Interim Analysis Supports Continuation of Allos Therapeutics' Pivotal Phase 3 Trial
04 4월 2006 - 9:00PM
PR Newswire (US)
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.
DATASOURCE: Allos Therapeutics, Inc. CONTACT: Jennifer Neiman
Manager, Corporate Communications, Allos Therapeutics, Inc.,
+1-720-540-5227, Web site: http://www.allos.com/
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