Point Therapeutics (MM) (NASDAQ:POTP)
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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.