Point Therapeutics (MM) (NASDAQ:POTP)
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Point Therapeutics, Inc. (NASDAQ: POTP) announced today
that it has advanced its third Phase 2 oncology study with talabostat,
successfully completing the first stage of the company's Phase 2 study
in advanced chronic lymphocytic leukemia (CLL) in combination with
rituximab, a monoclonal antibody.
"The decision to move forward to the second stage of the CLL trial
is an important milestone for talabostat and confirms the potential
versatility of our agent - both across treatment modalities and in
multiple cancers in the clinic," said Dr. Margaret Uprichard, Chief
Development Office and Senior Vice President of Point Therapeutics.
"Talabostat has shown activity in combination with a monoclonal
antibody, approved chemotherapies and as a single-agent. We have seen
positive clinical results in advanced hematologic malignancies and in
two advanced solid tumors - metastatic non-small cell lung cancer and
metastatic melanoma," concluded Dr. Uprichard.
This single-arm trial evaluates talabostat in combination with
rituximab in up to 54 patients with advanced CLL. Thus far, we have
seen a 20% response rate in the first 20 evaluable patients, which was
the targeted response rate needed to continue the study to completion.
The majority of patients in the study had previously not responded to
or had relapsed following prior treatment with rituximab and/or
fludarabine suggesting that the addition of talabostat is providing
additive activity.
Responses are evaluated based on the National Cancer Institute
(NCI) Working Group Guidelines for CLL, which is the standard used in
measuring treatment effectiveness in CLL. Patients who responded to
treatment had a decrease in measurable disease (palpable nodes/organs
and/or CT scan results) along with improvements in hematologic
parameters such as lymphocytes, hemoglobins and platelets. The
preliminary safety profile of talabostat in this study is consistent
with that reported in previous clinical studies.
"Patients who are refractory to fludarabine and/or rituximab
treatment are among the toughest patients to treat," explained Dr.
Khuda Dad Khan, a lead investigator in Point's CLL trial at Indiana
Oncology and Hematology Consultants. "The only approved treatment
option for these advanced patients is often difficult to tolerate and
rituximab has been studied as an alternative to this treatment. The
fact that the addition of talabostat to rituximab is demonstrating
positive results, especially in patients who had failed rituximab in
the past, is very exciting. The toxicity profile is low and because
talabostat is orally administered, it's easy for patients to take at
home - a convenience they like. If we continue to see positive
results, this would be a very welcome treatment option for those who
have exhausted other choices."
"I am very pleased with Point's progress in the clinic. In 2004,
Point initiated four Phase 2 clinical trials of talabostat in
metastatic non-small cell lung cancer, metastatic melanoma and in
advanced chronic lymphocytic leukemia, and, in June of 2005, a fifth
Phase 2 clinical trial in metastatic pancreatic cancer was initiated,"
said Don Kiepert, President and CEO of Point Therapeutics Inc.
"Importantly, the positive results we have seen in the CLL study mark
the third go-decision Point has reached in our Phase 2
programs-further demonstrating the potential breadth and depth of
talabostat as a cancer therapeutic. I am also pleased to note that the
company continues to make positive progress in our Phase 2 metastatic
non-small cell lung cancer and melanoma trials. To this end, the
company has a number of important milestones planned in the coming
months. We are planning to present the CLL data in detail at an
upcoming scientific conference in the fourth quarter of this year as
well as update the clinical results from our NSCLC and melanoma
trials. We also expect to announce a go/no-go decision for a Phase 3
trial in metastatic melanoma by the end of the year. By far though,
the most important near term milestone is the initiation of our Phase
3 trial in metastatic NSCLC-which is on track to be launched in the
fourth quarter of this year," concluded Kiepert.
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 five 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. Point
is currently studying talabostat in combination with docetaxel in
metastatic non-small cell lung cancer, talabostat as a single agent in
metastatic melanoma, talabostat in combination with cisplatin in
metastatic melanoma, talabostat in combination with rituximab in
advanced chronic lymphocytic leukemia and talabostat 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 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," "feels," "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 August 9, 2005 and from time to time in Point's other
reports filed with the Securities and Exchange Commission.