Point Therapeutics (MM) (NASDAQ:POTP)
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From Jul 2019 to Jul 2024
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.