Allos Therapeutics Announces Expansion of ENRICH Trial Into Europe
January 06 2005 - 8:01AM
PR Newswire (US)
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/
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