Point Therapeutics (MM) (NASDAQ:POTP)
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Point Therapeutics, Inc. (NASDAQ: POTP) today announced that the U.S.
Food and Drug Administration (FDA) has placed the clinical program for
talabostat on clinical hold as a result of the interim analyses of the
Company’s two Phase 3 talabostat studies as a
potential treatment for patients with advanced non-small cell lung
cancer (NSCLC). The Company’s Independent Data
Monitoring Committee recommended stopping both studies due to neither
the primary endpoint of median progression-free survival (PFS) nor the
secondary endpoint of overall survival demonstrating improvement over
the placebo groups. In addition, in the talabostat combination trial
with docetaxal (Taxotere®:
sanofi-aventis), the talabostat arm of the study demonstrated
significantly lower overall survival than the placebo arm. As a result
of the Company informing the FDA of the interim results, the FDA has put
the Company’s talabostat clinical program on
hold.
“We are obviously surprised and disappointed
with the results of both Phase 3 studies,”
said Don Kiepert, President and CEO. “We are
focusing on the best interests of the patients and making sure all this
information is being communicated to the appropriate medical and
regulatory authorities as quickly as possible. We are also assessing our
options given this data and will report on next steps once they have
been decided.”
Talabostat’s NSCLC program consisted of two
randomized, placebo-controlled, double-blind Phase 3 studies in the
second-line and third-line setting. The first Phase 3 study evaluated
talabostat and pemetrexed (Alimta®
: Eli Lilly) versus placebo and pemetrexed. The second Phase 3 study
evaluated talabostat and docetaxal versus placebo and docetaxal. The
primary endpoint in both studies was PFS with overall survival as a
secondary endpoint.
About Point Therapeutics, Inc.:
Point is a Boston-based biopharmaceutical company which has studied its
lead product candidate, talabostat, in two Phase 3 double blind
placebo-controlled trials in metastatic non-small cell lung cancer and
in several Phase 2 trials, including as a single-agent in metastatic
melanoma, in combination with cisplatin in metastatic melanoma, in
combination with rituximab in advanced chronic lymphocytic leukemia and
in combination with gemcitabine in Stage IV pancreatic cancer.
Certain statements contained herein are not strictly historical and
are "forward-looking" statements as defined in the Private Securities
Litigation Reform Act of 1995. 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.