Point Therapeutics Announces Positive Results in Phase 2 Metastatic Melanoma Program
14 May 2005 - 10:00PM
Business Wire
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. -0- *T 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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*T 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.
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