoma without unacceptable rates of
cardiotoxicity.
About PIX301 (EXTEND) Clinical Trial
Pixantrone was studied in the Company's EXTEND, or PIX301,
clinical trial, which was a phase III single-agent trial of
pixantrone for patients with relapsed refractory aggressive NHL who
received two or more prior therapies and who were sensitive to
treatment with anthracyclines The results of the EXTEND trial
showed that patients randomized to treatment with pixantrone
achieved a significantly higher rate of confirmed and unconfirmed
complete remissions compared to patients treated with standard
chemotherapy, had a significantly increased overall response rate
and experienced a statistically significant improvement in median
progression free survival. Pixantrone was safely administered at
the proposed dose and schedule in the PIX301 clinical trial in
heavily pre-treated patients. The most common (incidence greater
than or equal to 10%) grade 3/4 adverse events reported for
pixantrone-treated subjects across studies were neutropenia and
leukopenia. Use of growth factor support was minimal. Other common
adverse events (any grade) included infection, anemia, leukopenia,
thrombocytopenia, asthenia, pyrexia and cough. Overall, the
incidence of grade 3 or greater cardiac adverse events was 7% (5
patients) on the pixantrone arm and 2% (1 patient) on the
comparator arm. There were an equal number of deaths due to an
adverse event in both the pixantrone and comparator arm.
About Cell Therapeutics, Inc.
Headquartered in Seattle, the Company 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.CellTherapeutics.com.
Sign up for email alerts and get RSS feeds at our Web site,
http://www.celltherapeutics.com/investors_alert
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 and
the trading price of the Company's securities. 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 the
treatment of relapsed or refractory, aggressive NHL as determined
by the EMEA, that the Company may not submit its MAA to the EMEA,
that there may not be a correlation between CR/CRu's and
progression free survival, that pixantrone may not show an overall
improvement rate in survival for patients independent of factors
known to influence survival, 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, 10-Q and 8-K. Except as may be
required by law, the Company does not intend to update or alter its
forward-looking statements whether as a result of new information,
future events, or otherwise.
Media Contact: Dan Eramian T: 206.272.4343 C: 206.854.1200 E: deramian@ctiseattle.com www.CellTherapeutics.com/press_room Investors Contact: Ed Bell T: 206.282.7100 Lindsey Jesch Logan T: 206.272.4347 F: 206.272.4434 E: invest@ctiseattle.com www.CellTherapeutics.com/investors Medical Information Contact: T: 800.715.0944 E: info@askarm.com
Source: Cell Therapeutics, Inc.
CONTACT: Media, Dan Eramian, +1-206-272-4343, cell,
+1-206-854-1200,
deramian@ctiseattle.com, or
investors, Ed Bell, +1-206-282-7100, or Lindsey
Jesch Logan, +1-206-272-4347, fax, +1-206-272-4434, invest@ctiseattle.com, all
of Cell Therapeutics, Inc.; or Medical Information,
1-800-715-0944,
info@askarm.com
Web Site: http://www.celltherapeutics.com/
Posted: June 2010
