Allos Therapeutics Completes Patient Enrollment in Pivotal Phase 3 Study of EFAPROXYN(TM) in Women with Brain Metastases Origin
28 8월 2006 - 9:00PM
PR Newswire (US)
WESTMINSTER, Colo., Aug. 28 /PRNewswire-FirstCall/ -- Allos
Therapeutics, Inc. (NASDAQ:ALTH) today announced that it has
completed patient enrollment in its pivotal Phase 3 ENRICH study of
EFAPROXYN(TM) (efaproxiral) in women with brain metastases
originating from breast cancer. ENRICH (ENhancing whole brain
Radiation therapy In patients with breast Cancer and Hypoxic brain
metastases) is a Phase 3, randomized, open-label, multi-center
study designed to evaluate the safety and efficacy of whole brain
radiation therapy (WBRT) with supplemental oxygen with or without
EFAPROXYN in women with brain metastases from breast cancer. A
total of 360 patients were enrolled at 126 participating centers in
the United States, Canada, Europe and South America. The primary
endpoint for the study is survival. Secondary endpoints include
response rate in the brain at three months and KPS. The trial is
being conducted under a Special Protocol Assessment, which is an
agreement between the Company and the FDA that the design and
planned analyses of the study, as reflected in the trial protocol,
adequately address the objectives of the study in support of an NDA
submission. "We gratefully acknowledge the investigators and
patients who participated in this landmark study for their
important role in helping to evaluate the safety and efficacy of
EFAPROXYN in women with brain metastases originating from breast
cancer," said Paul L. Berns, President and Chief Executive Officer.
"Brain metastases are a devastating complication of breast cancer
that result in nearly uniform mortality. With the completion of
enrollment in this pivotal Phase 3 trial, we are one step closer to
introducing an important new first-in-class therapeutic option that
has the potential to improve the survival and quality of life of
this patient population." Next Milestones An independent data
monitoring committee will conduct a second planned interim analysis
of safety and efficacy data from the study at its first scheduled
meeting following the occurrence of 188 patient deaths, which is
currently expected to occur in the second half of 2006. The Company
will conduct the final analysis of safety and efficacy data
following the occurrence of 282 patient deaths, which is currently
expected to occur in mid 2007. If the trial results are positive at
either the second interim or final analysis, the Company will
submit an amendment to its previously filed new drug application as
expeditiously as possible to seek marketing approval for EFAPROXYN
for the treatment of patients with brain metastases originating
from breast cancer. About EFAPROXYN EFAPROXYN is the first
synthetic small molecule designed to sensitize hypoxic, or
oxygen-deprived, areas of tumors during radiation therapy by
facilitating the release of oxygen from hemoglobin, the
oxygen-carrying protein contained within red blood cells, and
increasing the level of oxygen in tumors. The presence of oxygen in
tumors is an essential element for the effectiveness of radiation
therapy. By increasing tumor oxygenation, the Company believes that
EFAPROXYN has the potential to enhance the efficacy of standard
radiation therapy. About Allos Therapeutics, Inc. Allos
Therapeutics, Inc. (ALTH) is a biopharmaceutical company focused on
the development and commercialization of small molecule
therapeutics for the treatment of cancer. The Company has two
product candidates in late-stage clinical development: EFAPROXYN
(efaproxiral), a radiation sensitizer currently under evaluation in
a pivotal Phase 3 trial in women with brain metastases originating
from breast cancer, and PDX (pralatrexate), a novel, next
generation antifolate currently under evaluation in a pivotal Phase
2 trial in patients with relapsed or refractory peripheral T-cell
lymphoma. The Company is also evaluating RH1, a targeted
chemotherapeutic agent, in a Phase 1 trial in patients with
advanced solid tumors. For additional information, please visit the
Company's website at http://www.allos.com/. Safe Harbor Statement
This press release contains forward-looking statements that are
made pursuant to the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995. Such forward-looking
statements include statements concerning the potential safety and
efficacy of EFAPROXYN for the treatment of patients with brain
metastases from breast cancer, the Company's projected timelines
for conducting the second interim and/or final analysis of safety
and efficacy data from the ENRICH trial, the potential of EFAPROXYN
to enhance the efficacy of standard radiation therapy, and other
statements which are other than statements of historical facts. In
some cases, you can identify forward-looking statements by
terminology such as "may," "will," "should," "expects," "intends,"
"plans," anticipates," "believes," "estimates," "predicts,"
"projects," "potential," "continue," and other similar terminology
or the negative of these terms, but their absence does not mean
that a particular statement is not forward-looking. Such
forward-looking statements are not guarantees of future performance
and are subject to risks and uncertainties that may cause actual
results to differ materially from those anticipated by the
forward-looking statements. These risks and uncertainties include,
among others: that the ENRICH trial may not demonstrate the safety
and efficacy of EFAPROXYN for the treatment of patients with brain
metastases from breast cancer; that the Company we may experience
difficulties or delays in the ENRICH trial, whether caused by
adverse events, patient death rates, regulatory issues or other
factors; and that the Company's other clinical trials may not
demonstrate the safety and efficacy of its product candidates in
their target indications. Additional information concerning these
and other factors that may cause actual results to differ
materially from those anticipated in the forward-looking statements
is contained in the "Risk Factors" section of the Company's Annual
Report on Form 10-K for the year ended December 31, 2005, and in
the Company's other periodic reports and filings with the
Securities and Exchange Commission. The Company cautions investors
not to place undue reliance on the forward-looking statements
contained in this press release. All forward-looking statements are
based on information currently available to the Company on the date
hereof, and the Company undertakes no obligation to revise or
update these forward-looking statements to reflect events or
circumstances after the date of this presentation, except as
required by law. Note: EFAPROXYN(TM) and the Allos logo are
trademarks of Allos Therapeutics, Inc. DATASOURCE: Allos
Therapeutics, Inc. CONTACT: Jennifer Neiman, Manager, Corporate
Communications of Allos Therapeutics, Inc., +1-720-540-5227, Web
site: http://www.allos.com/
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