Point Therapeutics (MM) (NASDAQ:POTP)
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Point Therapeutics, Inc. (NASDAQ: POTP) today provided a clinical update
on its current clinical program which includes two Phase 3 trials in
Stage IIIB/IV non-small cell lung cancer (NSCLC) and a Phase 2 trial in
Stage IV pancreatic cancer.
Phase 3 Non-Small Cell Lung Cancer
Registration Program
Point’s NSCLC program consists of two
randomized, placebo-controlled, double-blind Phase 3 studies in the
second-line and third-line setting. The first Phase 3 study evaluates
talabostat and pemetrexed (Alimta®:
Eli Lilly) versus placebo and pemetrexed. The second study evaluates
talabostat and docetaxel (Taxotere®:
sanofi-aventis) versus placebo and docetaxel. Each study was intended to
enroll approximately 400 patients, with an estimated 200 patients per
treatment arm. Enrollment in the talabostat/pemetrexed study is on
schedule with full enrollment expected in the second quarter of 2007 and
results projected in the fourth quarter of 2007. In the
talabostat/docetaxel study enrollment is currently behind the Company’s
original schedule. "In my experience, many studies of docetaxel in
non-small cell lung cancer are enrolling slowly, primarily due to the
increasing use of pemetrexed in the second- and third-line treatment
setting, and the increasing use of docetaxel in the front-line setting,"
said Dr. Chandra Belani, a professor of medicine in the division of
hematology/oncology at the University of Pittsburgh School of Medicine,
co-director of the Lung and Esophageal Cancer Program at the University
of Pittsburgh Cancer Institute and a consultant for Point. "It is
becoming increasingly difficult for sponsors to enroll large studies
using docetaxel as a comparator due to this shifting treatment paradigm.”
Given these factors, the Company is currently evaluating multiple
options, including initiatives to speed the rate of enrollment and
potentially restructuring the trial by downsizing the total number of
patients enrolled in the trial while increasing the treatment effect
needed to demonstrate statistical significance. The Company will
continue to provide guidance on this study as decisions are made
regarding next steps.
Phase 2 Stage IV Pancreatic Cancer Study
In early January of 2007, the Company provided preliminary results from
their open-label Phase 2 trial of talabostat plus gemcitabine (Gemzar®:
Eli Lilly) in patients with Stage IV pancreatic cancer who had not
received prior chemotherapy. The primary clinical endpoint for this
study is six-month survival, and secondary study endpoints include
overall survival, progression-free survival, quality of life, and
performance status. Previously, the Company reported that ten of 21
patients evaluable for six-month survival had survived more than six
months and that three of 31 patients evaluable for tumor response had
demonstrated a clinical response to treatment, including one complete
response in a patient with metastatic disease to the liver. The Company
recently completed enrollment (51 evaluable patients/70 intent-to-treat)
in the study and has since determined that it will not meet the primary
endpoint of six-month survival. Of note, to date, an additional patient
has demonstrated a partial clinical response to treatment. The Company
will continue to monitor patients for tumor response as well as other
secondary endpoints. This study will be completed and final results
continue to be expected in mid-year 2007.
“Stage IV pancreatic cancer is an extremely
difficult cancer to treat, and we were pleased by the complete and
partial responses seen to date in this study. We believe these responses
may be clinically meaningful and intend to thoroughly evaluate all
secondary endpoints before determining the clinical path forward for
this indication,” said Don Kiepert, President
and CEO of Point Therapeutics. “We continue to
make progress with our Phase 3 non-small cell lung cancer program and
are working actively with our advisors to determine the best course of
action for the talabostat and docetaxel study. We are very pleased with
the speed of enrollment in our study of talabostat and pemetrexed. The
fact that pemetrexed continues to gain market share in the second- and
third-line setting reinforces the importance of this study, and we
continue to expect results from this study by the end of the year,”
concluded Kiepert.
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 non-small cell lung cancer (NSCLC)
and in a Phase 2 trial in combination with gemcitabine in metastatic
pancreatic cancer. Point has also studied talabostat 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 docetaxel in NSCLC.
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 statement due to risks and
uncertainties to which the Company is subject, including uncertainty as
to whether enrollment in the Company's talabostat/pemetrexed study will
be fully enrolled by the second quarter of 2007; uncertainty as to
whether results from the Company's talabostat/pemetrexed study will be
available in the fourth quarter of 2007; uncertainty as to whether the
responses seen to date in the Company's Phase 2 pancreatic cancer study
may be clinically meaningful; uncertainty whether final results from the
Company's Phase 2 pancreatic cancer study will be available by mid-year
2007; uncertainties related to the Company's ability to raise the
additional capital needed to fund completion of its clinical trials; and
other factors that are described in Form 8-K filed with the Securities
and Exchange Commission on February 8, 2007, and from time to time in
Point's other reports filed with the Securities and Exchange Commission.