CORRECTING and REPLACING Point Therapeutics Announces Interim Analysis to be Performed on Its Phase 3 Talabostat with Alimta Stu
May 15 2007 - 10:02AM
Business Wire
Please replace the release with the following corrected version due
to multiple revisions. The corrected release reads: POINT
THERAPEUTICS ANNOUNCES INTERIM ANALYSIS TO BE PERFORMED ON ITS
PHASE 3 TALABOSTAT WITH ALIMTA STUDY Point Therapeutics, Inc.
(NASDAQ: POTP) today announced that the Company�s Board of
Directors approved an unscheduled interim analysis on the Phase 3
non-small cell lung cancer (NSCLC) study of talabostat in
combination with pemetrexed (Alimta�: Eli Lilly). The study was
designed to enroll 400 NSCLC patients who have already failed
either one or two prior drug regimens. To date, approximately 360
patients have enrolled in the study. The interim analysis will
examine approximately 150 events that have already been recorded in
this study, with events being defined as either disease progression
or death. The Company expects results from the interim analysis by
the end of this month. �This analysis will produce the first
clinical information on the effects of talabostat in a controlled,
randomized trial,� said Don Kiepert, President and CEO. �We felt
that it was important to have controlled data at this time in order
to properly assist us in our on going strategic and business
initiatives.� Talabostat�s NSCLC program consists of two
randomized, placebo-controlled, double-blind Phase 3 studies in the
second-line and third-line setting. One of the Phase 3 studies is
evaluating talabostat and pemetrexed versus placebo and pemetrexed.
In the interim analysis, median progression-free survival (PFS) and
overall survival data and the statistical analyses of these data
for the talabostat treatment arm will be compared with the control
arm by an independent data monitoring committee. The Company
expects to report on the committee�s recommendation to continue the
trial or stop the trial either due to reaching statistical
significance (p< 0.005) or futility. The Company may also
perform an unscheduled interim analysis on its Phase 3 study
evaluating talabostat in combination with docetaxal (Taxotere� :
sanofi-aventis), although a final decision has not been made.
Originally the pemetrexed study was powered at 80% to detect an
approximate hazard ratio of 1.4 (p=0.05) in PFS over the placebo
arm with a positive trend in overall survival upon final analysis.
The addition of the interim analysis has only slightly modified the
final statistical plans. The trial remains powered at 80% to
demonstrate an approximate hazard ratio of 1.4 in PFS with an
adjusted statistical level of p=0.048. About Point Therapeutics,
Inc.: Point is a Boston-based biopharmaceutical company which is
currently studying its lead product candidate, talabostat, in two
Phase 3 double blind placebo-controlled trials in metastatic
non-small cell lung cancer. Point is also currently studying
talabostat in a Phase 2 trial in combination with gemcitabine in
Stage IV pancreatic cancer. In addition, Point has studied
talabostat in several Phase 2 trials, including as a single-agent
in metastatic melanoma, in combination with cisplatin in metastatic
melanoma and in combination with rituximab in advanced chronic
lymphocytic leukemia. Certain statements contained herein are not
strictly historical and are "forward-looking" statements as defined
in the Private Securities Litigation Reform Act of 1995, including
the Company�s expectation that results from the Company�s interim
analysis are expected by the end of this month, that these results
will assist the Company in making on going strategic and business
decisions, and that the Company may also perform an unscheduled
interim analysis on its Phase 3 study evaluating talabostat in
combination with docetaxal. Forward-looking statements are
statements that are not historical facts, and can be identified by,
among other things, the use of forward-looking language, such as
"believes," "feels," "expects," "may," "will," "projects,"
"should," "seeks," "plans," "schedules to," "anticipates" or
"intends" or the negative of those terms, or other variations of
those terms of comparable language, or by discussions of strategy
or intentions. A number of important factors could cause actual
results to differ materially from those projected or suggested in
the forward-looking statements due to risks and uncertainties to
which the Company is subject, and other factors that are described
in Form 10-Q filed with the Securities and Exchange Commission on
May 10, 2007, and from time to time in Point's other reports filed
with the Securities and Exchange Commission.
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