Maybe one day, they'll quit pouring money down the Xyotax drain...
Cell Therapeutics, Inc. (CTI) Temporarily Suspends Enrollment on PIONEER Lung Cancer Clinical Trial; Current Patients Continue to Be Treated
prnews
Company to Amend XYOTAX(TM) PIONEER Trial Based on Guidance from FDA Regarding Primary Endpoint Selection and Analysis
SEATTLE, Nov. 3 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI)
(Nasdaq: CTIC; MTAX) reported today that enrollment on its PIONEER lung cancer
clinical trial has been temporarily suspended while the Company awaits follow
up data of recently enrolled patients. After consultation with the Company and
the study's steering committee, the Data Safety Monitoring Board (DSMB)
recommended and CTI agreed to suspend enrollment on the trial to allow
maturity of the data and assessment of differences in early cycle deaths
observed between arms of the study. While most of the deaths were attributed
to disease progression, more complete data is required to analyze this
difference. Also according to the recommendation of the DSMB, all patients who
are currently on the trial will continue to be treated per the protocol.
In addition, as a planned follow up to its May meeting with and following
recommendations from the U.S. Food and Drug Administration (FDA), the Company
reviewed the demographic and estrogen data of the patients on the PIONEER
study and plans to amend the current study while enrollment is suspended. The
study will be amended to focus on the primary efficacy endpoint of survival in
women with normal estrogen levels; the subset of patients that demonstrated
the greatest survival benefit in the STELLAR trials.
"Following our meeting with the FDA, we decided to use the initial
enrollment in this study to determine whether the proportion of patients who
have normal estrogen levels is equivalent to what was expected based on our
experience in the STELLAR trials," said James A. Bianco, M.D., President and
CEO of CTI. "Given that only approximately one-half of patients sampled have
normal estrogen levels in the PIONEER trial compared to approximately two-
thirds of patients for which estrogen data was available in our prior STELLAR
trials, we decided it would be prudent to amend the protocol to focus the
primary endpoint analysis on the subgroup of patients in which we saw the
greatest survival difference in our STELLAR trials -- patients with normal
estrogen levels."
The PIONEER study was initiated in December 2005 using pre-menopausal age
to stratify patients. Based on feedback from the FDA, CTI will utilize the
Agency's recommendation to amend the protocol to use estrogen level as a
stratification factor and as the primary efficacy endpoint of the study. The
Company expects to submit an amendment to the FDA under a Special Protocol
Assessment request as soon as practicable. The Company anticipates the change
to the protocol will push the interim analysis of the PIONEER trial back by at
least six months.
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