Point Therapeutics (MM) (NASDAQ:POTP)
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Point Therapeutics, Inc. (NASDAQ:POTP) presented
positive results from the company's Phase 2 study of talabostat in
combination with docetaxel in patients with advanced non-small cell
lung cancer (NSCLC) in a poster session at the AACR-EORTC-NCI
International Conference on Molecular Targets and Cancer Therapeutics
in Philadelphia, PA.
The trial enrolled 55 patients--42 of whom met evaluability
criteria for response. Five patients demonstrated a clinical response
to treatment as defined by World Health Organization criteria (a 50%
or greater reduction in tumor size) for a response rate of 11.9%. Two
of these patients had a complete response, defined as a complete
disappearance of their tumor. The first complete responder was
observed in March 2005 and the second in April 2005; both patients
continue to be in complete response. The current Kaplan-Meier estimate
of median progression-free survival is 4.2 months and median survival
is estimated at 8.4 months. To date, the one-year survival rate is 48%
for the 31 patients who have been in the study for at least one year.
The objective response rate, progression-free survival, median
survival and one-year survival rates compare favorably to the
historical docetaxel data from three randomized, independent Phase 3
clinical trials. In these historical trials, approximately 96% of all
patients had failed only a first-line treatment while 4% had failed
both first- and second-line treatment. By contrast, in the
talabostat/docetaxel combination trial, 64% of patients had failed
first-line treatment while 36% had failed both first- and second-line
treatment. Additionally, approximately 75% of the patients in the
talabostat study had received a prior platinum-based combination
treatment with either docetaxel or another taxane.
"It is important to note that of the five responders, two had a
complete response, which is very unusual and quite significant in a
second- or third-line setting in advanced non-small cell lung cancer.
We also saw a clinically meaningful increase in progression-free
survival--which is the primary clinical endpoint for regulatory
approval in talabostat's Phase 3 non-small cell lung cancer trials,"
said Dr. Casey Cunningham, an oncologist at Mary Crowley Medical
Research Center in Dallas, TX and a member of Point's Clinical
Advisory Board. "Also, the median and one-year survival results
compare favorably to historically reported results, and talabostat did
not substantially alter the safety profile of docetaxel. In addition,
the oral availability of talabostat is convenient for patients and
offers physicians dosing flexibility. I believe that talabostat has
the potential to become an important treatment for non-small cell lung
cancer and that the initiation of Point's Phase 3 clinical program in
October was a significant step towards achieving this goal."
"Point reached a major milestone in the company's history when we
initiated our Phase 3 program in non-small cell lung cancer. We are
actively enrolling patients into the study and our first patient has
received study medication," said Don Kiepert, President and CEO of
Point Therapeutics, Inc. "We are excited about the potential for
talabostat to become an important addition to the therapies available
to the non-small cell lung cancer patient population."
About Point Therapeutics, Inc.:
Point is a Boston-based biopharmaceutical company developing a
family 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 a Phase 3 trial 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, the timing of initiation and completion of its clinical
trials, and the potential of talabostat to become an important
treatment for non-small cell lung cancer. 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.