- Independent Data Monitoring Committee Recommends ENRICH Trial Continue to
Final Efficacy Analysis -
WESTMINSTER, Colo., Oct. 23 /PRNewswire-FirstCall/ -- Allos
Therapeutics, Inc. (Nasdaq: ALTH) today announced that an independent data
monitoring committee (DMC) has completed a second planned interim analysis
of data from the Company's pivotal Phase 3 ENRICH trial of EFAPROXYN(TM)
(efaproxiral) plus whole brain radiation therapy (WBRT) in women with brain
metastases originating from breast cancer, and has recommended that the
trial continue to the final efficacy analysis. The interim analysis was
triggered by the occurrence of 188 patient deaths and was based upon an
evaluation of patients randomized through July 31, 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.
"This recommendation represents continued progress toward the
completion of the ENRICH trial and further confirmation of EFAPROXYN's
favorable safety profile," said Paul Berns, Allos' President and Chief
Executive Officer. "We are grateful for the support received from our
investigators, patients and employees who enabled us to reach this
milestone, and look forward to conducting the final efficacy analysis
following the occurrence of 282 patient deaths, which we currently expect
to occur in mid-2007."
The Phase 3 ENRICH trial (ENhancing whole brain Radiation therapy In
patients with breast Cancer and Hypoxic brain metastases) is a randomized,
open-label, multi-center study designed to evaluate the safety and efficacy
of WBRT with supplemental oxygen with or without EFAPROXYN in women with
brain metastases originating from breast cancer. Patient enrollment in the
trial was completed in August 2006, with a total of 368 patients enrolled
at 78 medical centers in the United States, Canada, Europe and South
America. The primary endpoint of the trial is survival. Secondary endpoints
include response rate in the brain at three months, Karnofsky Performance
Status, and neurologic signs and symptoms assessment. The trial is being
conducted under a Special Protocol Assessment, which is an agreement
between the Company and the U.S. Food and Drug Administration (FDA) that
the design and planned analyses of the study, as reflected in the trial
protocol, adequately address the objectives of the study in support of a
new drug application.
Next Milestones
The Company will conduct the final analysis of safety and efficacy data
from the ENRICH trial following the occurrence of 282 patient deaths, which
is currently expected to occur in mid-2007. If the trial is deemed to be
positive at the final analysis, the Company intends to submit an amendment
to its previously filed new drug application (NDA) to the FDA 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 Brain Metastases Originating from Breast Cancer
According to the American Cancer Society, brain metastases occur in
approximately 175,000 patients per year in the United States. WBRT is the
current standard of care for the treatment of brain metastases, and is
administered to approximately 125,000 patients per year in the United
States as a means to prevent or reduce complications and extend survival.
Cancers that metastasize to the brain most often originate in the breast,
lungs, kidneys or melanoma in the skin. Breast cancer is the second most
common cause of brain metastases, accounting for 15% to 20% of the total
incidence of brain metastases. The median survival of women with brain
metastases originating from breast cancer who receive WBRT is approximately
4.6 months.
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, EFAPROXYN has the potential to enhance the efficacy of
standard radiation therapy.
Based on the findings from a prior Phase 3 trial of EFAPROXYN in
patients with brain metastases, in December 2003 the Company submitted an
NDA to the FDA to seek approval to market EFAPROXYN in the United States as
an adjunct to WBRT for the treatment of patients with brain metastases from
breast cancer. In June 2004, the FDA issued an "approvable letter" in which
it indicated that the NDA may be approved if the Company successfully
completes the ENRICH trial and submits the results as an NDA amendment for
the FDA's review.
EFAPROXYN Safety Profile
EFAPROXYN has a well established safety profile. To date, approximately
900 patients have been treated with EFAPROXYN in conjunction with radiation
therapy in 12 clinical trials, including ENRICH. The results have shown
that EFAPROXYN is generally well tolerated and has an acceptable safety
profile for use in cancer patients. Adverse events observed to date in the
ENRICH study appear to be similar to those observed in previous clinical
trials with EFAPROXYN.
About Allos Therapeutics, Inc.
Allos Therapeutics, Inc. (ALTH) is a biopharmaceutical company focused
on the development and commercialization of small molecule therapeutics for
the treatment of cancer. The Company has two product candidates in
late-stage clinical development: EFAPROXYN (efaproxiral), a radiation
sensitizer currently under evaluation in a pivotal Phase 3 trial in women
with brain metastases originating from breast cancer, and PDX
(pralatrexate), a novel, next generation antifolate currently under
evaluation in a pivotal Phase 2 trial in patients with relapsed or
refractory peripheral T-cell lymphoma. The Company is also evaluating RH1,
a targeted chemotherapeutic agent, in a Phase 1 trial in patients with
advanced solid tumors. For additional information, please visit the
Company's website 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 Company's projected timeline for conducting the final
analysis of safety and efficacy data from the ENRICH trial, the Company's
intent to submit an amendment to its previously filed NDA if the ENRICH
trial is deemed to be positive at the final analysis, 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 adverse
events, 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 of Allos Therapeutics, +1-720-540-5227,
jneiman@allos.com
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