Point Therapeutics Announces Positive Results at AACR-EORTC-NCI Conference from Phase 2 Talabostat Non-Small Cell Lung Cancer St
November 16 2005 - 8:25AM
Business Wire
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.
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