Point Therapeutics Announces Interim Analysis to be Performed on Its Phase 3 Talabostat with Alimta Study
May 15 2007 - 8:01AM
Business Wire
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 a 1.4
month improvement (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 a 1.4 month improvement 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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