Point Therapeutics Summarizes New Data Evaluating Its Lead Compound, Talabostat, in Four Distinct Cancers at the 2006 American
08 June 2006 - 9:00PM
Business Wire
Point Therapeutics, Inc. (NASDAQ: POTP) announced today that new
data evaluating talabostat's anti-tumor activity in Phase 2 studies
in advanced chronic lymphocytic leukemia (CLL), metastatic
melanoma, metastatic colorectal cancer and in a preclinical
osteosarcoma model were presented at the 42nd American Society of
Clinical Oncology (ASCO) Annual Meeting in Atlanta, Georgia. These
studies are part of talabostat's broad clinical program, which
includes two Phase 3 trials in metastatic non-small cell lung
cancer and Phase 2 trials in advanced CLL, metastatic melanoma and
metastatic pancreatic cancer. "These studies add to the growing
body of evidence supporting talabostat's anti-tumor activity in
multiple indications," said Dr. Margaret Uprichard, Point's Senior
Vice President and Chief Development Officer. "We continue to see
clinical activity in patients with very advanced disease who have
failed multiple therapies and for whom there are few or no approved
treatments." Talabostat is an oral, targeted therapy, which is
currently in clinical development for potential use in oncology.
Talabostat is a known dipeptidyl peptidase (DPP) inhibitor. DPPs
are enzymes that appear to regulate several different physiological
processes including those involved in tumor growth and host
responses to cancer, type 2 diabetes, and immune responses to
vaccines. The Company believes that talabostat employs a novel dual
mechanism of action by (1) targeting a DPP called fibroblast
activation protein (FAP) that is uniquely expressed in the tumor
stroma, or connective tissue of the tumor, while (2) concurrently
stimulating the immune system through the inhibition of DPP 8 and
9, enabling the body to promote its natural ability to attack
tumors. The following highlights the data presented at the ASCO
Annual Meeting: Advanced Chronic Lymphocytic Leukemia - Phase 2
study of talabostat and rituximab in
fludarabine/rituximab-resistant or refractory patients with CLL
(Abstract # 6598) - lead author: Dr. Khuda Khan, Indiana Oncology
and Hematology Consultants This ongoing Phase 2 trial is an
open-label, single-arm, multi-center study of talabostat and
rituximab in patients who have failed to respond or progressed
following a prior treatment with fludarabine. These patients are
considered salvage patients--the vast majority (81.3%) have been
previously treated with a rituximab regimen and 41.6% also received
alemtuzumab. More than 60% of the patients enrolled in the study
are Rai Stage IV--the most advanced stage of disease in CLL. To
date, of the 48 patients enrolled, 42 meet criteria for
evaluability (at least six days of talabostat). Investigators
reported clinical responses in eight patients for an overall
response rate of 19%. Of interest, six of the eight patients who
demonstrated a clinical response had previously failed rituximab.
In addition, three of these six patients had also failed
alemtuzumab treatment--the only approved treatment for patients who
fail fludarabine. Median progression-free survival (PFS) in the
intent-to-treat population is currently 3.6 months. Metastatic
Melanoma: - Phase 2 trial of talabostat and cisplatin in patients
with stage IV melanoma (Abstract #8040) - lead author: Dr. Casey
Cunningham, Mary Crowley Medical Research Center This Phase 2 trial
was an open-label, single-arm, multi-center study of talabostat and
cisplatin with Stage IV melanoma. The majority of these patients
had extensive disease, including metastases to the liver and lungs.
Most (64.9%) had received prior treatment for Stage IV disease and,
of these, 64.5%, were treated with interleukin-2 (IL-2) or
interferon treatment. Of the 43 patients who met criteria for
evaluability (completion of 2 cycles), investigators reported
clinical responses in six patients for an overall response rate of
13.9%. Stable disease of at least three months was observed in 20
of 43 evaluable patients. The estimates of median PFS and survival
in the intent-to-treat population are 2.8 months and 8.5 months,
respectively. Metastatic Colorectal Cancer - Phase 2
pharmacodynamic study of the fibroblast activation protein
inhibitor Val-boro-Pro in patients with metastatic colorectal
cancer (Abstract #3594) -lead author: Dr. Jonathan Cheng, Fox Chase
Cancer Center This investigator sponsored Phase 2 study of
single-agent talabostat (Val-boro-Pro) in patients with metastatic
colorectal cancer was designed as a pharmocodynamic study of
talabostat's fibroblast activation protein (FAP) inhibition
properties. In this study, blood samples were collected from
patients to evaluate serum levels of antiplasmin, which are thought
to be regulated by FAP. The Company and the investigator believe
that anti-plasmin cleaving enzyme (APCE) is homologous to FAP, but
as a secreted form. This study is important because it suggests in
humans that talabostat is inhibiting a circulating form of FAP in
the blood--marking the first time talabostat's mechanism of action
has been directly noted in humans. The 28 patients enrolled in this
trial are considered salvage patients, meaning they had failed
standard treatments, and the median number of prior treatment
failures was four. All patients had metastatic disease, with 79% of
the patients having metastases to the liver. Importantly, six
patients (21%) in the study had stable disease at eight weeks and
the median time to progression for these patients was 26 weeks.
Prior to receiving talabostat, the median progression-free interval
for these patients was 13 weeks. Murine Osteosarcoma Model -
Reduction of murine osteosarcoma lung metastases using the
dipeptidyl peptidase inhibitor, talabostat (Abstract #9009) -lead
author: Dr. Su Young Kim, National Cancer Institute This
investigator sponsored preclinical study of talabostat in a murine
osteosarcoma model was designed to study, for the first time,
talabostat's anti-metastatic properties. Mice treated with
talabostat had a ten-fold decrease in the number of visible lung
metastases. Talabostat also decreased the formation of primary
tumors and improved survival in these mice. About Point
Therapeutics, Inc.: Point is a Boston-based biopharmaceutical
company developing a portfolio 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 two Phase 3 trials in non-small cell lung cancer.
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," "schedules to," "projects," "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 March 31, 2006
and from time to time in Point's periodic and other reports filed
with the Securities and Exchange Commission.
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