Low Occurrence of Severe Cardiac Side Effects Despite Extensive Prior Doxorubicin...
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Low Occurrence of Severe Cardiac Side Effects Despite Extensive Prior
Doxorubicin Treatment Reported in Pixantrone Pivotal Trial
Updated Safety data presented at BIO International Convention in Atlanta
ATLANTA, May 19 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI)
(Nasdaq and MTA: CTIC) released updated safety data today from its pixantrone
phase III 301 EXTEND trial demonstrating the effectiveness of pixantrone in
patients with relapsed/refractory aggressive non-Hodgkin's lymphoma (NHL) for
whom anthracycline-related drugs are typically not to be used due to the
increased risk of cardiac failure.
As noted during the presentation of Craig Philips, President of CTI, "The
standard chemotherapy regimen (CHOP) for this disease exposes patients to less
than or equal to 300mg/m2 of doxorubicin, a dose at which 5.6% of patients are
expected to develop congestive heart failure (CHF). At cumulative doses of
doxorubicin in excess of 600mg/m2, 48% of patients develop CHF."
"With these background statistics, we examined the occurrence of CHF from any
cause among PIX 301 recipients who received prior treatment at standard
doxorubicin doses (<=300mg/m2) along with those pixantrone recipients who had
received extensive prior doxorubicin treatment compared to historically
reported rates when treated with standard doxorubicin," stated Mr. Philips.
"Despite patients receiving a median total cumulative doxorubicin equivalent
dose of 535mg/m2, the frequency of CHF among PIX 301 recipients was non-dose
dependant and was markedly lower than that reported for doxorubicin at similar
levels of treatment."
At a cumulative total doxorubicin equivalent exposure of > 600mg/m2, the
frequency of CHF among PIX 301 recipients was 4% compared to 48% reported for
doxorubicin.
Incidence Clinical CHF- related or unrelated to drug
Dose (mg/mg2 doxorubicin Doxorubicin(1) Pixantrone
equivalents) N=620 N=70
<=300 mg/m2 5.6% 2/68
500 mg/m2 15% 2/43
600 mg/m2 32% 0/36
>600 48% 1/25
(1) Cancer 97: 2869, 2003
The EXTEND clinical trial was a phase III single-agent trial of pixantrone for
patients with relapsed, aggressive NHL who received two or more prior
therapies and who were sensitive to treatment with anthracyclines. 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.
CTI previously announced that its pivotal phase III (PIX 301) EXTEND trial had
achieved its primary endpoint with patients randomized to treatment with
pixantrone achieving a significantly higher rate of confirmed (CR) and
unconfirmed complete remissions (CRu) 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) with no patients in the
standard chemotherapy arm achieving a confirmed complete remission.
Pixantrone recipients had a low incidence of severe neutropenia complicated by
either fever or documented infections, or severe vomiting or diarrhea.
Pixantrone patients also experienced a low incidence of hair loss, a very
common side effect of other drugs in this class. Overall, the incidence of
serious adverse events was similar between pixantrone and the control arm. The
pixantrone patients had a higher incidence of leucopenia and neutropenia.
Disease progression reported as an adverse event was less frequent in the
pixantrone than in the control arm (1.5% vs. 13.4%).
CTI will be presenting additional new efficacy and safety data at the upcoming
American Society of Clinical Oncology Annual Meeting to be held from May 29 to
June 2, 2009 in Orlando, Florida.
In April 2009, CTI began a rolling submission of a New Drug Application (NDA)
with the U.S. Food and Drug Administration (FDA) for pixantrone to treat
relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL). CTI expects to
complete the submission this quarter and will request priority review, which
if granted could lead to an approval decision from the FDA in Q4 2009.
Pixantrone is also now available in Europe on a named-patient basis.
About Pixantrone
Pixantrone (BBR 2778), is a novel major groove binder with an
aza-anthracenedione molecular structure that differentiates it from the
anthracyclines and other related chemotherapy agents. Anthracyclines are the
cornerstone therapeutic for the treatment of lymphoma, leukemia, and breast
cancer. Although they are sufficiently effective to be used as first-line
(initial) treatment, they cause cumulative heart damage that may result in
congestive heart failure many years later. As a result, there is a lifetime
limit of anthracycline doses and most patients who previously have been
treated with an anthracycline are not able to receive further anthracycline
treatment if their disease returns. Pixantrone has been designed to reduce the
potential for these severe cardiotoxicities without sacrificing anti-cancer
activity. It also can be administered through a peripheral vein rather than a
central implanted catheter as required for other drugs in this class.
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
www.CellTherapeutics.com.
Sign up for email alerts and get RSS feeds at our Web site,
http://www.CellTherapeutics.com/investors_news.htm
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 relapsed aggressive NHL as determined by the FDA, the
possibility that pixantrone could cause cumulative heart damage, the
possibility that the New Drug Application submission will not be completed in
the second quarter of 2009, that priority review will not be granted by the
FDA and that a decision by the FDA is not rendered in late 2009, 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, CTI 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: media@ctiseattle.com
www.CellTherapeutics.com/press_room
Investors Contact:
Ed Bell
T: 206.282.7100
Lindsey Jesch
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.
Media, Dan Eramian, +1-206-272-4343, cell, +1-206-854-1200,
media@ctiseattle.com, or Investors, Ed Bell, +1-206-282-7100, Lindsey Jesch,
+1-206-272-4347, fax, +1-206-272-4434, invest@ctiseattle.com; or Medical
Information, 1-800-715-0944, info@askarm.com
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