Maybe he didn't like this PR... There were a couple good points in it.
Ian
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Data from XYOTAX(TM) Clinical Program Presented at the 11th World Conference on Lung Cancer
prnews
BARCELONA, July 6 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI)
(Nasdaq: CTIC; Nuovo Mercato) reported on presentations of XYOTAX at the
International Association for the Study of Lung Cancer (IASLC) 11th World
Conference on Lung Cancer. In an oral session on advanced lung cancer, results
of the STELLAR phase III clinical trials were presented. In addition, XYOTAX
was highlighted in a Symposium and the pharmacokinetic properties of XYOTAX
were highlighted in a poster presentation.
In general, results from the phase III studies demonstrated comparable or
superior efficacy, a significant reduction in most taxane-related side
effects, a reduction in requirements for transfusions and growth factors, and
more convenient administration of XYOTAX when compared to the control arms,
which included docetaxel, paclitaxel/carboplatin, and gemcitabine or
vinorelbine. When compared to vinorelbine (32 patients) on the STELLAR 4
trial, XYOTAX patients demonstrated superior survival. In addition, in the
first-line STELLAR 3 and 4 trials in poor performance status (PS2) patients,
XYOTAX demonstrated a statistically significant increase in survival among
women (198 patients total), with a 60 percent increase in 1-year survival.
"The survival advantage seen in women in the STELLAR 3 and 4 studies is
worthy of note. The trials were stratified by gender and survival by gender is
pre-specified in the analysis plan," stated Scott C. Stromatt, M.D., Sr. Vice
President of Clinical Development and Regulatory Affairs at CTI. "We plan to
explore these results later this summer in our discussions with FDA regarding
the regulatory submission for XYOTAX."
XYOTAX(TM) (paclitaxel poliglumex, PPX): pharmacokinetic evidence for
prolonged tumor exposure and reduced systemic exposure to paclitaxel (Abstract
905.00 - Monday, July 4, 2005, 8:00 a.m. CET)
In a poster presentation, Alberto Bernareggi, M.D., of CTI presented
preclinical and clinical pharmacokinetic results demonstrating that XYOTAX is
stable in systemic circulation, has a low volume of distribution and a low
clearance, accumulates in tumor, and releases paclitaxel progressively, thus
providing prolonged tumor and systemic exposure. These results support the
improved tolerability profile with similar efficacy of XYOTAX compared to
paclitaxel observed in the STELLAR 3 phase III trial in PS2 NSCLC patients
comparing the two drugs in combination with carboplatin.
Improving outcomes for PS2 patients: Results of the XYOTAX(TM) phase III
STELLAR trials (Symposium - Tuesday, July 5, 2005, 8:00 - 9:30 a.m. CET)
XYOTAX was featured in a symposium on PS2 NSCLC chaired by Mark Green,
M.D., of Medical University of South Carolina. At the symposium, Kenneth J.
O'Byrne, M.D., of St. James's Hospital, outlined the results in women from the
first-line STELLAR trials. In the 198 women on STELLAR 3 and 4, the median
survival was approximately 9.5 months vs. 7.8 months, 1-year survival survival
was 40% vs. 25%, and 2-year survival was 14% vs. 5% (hazard ratio = 0.70, log
rank p-value = 0.03) for women treated with XYOTAX/carboplatin and XYOTAX as a
single-agent compared to women on the control arms (paclitaxel/carboplatin and
gemcitabine or vinorelbine).
XYOTAX(TM) vs. docetaxel for the second-line treatment of non-small cell
lung cancer (NSCLC): the STELLAR 2 phase III study (Paper #2043.00 -
Wednesday, July 6, 2005, 2:30 - 4:30 p.m. CET)
Luis Paz-Ares, M.D., of Hospital Doce De Octubre of Madrid, presented
results of the STELLAR 2 clinical trial for the first time in a peer-reviewed
meeting. The trial demonstrated that XYOTAX had similar efficacy compared to
docetaxel, with fewer side effects, except for neuropathy (all grades, 50
percent for XYOTAX vs. 30 percent for docetaxel), and fewer severe (grade 3/4)
side effects, except for hypersensitivity reactions (3 percent for XYOTAX vs.
<1 percent for docetaxel), resulting in less supportive care needed by
patients on the XYOTAX arm of the study. Patients on XYOTAX required less
epoetin (a substance that stimulates the bone marrow to make red blood cells),
fewer growth factors, and fewer red blood cell transfusions. XYOTAX was given
in a convenient administration (mean infusion times were 19 minutes vs. 68
minutes for XYOTAX and docetaxel, respectively) without the requirements for
premedications. Paz-Ares concluded that as a result of the long half-life of
XYOTAX, dose reductions for XYOTAX are recommended for grade 1 neuropathy.
XYOTAX(TM)/carboplatin vs. paclitaxel/carboplatin for the treatment of PS2
patients with chemotherapy-naive advanced non-small cell lung cancer (NSCLC):
the STELLAR 3 phase III study (Paper #2051.00 - Wednesday, July 6, 2005, 2:30
- 4:30 p.m. CET)
Corey J. Langer, M.D., of Fox Chase Cancer Center in Philadelphia,
presented the STELLAR 3 clinical trial results, which were previously
presented at the 2005 Annual Meeting of the American Society of Clinical
Oncology (ASCO). The overall survival for the study was longer than previously
reported for this group of patients, with comparable survival for both arms of
the study. Regional differences were noted in the survival; patients in the
ROW (mostly Eastern European) region had a statistically significant increase
in survival (8.7 month median survival vs. 6.5 months for the other regions,
p<0.001). Severe (grade 3/4) side effects were comparable on both arms, with
more neuropathy and thrombocytopenia seen in the XYOTAX arm (17 percent vs. 10
percent and 16 percent vs. 4 percent, respectively). Similar to the STELLAR 2
presentation, Langer concluded that dose reductions should be recommended for
grade 1 neuropathy as a result of the delayed time to neuropathy experienced
by the XYOTAX patients. Mean administration time for XYOTAX plus carboplatin
was 48 minutes compared to 224 minutes for paclitaxel plus carboplatin.
XYOTAX(TM) vs. gemcitabine or vinorelbine for the treatment of performance
status (PS) 2 patients with chemotherapy-naive advanced non-small cell lung
cancer (NSCLC): the STELLAR 4 phase III study (Paper #2057.00 - Wednesday,
July 6, 2005, 2:30 - 4:30 p.m. CET)
Mary O'Brien, M.D., of Royal Marsden Hospital in London, presented
detailed results of the STELLAR 4 clinical trial for the first time in a peer-
reviewed meeting. The trial demonstrated that XYOTAX had similar efficacy
compared to the control arm (either vinorelbine or gemcitabine), and the
median survival of XYOTAX as a single-agent was similar to taxane/platinum
doublet therapy. In addition, it was noted that women had a survival
advantage, with median survival of 10.4 months, 43 percent 1-year survival,
and 30 percent 2-year survival, compared to 7.0 months, 26 percent (p = 0.04),
and 6 percent (p = 0.02), respectively, for the control arm. Similar to the
STELLAR 2 study, the side effect profile for XYOTAX was better than the
control arm, except for neuropathy (grade 3, 4 percent vs. 0 percent),
resulting in significantly less need for supportive care, including less
epoetin, fewer growth factors, and less new opiate use for patients on the
XYOTAX arm. XYOTAX was more convenient to administer (mean infusion times were
12 minutes vs. 30 minutes for XYOTAX and the control arm, respectively) and
significantly more patients received full course of therapy compared to the
control arm.
About XYOTAX(TM)
[snip] |
