Results Published in Journal of Clinical Oncology Affirm Survival Benefit of EFAPROXYN(TM) in Patients with Brain Metastases Ori
03 1월 2006 - 10:00PM
PR Newswire (US)
WESTMINSTER, Colo., Jan. 3 /PRNewswire-FirstCall/ -- Allos
Therapeutics, Inc. (NASDAQ:ALTH) today announced the publication of
results from its Phase 3 REACH study of EFAPROXYN (efaproxiral) in
patients with brain metastases. Results of the study, which were
reported in the January 1st edition of the Journal of Clinical
Oncology (volume 24, issue 1), suggest that the addition of
EFAPROXYN to whole brain radiation therapy (WBRT) may improve
survival and response rates in patients with brain metastases,
particularly those from breast cancer. Authors of the manuscript
analyzed data from the REACH study to assess the safety and
efficacy of EFAPROXYN when administered as an adjunct to WBRT in
patients with brain metastases from various solid tumors. Among the
subgroup of 397 patients with non-small cell lung cancer (NSCLC) or
breast cancer, results of the analysis indicated that there was an
improvement in both response rate and median survival time for
patients in the EFAPROXYN arm. Median survival time (MST) for the
NSCLC/breast cancer subgroup was 6.0 months for the EFAPROXYN arm
versus 4.4 months in the control arm (HR=0.82, p=0.07), an
improvement of 38%. A Cox multiple regression analysis conducted to
account for known predictors of survival in this heterogeneous
patient population demonstrated a 25% reduction in the risk of
death (HR=0.75, 95% CI: 0.60, 0.94; p=0.01) for patients in the
EFAPROXYN arm. A statistically significant improvement (13%,
p=0.01) in response rate (radiographic complete plus partial
response) was also observed for patients in the EFAPROXYN arm in
the NSCLC/breast cancer subgroup. In an exploratory analysis by
primary tumor type, the largest EFAPROXYN treatment effect was
observed in the 107 eligible patients with brain metastases
originating from breast cancer (HR=0.51, p=0.003, unadjusted
log-rank). Overall, EFAPROXYN was very well tolerated, with the
majority of EFAPROXYN-related adverse events being grade 1 and 2.
All adverse events were resolved within the 1-month follow-up
period and were easily managed with supportive care. A portion of
these data were previously presented at the 40th Annual Meeting of
the American Society of Clinical Oncology, the 26th Annual San
Antonio Breast Cancer Symposium and the 8th Annual Scientific
Meeting of the Society for Neuro-Oncology. "Our findings suggest
that EFAPROXYN has the potential to improve the survival of a group
of patients with an otherwise very poor prognosis," said John H.
Suh, M.D., Director of the Gamma Knife Center, Radiation Oncology,
Brain Tumor Institute at the Cleveland Clinic Foundation and the
study's principal investigator. "Results of this study are
particularly compelling in light of the lack of progress made by
the field over the past 25 years in extending the survival and
quality of life of this patient population." To further confirm the
survival benefit observed in the breast cancer subgroup in the
REACH trial, in February 2004, the Company initiated a Phase 3,
randomized, open-label, multi-center trial called ENRICH (Enhancing
Whole Brain Radiation Therapy In Patients with Breast Cancer and
Hypoxic Brain Metastases), designed to compare the effect of WBRT
with supplemental oxygen with or without EFAPROXYN in women with
brain metastases from breast cancer. The Company currently expects
to complete patient enrollment in the ENRICH trial during the
second half of 2006 and report preliminary results approximately
six months thereafter. About the REACH study The REACH study was a
randomized, open label Phase 3 clinical trial designed to
demonstrate the safety and efficacy of EFAPROXYN in treating
patients with brain metastases. Patients with SCLC, germ cell
tumors or lymphoma were excluded. Prior brain tumor resection was
allowed as long as measurable lesion(s) remained. The study
enrolled 538 patients and compared the safety and efficacy of
EFAPROXYN plus WBRT and supplemental oxygen (271 patients) versus
WBRT and supplemental oxygen (267 patients) in patients with brain
metastases. Radiographic imaging of the brain (MRI or CT) was
required at baseline, 1-month post WBRT, 3-months post-WBRT and
every three months thereafter until progression or death. The
primary endpoint of the trial was survival. Response rate in the
brain was evaluated as a secondary endpoint. 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 safety and efficacy of EFAPROXYN for the
treatment of patients with brain metastases from breast cancer or
any other type of cancer, our projected timelines for completion of
enrollment and announcement of the results of the ENRICH trial, 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 our
clinical trials, whether caused by adverse events, investigative
site initiation rates, patient enrollment rates, regulatory issues
or other factors: and that clinical trials may not demonstrate the
safety and efficacy of our product candidates in their target
indications. 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. 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, Inc., +1-720-540-5227, Web site:
http://www.allos.com/
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