Point Therapeutics Initiates Phase 3 Program in Metastatic Non-Small Cell Lung Cancer
October 13 2005 - 4:38PM
Business Wire
Point Therapeutics, Inc. (NASDAQ: POTP) announced today that it
initiated its Phase 3 program in metastatic non-small cell lung
cancer (NSCLC). This news follows a successful End-of-Phase 2
meeting with the Food and Drug Administration. "We are pleased with
our End-of-Phase 2 meeting discussions with the FDA and the fact
that there were no major changes to the Phase 3 study protocols. We
look forward to continuing to clinically develop talabostat in this
advanced lung cancer population," said Dr. Margaret Uprichard,
Chief Development Officer and Senior Vice President of Point
Therapeutics. Point's Phase 3 program will further evaluate the
company's lead compound, talabostat, in patients with Stage IIIB/IV
NSCLC after failure of a platinum-based chemotherapy. The program
will consist of two randomized, double-blind, placebo-controlled
trials in up to 800 patients at approximately 100 sites in North
America. The first 400-patient trial has opened to enrollment. This
trial will evaluate talabostat in combination with docetaxel versus
docetaxel with placebo. The second 400-patient trial will evaluate
talabostat in combination with pemetrexed versus pemetrexed with
placebo. Docetaxel and pemetrexed are the current standard of care
in this advanced patient population. The primary study endpoint is
progression-free survival. Secondary endpoints include overall
survival, objective response rate, complete response, duration of
response and quality of life. "I am encouraged by the positive
results in Point's Phase 2 trial of talabostat and docetaxel. As
reported at this year's ASCO meeting, five patients demonstrated at
least a 50% reduction in tumor size--of which two had a complete
response, defined as a complete disappearance of their tumor. To
see complete responders in a second or third line setting in
advanced non-small cell lung cancer is rare and merits further
study," said Dr. Casey Cunningham, an oncologist at Mary Crowley
Medical Research Center in Dallas, TX and a member of Point's
Clinical Advisory Board. "Talabostat has the potential to become an
important treatment for non-small cell lung cancer and the
initiation of Point's Phase 3 program is a significant step towards
achieving this goal," concluded Dr. Cunningham. "Initiating our
Phase 3 registration program in non-small cell lung cancer is an
important milestone for the company. This program, if successfully
completed, is expected to be the basis of our first registration
package with the regulatory authorities," said Don Kiepert,
President and CEO of Point Therapeutics, Inc. "Talabostat has
several characteristics that make it an attractive drug
candidate-it is orally available and has the potential to be used
in both solid and hematologic malignancies and in combination with
a range of chemotherapies, monoclonal antibodies and other forms of
cancer treatment," added Kiepert. "We are very excited to begin our
Phase 3 program in a serious disease where a need for more
treatment options exists." According to the American Cancer
Society, lung cancer is the leading cause of cancer death among men
and women in the United States--with nearly 60% of people diagnosed
dying within one year and nearly 75% dying within two years. 87% of
all lung cancers are non-small cell. While treatment options for
NSCLC continue to emerge, mortality rates have not improved in the
last 10 years, leaving a significant need for advancement in
current therapies. 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 several 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, 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 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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