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.
SOURCE Allos Therapeutics, Inc.
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Related links:
http://www.allos.com
CONTACT:
Jennifer Neiman, Manager, Corporate
Communications of Allos Therapeutics, Inc., +1-720-540-5227,
jneiman@allos.com
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