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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.
SOURCE Allos Therapeutics, Inc.
Web Site: http://www.allos.com