Point Therapeutics Advances Third Phase 2 Oncology Study in Talabostat; Chronic Lymphocytic Leukemia Trial Moves to the Second S
September 19 2005 - 6:30AM
Business Wire
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.
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