Point Therapeutics (MM) (NASDAQ:POTP)
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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.