Point Therapeutics (MM) (NASDAQ:POTP)
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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.