Point Therapeutics (MM) (NASDAQ:POTP)
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Point Therapeutics, Inc. (NASDAQ: POTP) announced today
that it enrolled the first patient in the company's second Phase 3
clinical trial, which will evaluate talabostat in combination with
pemetrexed versus pemetrexed with placebo in patients with metastatic
non-small cell lung cancer (NSCLC).
This newly initiated Phase 3 trial is being conducted as part of a
Phase 3 clinical program in NSCLC consisting of two randomized, double
blind placebo controlled trials in up to 800 patients at approximately
100 sites in North America. The first 400-patient trial, evaluating
the combination of talabostat with docetaxel versus docetaxel and
placebo, has already opened to enrollment.
"Initiating patient enrollment in our second Phase 3 trial is an
important milestone for talabostat's development and the company
overall," said Don Kiepert, President and CEO of Point Therapeutics,
Inc. "We are excited about studying talabostat in our two Phase 3
trials in metastatic non-small cell lung cancer patients who have
failed at least one prior course of chemotherapy," concluded Kiepert.
The company decided to pursue the Phase 3 program based upon
positive data resulting from the Phase 2 trial in metastatic NSCLC. In
the Phase 2 study combining talabostat with docetaxel, the total
number of observed clinical responses is six, for an overall response
rate of 14.3%. Of the six responding patients, two experienced
complete responses. In addition, of the first 40 patients enrolled in
the study, 48% have survived for at least 12 months.
The Phase 3 program was initiated in October 2005. The primary
study endpoint is progression-free survival. Secondary endpoints
include overall survival, objective response rate, duration of
response and quality of life. Trial results for both studies are
projected for late 2007.
According to the American Cancer Society, lung cancer is the
leading cause of cancer death among men and women in the United States
with nearly 60% of people diagnosed dying within one year and nearly
75% dying within two years. Nearly all lung cancers are non-small
cell. While treatment options for NSCLC continue to emerge, mortality
rates have not improved in the last 10 years, leaving a significant
need for advancement in current therapies.
About Point Therapeutics, Inc.:
Point is a Boston-based biopharmaceutical company developing a
portfolio of dipeptidyl peptidase (DPP) inhibitors for use in cancer,
type 2 diabetes and as vaccine adjuvants. Point is currently studying
its lead product candidate, talabostat, in two Phase 3 trials in
NSCLC. Point is also studying 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
gemcitabine in metastatic pancreatic cancer. In addition, Point's
portfolio includes two other DPP inhibitors in preclinical
development--PT-630 for type 2 diabetes, and PT-510 as a vaccine
adjuvant.
Certain statements contained herein are not strictly historical
and are "forward looking" statements as defined in the Private
Securities Litigation Reform Act of 1995. This information includes
statements with respect to the company's clinical development programs
and the timing of initiation and completion of its clinical trials.
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," "should," "seeks," "plans," "schedule 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, including the risk factors described
in Point's quarterly report on Form 10-Q for the quarter ended
September 30, 2005 and from time to time in Point's periodic and other
reports filed with the Securities and Exchange Commission.