Point Therapeutics Receives Fast Track Designation for Talabostat
June 01 2006 - 7:00AM
Business Wire
Point Therapeutics, Inc. (NASDAQ: POTP) today announced that the
U.S. Food and Drug Administration (FDA) has granted talabostat Fast
Track Designation for the treatment of Stage IIIB/IV non-small cell
lung cancer (NSCLC) patients who have failed prior platinum-based
chemotherapy. "The Fast Track designation is a significant
milestone for talabostat and an important step in moving forward
with the development process. The designation recognizes the
serious unmet medical need of patients with metastatic non-small
cell lung cancer who have failed prior platinum-based chemotherapy
and the potential of talabostat to impact this disease," said Dr.
Margaret Uprichard, Senior Vice President and Chief Scientific
Office of Point Therapeutics. "This designation will allow for
rolling submission of our potential New Drug Application (NDA) for
talabostat--which means that sections of the NDA can be submitted
and reviewed by the FDA on an ongoing basis prior to their receipt
of the complete NDA." Talabostat's novel dual mechanism of action
and positive results from the Phase 2 study combining talabostat
with docetaxel (64% second-line patients and 36% third-line
patients) were the key components of the application for Fast Track
designation in metastatic NSCLC. In the Phase 2 study, 55 patients
were enrolled--42 of whom met evaluability criteria for response.
Six patients demonstrated a clinical response to treatment as
defined by World Health Organization criteria (a 50% or greater
reduction in tumor size) for an overall response rate of 14.3%. Two
of these patients had a complete response, defined as a complete
disappearance of their tumor. In all 55 patients, median
progression-free survival is 4.2 months and one year survival is
38%. Under the FDA Modernization Act of 1997, the Fast Track
program of the FDA is designed to facilitate the development and
expedite the review of a new drug that is intended for the
treatment of a serious or a life-threatening condition, and
demonstrates the potential of a drug candidate to address unmet
medical needs for such a condition. Under the FDA Guidance, drugs
that are granted Fast Track status typically represent a
significant improvement in the safety or effectiveness over
existing therapies. Point's Phase 3 NSCLC program was initiated in
October 2005 and consists 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, evaluating the
combination of talabostat with docetaxel versus placebo and
docetaxel opened to enrollment in October 2005. The second
400-patient trial, evaluating the combination of talabostat with
pemetrexed versus placebo and pemetrexed opened to enrollment in
February 2006. The primary study endpoint is progression-free
survival. Secondary endpoints include overall survival, objective
response rate, duration of response and quality of life. Trial
results for both studies are projected for late 2007. About Lung
Cancer: 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. Nearly 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 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.
Point Therapeutics (MM) (NASDAQ:POTP)
Historical Stock Chart
From Jun 2024 to Jul 2024
Point Therapeutics (MM) (NASDAQ:POTP)
Historical Stock Chart
From Jul 2023 to Jul 2024