Point Therapeutics Provides Preliminary Results from Phase 2 Metastatic Pancreatic Cancer Study
January 12 2007 - 6:44AM
Business Wire
Point Therapeutics, Inc. (NASDAQ: POTP) today provided preliminary
results from the Company�s open-label Phase 2 trial of talabostat
plus gemcitabine in patients with metastatic pancreatic cancer
(Stage IV) who have not received prior chemotherapy. Of the 21
evaluable patients who entered the study at least six months ago,
ten (48%) have survived more than six months. In addition, 31
patients are currently evaluable for tumor response. To date, three
patients (9.7%) have demonstrated a clinical response to treatment,
including one complete response and two partial responses. One
patient with metastatic disease to the liver experienced a complete
response to treatment�defined as the complete disappearance of
tumor. Thus far, no unexpected toxicities have been seen in the
trial that would prevent the Company from continuing to study
talabostat in combination with gemcitabine. The Phase 2 study is a
single-arm, two-stage study in up to 60 evaluable patients with
metastatic pancreatic cancer. The primary clinical endpoint is
six-month survival. Secondary study endpoints include overall
survival, progression-free survival, quality of life, and
performance status. The Phase 2 study protocol called for an
interim assessment before advancing the study to completion. Based
on the preliminary six-month survival results and the responses
seen to date, the Company has decided to advance the study to
completion. Final results from the study are expected mid-year
2007. "Metastatic pancreatic cancer represents a significant unmet
medical need as there are limited treatment options available for
patients. I am pleased with the activity seen to date in this
trial, especially with an oral agent, and look forward to
evaluating further data as it becomes available," said Dr. Yagnesh
Oza, MD, Medical Director at the Center for Comprehensive Cancer
Care in Mt. Vernon, IL and an investigator in the study. �It�s
encouraging to see Point�s preclinical work potentially translating
into clinical benefits for patients,� said Dr. George Demetri, a
member of Point's Clinical Advisory Board and Director of the
Ludwig Center at Dana-Farber/Harvard. �Point has demonstrated
preclinically that talabostat is a potent inhibitor of fibroblast
activation protein (FAP), an enzyme that is highly expressed in
pancreatic cancer and is believed to promote tumor growth. In
addition, preclinical work combining talabostat with gemcitabine
has also demonstrated encouraging results. I believe these factors
make pancreatic cancer a promising target for the study of
talabostat,� concluded Dr. Demetri. About Pancreatic Cancer:
According to the American Cancer Society, pancreatic cancer is the
fourth leading cause of cancer death in the United States. In 2006
alone, 33,730 new cases of pancreatic cancer were diagnosed and
32,300 people died of the disease. The main reason for the poor
prognosis of pancreatic cancer is that patients usually have no
symptoms until the cancer has spread to other organs, and, as a
result, very few of these cancers are found early. Patients with
Stage IV disease have the most advanced form of pancreatic cancer,
which includes metastatic disease to distant organ(s). About Point
Therapeutics, Inc.: Point is a Boston-based biopharmaceutical
company which is currently studying its lead product candidate,
talabostat, in two Phase 3 double blind placebo-controlled trials
in non-small cell lung cancer and in a Phase 2 trial in combination
with gemcitabine in metastatic pancreatic cancer. Point has also
studied talabostat in several Phase 2 trials, including as a
single-agent in metastatic melanoma, in combination with cisplatin
in metastatic melanoma and in combination with rituximab in
advanced chronic lymphocytic leukemia. Certain statements contained
herein are not strictly historical and are "forward looking"
statements as defined in the Private Securities Litigation Reform
Act of 1995. These statements include, without limitation,
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," "projects," "should," "seeks," "plans,"
"schedules 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, filed with the Securities and Exchange Commission on November
9, 2006, and from time to time in Point�s other reports filed with
the Securities and Exchange Commission.
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