Point Therapeutics Initiates Phase 2 Clinical Trial of Talabostat in Advanced Pancreatic Cancer
June 23 2005 - 6:30AM
Business Wire
Point Therapeutics, Inc. (NASDAQ:POTP) announced today that it has
initiated a Phase 2 clinical trial of the Company's lead
therapeutic compound, talabostat, for the treatment of metastatic
pancreatic cancer. The study is designed to evaluate the anti-tumor
activity of talabostat in combination with gemcitabine in patients
with metastatic pancreatic cancer. The trial design is a
single-arm, two-stage study in up to 60 patients with metastatic
pancreatic cancer. The primary clinical endpoint will be six-month
survival. Secondary study endpoints include overall survival,
progression-free survival, quality of life, and performance status.
"We are very pleased to have initiated our fifth Phase 2 talabostat
study," said Don Kiepert, President and CEO of Point Therapeutics.
"Our preclinical work with talabostat in combination with
gemcitabine demonstrated encouraging results. Overall tumor
rejection rates in mice increased to 45% when treated with the
talabostat/gemcitabine combination as opposed to a 23% rejection
with gemcitabine alone. We are hopeful that these results will
translate into the clinical setting given the lack of options for
patients facing pancreatic cancer." According to the American
Cancer Society, pancreatic cancer is the fourth leading cause of
cancer death in the United States. In 2005 alone, 32,180 new cases
of pancreatic cancer will be diagnosed and 31,800 people will die
of the disease. 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. Its lead product candidate,
talabostat (PT-100), is a small molecule drug in Phase 2 clinical
trials. Talabostat is orally-active and, through a novel mechanism
of action, has the potential to inhibit the growth of malignant
tumors and to support the reconstitution of the hematopoietic
system. In 2004, Point initiated four Phase 2 clinical trials of
talabostat. The trials are studying talabostat in combination with
docetaxel in metastatic non-small cell lung cancer (NSCLC),
talabostat as a single agent in metastatic melanoma, talabostat in
combination with cisplatin in metastatic melanoma, and talabostat
in combination with rituximab in advanced chronic lymphocytic
leukemia (CLL). 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 on the
prospects for our drug development activities and results of
operations based on our current expectations, such as statements
regarding certain milestones with respect to our clinical program
and our product candidates. 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," "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,
but not limited to, the ability of Point to (i) successfully
develop and manufacture products, (ii) obtain external funding to
finance the operations, (iii) obtain the necessary regulatory
approvals, and (iv) obtain and enforce intellectual property
rights, as well as the risk factors described in Point's Quarterly
Report on Form 10-Q filed with the Securities and Exchange
Commission on May 10, 2005 and from time to time in Point's other
reports filed with the Securities and Exchange Commission.
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