Point Therapeutics (MM) (NASDAQ:POTP)
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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.