Point Therapeutics (MM) (NASDAQ:POTP)
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Point Therapeutics, Inc. (NASDAQ: POTP) announced today
that talabostat's Phase 2 non-small cell lung cancer (NSCLC) program
and dual mechanism of action was presented on Saturday, September 16,
2006 at the 14th International Conference on Gene Therapy of Cancer in
Dallas, Texas. Dr. Casey Cunningham, an oncologist at Mary Crowley
Research Center in Dallas, Texas and a member of Point's Clinical
Advisory Board, presented a summary of the Phase 2 NSCLC trial
results. Dr. Barry Jones, Point's Senior Vice President and Chief
Scientific Officer, presented an overview of talabostat's novel dual
mechanism of action, emphasizing the pathway of immune stimulation.
"While talabostat does not fit into the category of gene therapy,
it does offer an innovative approach as a potential anti-cancer agent.
Identifying and featuring these new approaches is the major focus of
our event. Talabostat's mechanism of action is extremely interesting
and with the positive results we saw in the Phase 2 non-small cell
lung cancer trial, we thought this was a nice opportunity to introduce
talabostat to a wider audience," explained Dr. Casey Cunningham.
Point launched two Phase 3 trials in metastatic NSCLC based on
positive data in the Phase 2 trial. In the Phase 2 study combining
talabostat with docetaxel, the total number of observed clinical
responses was six, for an overall response rate of 14.3%. Of the six
responding patients, two experienced complete responses. In addition,
38% of the patients enrolled in the trial survived at least one-year.
Point's Phase 3 program evaluates talabostat, in patients with
Stage IIIB/IV NSCLC after failure of a platinum-based chemotherapy.
The program consists of two randomized, double-blind,
placebo-controlled trials in up to 800 patients at approximately 100
sites in North America. Both trials are currently open to enrollment.
The first trial evaluates talabostat in combination with docetaxel
(Taxotere(R); Sanofi-Aventis) versus docetaxel with placebo. The
second trial evaluates talabostat in combination with pemetrexed
(Alimta(R); Eli Lilly) versus pemetrexed with placebo. Docetaxel and
pemetrexed are the current standards 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. Results
from both trials are expected in the fourth quarter of 2007.
Talabostat is an oral, targeted agent, which is currently in
clinical development for potential use in oncology. In addition to the
NSCLC Phase 3 trials, talabostat is being evaluated in Phase 2 studies
to treat chronic lymphocytic leukemia, pancreatic cancer and
metastatic melanoma.
Talabostat is a known dipeptidyl peptidase (DPP) inhibitor. DPPs
are enzymes that appear to regulate several different physiological
processes including those involved in tumor growth and host responses
to cancer, type 2 diabetes, and immune responses to vaccines. The
Company believes that talabostat employs a novel dual mechanism of
action by (1) targeting a DPP called fibroblast activation protein
(FAP) that is uniquely expressed in the tumor stroma, or connective
tissue of the tumor, while (2) concurrently stimulating the immune
system through the inhibition of DPP 8 and 9, enabling the body to
promote its natural ability to attack tumors.
Certain statements contained herein are not strictly historical
and are "forward looking" statements as defined in the Private
Securities Litigation Reform Act of 1995. These statements include,
without limitation, 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," "projects," "should," "seeks,"
"plans," "schedules 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 the risk factors described in Point's quarterly report on
Form 10-Q, filed with the Securities and Exchange Commission on August
9, 2006, and from time to time in Point's other reports filed with the
Securities and Exchange Commission.