Point Therapeutics (MM) (NASDAQ:POTP)
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Point Therapeutics, Inc. (NASDAQ: POTP) announced
results in the company's Phase 2 single-agent study of its oral
anti-cancer drug candidate, talabostat, in patients with Stage IV
melanoma. These results will be presented in a poster session at the
International Society for Biological Therapy of Cancer meeting in
Alexandria, VA on Saturday, November 12, 2005. The company's
metastatic melanoma clinical program also includes studying talabostat
in a Phase 2 trial in combination with cisplatin.
The single-agent trial included 42 patients with metastatic
melanoma, 31 of whom are evaluable for response. Two patients had a
response to talabostat as defined by RECIST (a 30% or greater
reduction in tumor size) with one of these patients experiencing a
complete response, defined as a complete disappearance of the tumor.
This patient continues to be a complete responder. The current
Kaplan-Meier estimates for single-agent talabostat are 7.1 months for
median survival and 1.5 months for median progression-free survival.
Additionally, in the single-agent talabostat study, 71% of the
patients had visceral brain or bone metastases. Left untreated, their
median survival would be expected to be approximately 4.4 months.
"The results in this trial suggest that talabostat is
demonstrating biological and clinical activity in melanoma as a
single-agent, which is not often seen in this disease. The convenience
of oral dosing is also attractive," said Dr. Thomas Gajewski, a lead
investigator in the study at the University of Chicago Medical Center
and a member of Point's Clinical Advisory Board.
"We are pleased with the median survival and median
progression-free survival results we have seen in our metastatic
melanoma program because we expect these would be the registration
endpoints if we determine to pursue a Phase 3 melanoma trial," said
Dr. Margaret Uprichard, Senior Vice President and Chief Development
Officer of Point Therapeutics, Inc. "In addition to the single agent
trial, we continue to conduct our Phase 2 trial in combination with
cisplatin. Interim results from that trial have shown that of 42
evaluable patients to date, four have had a partial response of 30% or
greater reduction in tumor size. More importantly, interim results
also indicate that median progression-free survival in the intent to
treat population is currently 2.8 months compared to the historically
reported 1.4 to 1.6 months for dacarbazine, the only approved
chemotherapy for metastatic melanoma. We will continue to evaluate the
Phase 2 data from our melanoma program and determine our appropriate
course of action by the end of the year," concluded Dr. Uprichard.
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
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.