WESTMINSTER, Colo., April 4 /PRNewswire-FirstCall/ -- Allos
Therapeutics, Inc. (Nasdaq: ALTH) today announced that an independent data
monitoring committee (DMC) has completed a planned interim analysis of data
from the Company's Phase 3 ENRICH trial with EFAPROXYN(TM) (efaproxiral)
and has recommended that the trial continue per the protocol. This interim
review was triggered by the occurrence of 94 patient deaths and was based
upon an evaluation of patients randomized through February 14, 2006. In
order to protect the integrity of the trial, the results of the efficacy
analysis will not be made available to the Company until the study is
completed. No major patient safety concerns were identified by the DMC.
ENRICH is a randomized, open-label, multi-center trial 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. The trial is expected to enroll 360 patients at up to
125 sites worldwide. The primary endpoint of the trial is survival.
"This recommendation represents continued progress toward the
completion of patient enrollment in ENRICH and further validation of
EFAPROXYN's favorable safety profile," said Paul L. Berns, President and
Chief Executive Officer of Allos. "We are pleased with the DMC's
recommendation and are grateful for the support received from investigators
and patients who enabled us to reach this milestone."
Next Milestones
In accordance with the protocol's statistical analysis plan, the DMC
will conduct a second interim analysis of safety and efficacy data
following the occurrence of 188 patient deaths, which is currently expected
to occur in the second half of 2006. If necessary, 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 the first half
of 2007. If the trial is deemed to be positive at either the second interim
or final analysis the Company will submit an amendment to its previously
filed new drug application to seek marketing approval for EFAPROXYN for use
as an adjunct to radiation therapy for the treatment of brain metastases
originating from breast cancer.
About the Data Monitoring Committee
The DMC is comprised of independent medical experts and statisticians
and was established by Allos as part of the Company's compliance with good
clinical practice guidelines. The DMC is responsible for monitoring the
safety of patients participating in the ENRICH trial and for conducting
interim analyses of trial results to assess the safety and efficacy of
EFAPROXYN.
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(TM) (efaproxiral), 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, please visit the Company's web site at: http://www.allos.com.
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.
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 Company's projected timelines relating to the ENRICH trial,
the potential safety and efficacy of EFAPROXYN for the treatment of
patients with brain metastases originating from breast cancer, 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 Company may
experience difficulties or delays in the ENRICH trial, whether caused by
competition, adverse events, patient enrollment rates, regulatory issues or
other factors; and that the ENRICH trial may not demonstrate the safety and
efficacy of EFAPROXYN for the treatment of brain metastases from breast
cancer. Even if the ENRICH trial demonstrates the safety and efficacy of
EFAPROXYN, regulatory authorities may not approve EFAPROXYN for the
treatment of patients with brain metastases originating from breast cancer,
the Company may not be able to successfully market EFAPROXYN, or the
Company may face post-approval problems that require the withdrawal of
EFAPROXYN from the market. 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, Allos Therapeutics, Inc., +1-720-540-5227,
jneiman@allos.com
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