Point Therapeutics Provides Clinical Update
March 01 2007 - 7:25AM
Business Wire
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.
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