Point Therapeutics (MM) (NASDAQ:POTP)
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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.