Allos Therapeutics, Inc. (MM) (NASDAQ:ALTH)
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Allos Therapeutics Announces Expansion of ENRICH Trial Into
Europe
WESTMINSTER, Colo., Jan. 6 /PRNewswire-FirstCall/ -- Allos Therapeutics, Inc.
(NASDAQ:ALTH) today announced the expansion into Europe of its Phase 3 trial of
the investigational radiation sensitizer EFAPROXYN(TM) (efaproxiral) in
patients with brain metastases originating from breast cancer. The Company
reported that the first ex-North American patient was enrolled yesterday in
France. To date, five investigative sites have opened for enrollment in the
EU, and another 65 ex-North American sites have committed to participate in the
study.
The Phase 3 study, known as ENRICH (ENhancing Whole Brain Radiation Therapy In
Patients with Breast Cancer and Hypoxic Brain Metastases), is designed to
compare the effect of whole brain radiation therapy with supplemental oxygen
with or without EFAPROXYN in women with brain metastases originating from
breast cancer. This randomized, open-label study will seek to enroll 360
patients at more than 100 leading medical centers in the United States, Canada,
Europe and South America. The primary endpoint of the study is median survival
time. The trial has received Special Protocol Assessment designation from the
U.S. Food and Drug Administration.
"We view the initiation of patient enrollment in Europe as an important step in
the scale up of the ENRICH trial," said Michael E. Hart, President and Chief
Executive Officer of Allos. "We're pleased with the progress made to date and
remain optimistic that we can complete enrollment by the third quarter of
2006."
About EFAPROXYN
EFAPROXYN is the first synthetic small molecule designed to "sensitize" hypoxic
(oxygen-deprived) areas of tumors prior to 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 in the treatment of cancer. By increasing tumor oxygenation
at the time of treatment, EFAPROXYN has the potential to enhance the efficacy
of standard radiation therapy. Unlike chemotherapeutics or other radiation
sensitizers, EFAPROXYN does not have to cross the blood brain barrier or enter
the tumor to be effective.
About Allos Therapeutics, Inc.
Allos Therapeutics, Inc. is a biopharmaceutical company focused on developing
and commercializing innovative drugs for improving cancer treatments. The
company's lead clinical candidate, EFAPROXYN, is a synthetic small molecule
that has the potential to sensitize hypoxic (oxygen deprived) tumor tissues and
enhance the efficacy of standard radiation therapy. In addition, Allos is
developing PDX (pralatrexate), a novel small molecule cytoxic injectable
antifolate (DHFR inhibitor) intended to treat non-small cell lung cancer,
mesothelioma and non-Hodgkin's lymphoma, as well as RH1, a targeted cytotoxic
prodrug under investigation in patients with advanced solid tumors. For more
information, please visit the company's web site 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
anticipated timing, progress and results of the ENRICH study; the potential
safety and efficacy of EFAPROXYN; 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 clinical trials may not demonstrate that EFAPROXYN
is both safe and more effective than current standards of care; that the
Company and/or its collaborators may not be able to enroll sufficient numbers
of patients in the ENRICH study in the expected timeframe; that the safety
and/or efficacy results of the ENRICH will not support an application for
marketing approval for EFAPROXYN in the United States or any other country; and
the risk that the Company may lack the financial resources and access to
capital to fund future clinical trials for EFAPROXYN or any of its other
product candidates. 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, 2003,
as amended, and in the Company's other periodic reports and filings with the
Securities and Exchange Commission, including its Quarterly Report on Form 10-Q
for the quarter ended September 30, 2004. 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, +1-720-540-5227,
Web site: http://www.allos.com/