Allos Therapeutics Announces Withdrawal of European Marketing Authorization Application for REVAPROXYN(TM)
October 11 2005 - 5:06PM
PR Newswire (US)
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withdrawn its European Marketing Authorization Application (MAA)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. 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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