Allos Therapeutics Announces ENRICH Trial Update
23 Outubro 2006 - 8:29AM
PR Newswire (US)
- 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. DATASOURCE: Allos Therapeutics, Inc. CONTACT:
Jennifer Neiman Manager, Corporate Communications of Allos
Therapeutics, +1-720-540-5227, Web site: http://www.allos.com/
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