Point Therapeutics (MM) (NASDAQ:POTP)
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Point Therapeutics, Inc. (NASDAQ:POTP) announced
positive interim results today in the Company's Phase 2 single-agent
and combination studies of talabostat in patients with Stage IV
melanoma. This announcement updates results released this morning in
two abstracts at the American Society of Clinical Oncology Annual
Meeting in Orlando, FL.
In the single agent trial, 18 patients with metastatic melanoma
have been evaluated to date. Two patients had a tumor response to
talabostat as defined by RECIST, at least a 30% reduction in tumor
size, with one of these patients experiencing a complete response,
defined as a complete disappearance of their tumor. The most common
adverse events were edema, fatigue, nausea, and muscle and joint pain,
all of which have been generally manageable and reversible.
"I am excited to see two responders out of the first 18 evaluable
patients in this study. It is unusual for advanced melanoma patients
to respond to new single-agent therapies, which gives us cause to be
optimistic about the potential of talabostat as a treatment option for
this disease," said Dr. Thomas Gajewski, a lead investigator in the
study at the University of Chicago Medical Center and a member of
Point's Clinical Advisory Board.
In the second study in patients with metastatic melanoma,
talabostat is administered in combination with cisplatin. Out of 15
evaluable patients to date, two patients have had a response of at
least a 30% reduction in tumor size. The most common adverse events
were nausea, fatigue and vomiting, which are consistent with cisplatin
treatment.
"The positive results to date, particularly in our single agent
study, will allow us to proceed with the completion of our Phase 2
clinical studies in metastatic melanoma. The combination study with
cisplatin has had a substantially greater incidence of nausea and
vomiting than the single-agent study. Since talabostat is an oral
medication, the nausea and vomiting impact patient compliance. This,
in turn, has led to a higher number of unevaluable patients in this
particular study," said Dr. Maggie Uprichard, Senior Vice President
and Chief Development Officer at Point. "As a result, we have changed
our protocol and are encouraging study sites to pre-medicate patients
with anti-emetic medications. We will continue to enroll and evaluate
patients in the combination trial and expect enrollment in both
studies to be completed by the end of 2005. With continued supportive
clinical results, our goal is to be in a position in the first half of
2006 to initiate a Phase 3 program with talabostat in metastatic
melanoma," added Dr. Uprichard.
Both studies are open-label, single-arm trials in patients with
advanced metastatic melanoma using the Simon 2-stage design. The
primary endpoint in both studies is objective response rate. In the
single agent study, secondary endpoints include survival, duration of
response, complete response, time to progression and cytokine
expression in serum and biopsy tissue. In the combination study with
cisplatin, secondary endpoints include survival, duration of response,
time to progression, complete response and incidence of
clinically-significant events of neutropenia or anemia.
Data from Point's Phase 2 combination trial of talabostat with
docetaxel in advanced non-small cell lung cancer (NSCLC) will be
presented in a poster session at the American Society of Clinical
Oncology Annual Meeting, Tuesday, May 17 at 8:00 a.m.
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Upcoming Milestones:
Talabostat Trials Clinical Development Milestones Target Date
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Pancreatic Cancer Initiation of Phase 2 Q2 2005
w/gemcitabine
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CLL w/rituximab Interim Phase 2 go/no-go Q3 2005
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NSCLC w/docetaxel Initiation of Phase 3 Q4 2005
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Melanoma Phase 3 go/no-go Q4 2005
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About Point Therapeutics, Inc.:
Point is a Boston-based biopharmaceutical company developing a
family of dipeptidyl peptidase (DPP) inhibitors for a variety of
cancers, certain hematopoietic disorders, type 2 diabetes and as
vaccine adjuvants. Its lead product candidate, talabostat (PT-100), is
a small molecule drug in 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 accelerate
the reconstitution of the hematopoietic system. In 2004, Point
initiated four Phase 2 clinical trials of talabostat. The trials are
studying talabostat in combination with Taxotere(R) for the treatment
of advanced NSCLC, talabostat as a single agent to treat metastatic
melanoma, talabostat in combination with cisplatin also to treat
advanced metastatic melanoma, and talabostat in combination with
rituximab to treat advanced chronic lymphocytic leukemia (CLL). The
Company is also studying talabostat in clinical trials to potentially
prevent both neutropenia and anemia. 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," "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 10-Q, filed with the Securities and
Exchange Commission on May 10, 2005, and from time to time in Point's
other reports filed with the Securities and Exchange Commission.