Compared to Standard Therapies, Pixantrone Decreases Time to Achieve Complete Remission by 47% in Relapsed Aggressive Non-Hodgkin’s Lymphoma
(Nasdaq and MTA: CTIC) announced today that updated safety and efficacy data
from the phase III trial of pixantrone provides further support for a robust
clinical benefit for pixantrone when used as single agent therapy in the
treatment of multiple relapsed aggressive non-Hodgkin’s lymphoma (NHL). On an
intent-to-treat analysis, pixantrone recipients who achieved a complete
remission did so during the first 2 cycles of therapy, compared to 4 cycles
among standard chemotherapy recipients, (1.9 months vs. 3.6 months, pixantrone
vs. standard chemotherapy). The duration of response in the patients was
similar in the 37% of pixantrone patients who had either a partial or complete
response compared to the 14% of comparator patients with a major response.
However, the overall progression free survival (PFS) was significantly longer
in the pixantrone arm (4.7 months vs. 2.6 months, hazard ratio = 0.6; p =
0.0074, pixantrone vs. standard chemotherapy). Thirty-two percent (32%) of
pixantrone patients received all 6 cycles of therapy, with 84% receiving 5 of
6 cycles of treatment. 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 and numerically more severe cardiac events (4 vs 2) than in the
control arm. Disease progression reported as an adverse event was less
frequent in the pixantrone than in the control arm (1.5% vs. 13.4%).
“We were impressed to see that 84% of patients received at least 5 cycles
of pixantrone therapy with a median total dose of 1,475 mg, despite having had
significant prior therapy with doxorubicin, an agent in a similar class with
cumulative cardiotoxicity,” noted
CTI. “The rapid time-to-response data coupled with the relatively low
incidence of traditional anthracycline toxicities and a safety profile that
compares favorably to standard chemotherapy, positions pixantrone to live up
to the promise of providing patients with relapsed aggressive NHL a meaningful
CTI announced in
endpoint of its phase III EXTEND (PIX301) trial of pixantrone (BBR2778).
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.
CTI expects to begin submission of a rolling New Drug Application (NDA)
and request priority review for pixantrone to treat relapsed aggressive non-
Hodgkin’s lymphoma ( NHL) in the first quarter of 2009. If granted priority
review a decision on the NDA could occur before the end of 2009.
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.
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,
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 Cell Therapeutics, Inc.
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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 the potential
failure of pixantrone to prove safe and effective for treatment of relapsed
aggressive NHL as determined by the FDA, 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.
Media Contact: Dan Eramian T: 206.272.4343 C: 206.854.1200 E: firstname.lastname@example.org http://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: email@example.com http://www.CellTherapeutics.com/investors
SOURCE Cell Therapeutics, Inc.