Talabostat Phase 2 Non-Small Cell Lung Cancer Trial Featured at the 14th International Conference on Gene Therapy of Cancer
September 18 2006 - 7:30AM
Business Wire
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.
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