Point Therapeutics Announces Results From Phase 2 Metastatic Melanoma Clinical Program at iSBTc Conference
November 11 2005 - 8:12AM
Business Wire
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.
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