WESTMINSTER, Colo., Oct. 11 /PRNewswire-FirstCall/ -- Allos Therapeutics,
Inc. (Nasdaq: ALTH) today announced that it has withdrawn its European
Marketing Authorization Application (MAA) for its investigational radiation
sensitizer REVAPROXYN(TM) (efaproxiral, EFAPROXYN(TM) in the United States)
for use as an adjunct to whole brain radiation therapy (WBRT) for the
treatment of patients with brain metastases originating from breast cancer.
The Company made this decision as a result of the Rapporteurs' Day 180 Joint
Assessment Report, which concluded that the current data package was not
sufficient to support approval. The MAA was based upon the results of the
Company's Phase 3 REACH trial, which demonstrated a statistically significant
survival benefit in patients with brain metastases originating from breast
cancer, a subgroup of patients that was not prospectively defined as an
intent-to-treat subgroup.
"We are disappointed that withdrawal of the MAA is necessary at this
time," said Michael E. Hart, President and Chief Executive Officer of Allos.
"However, we were able to address many of the CHMP's questions and concerns
regarding REVAPROXYN and believe that our on-going ENRICH trial, if positive,
together with the other supporting data, should allow us to address the CHMP's
remaining concerns and provide the additional data necessary to support the
future approval of REVAPROXYN for marketing in Europe. Furthermore, the
withdrawal of the MAA in Europe does not affect the status of our New Drug
Application for EFAPROXYN in the United States and we remain committed to
completing the ENRICH study as expeditiously as possible."
In June 2004, the Company received an approvable letter from the U.S. Food
and Drug Administration (FDA) for its New Drug Application to market EFAPROXYN
for the treatment of patients with brain metastases originating from breast
cancer. The key contingency identified in the approvable letter is the
successful completion of an additional clinical trial providing sufficient
evidence to confirm the positive survival benefit observed in the breast
cancer subset in the Phase 3 REACH trial. The Company's on-going ENRICH
trial, initiated in February 2004, is designed to generate data that, if
positive, would satisfy FDA's requirement for confirmation of the REACH trial
results. The ENRICH study currently has more than 100 out of 125 planned
investigative sites open for enrollment. The Company currently expects to
complete patient enrollment in this trial in the second half of 2006 and
report preliminary results approximately six months thereafter.
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. (Nasdaq: ALTH) is a biopharmaceutical company
focused on developing and commercializing innovative small molecule
therapeutics for the treatment of cancer. The Company's lead product
candidate, EFAPROXYN, is a synthetic small molecule designed to sensitize
hypoxic, or oxygen-deprived, tumor tissue during radiation therapy. EFAPROXYN
is currently being evaluated as an adjunct to whole brain radiation therapy in
a pivotal Phase 3 trial in women with brain metastases originating from breast
cancer. The Company's other product candidates are: PDX (pralatrexate), a
small molecule chemotherapeutic agent (DHFR inhibitor) currently under
investigation as both a single agent and in combination therapy regimens in
patients with non-small cell lung cancer and Non-Hodgkin's lymphoma; and RH1,
a small molecule chemotherapeutic agent bioactivated by the enzyme
DT-diaphorase currently under evaluation in patients with advanced solid
tumors. For more information, 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 potential for the ENRICH trial to provide the additional data
necessary to support approval of REVAPROXYN for marketing in Europe; our
projected timelines for completion of enrollment and announcement of the
results of the ENRICH trial, 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 we may experience
difficulties or delays in the ENRICH trial, whether caused by adverse events,
investigative site initiation rates, patient enrollment rates, regulatory
issues or other factors; that the results of the ENRICH trial and other
supporting information may not be sufficient to support the approval of
REVAPROXYN by the European Medicines Agency, the FDA, or any other regulatory
authority; and risks related to the regulatory approval process in general.
In particular, there can be no assurance that the data generated by the ENRICH
trial will demonstrate a statistically significant survival benefit or that we
will be able to satisfactorily address questions and concerns raised by any
regulatory agency. 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, 2004,
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.
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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