WESTMINSTER, Colo., Dec. 12 /PRNewswire-FirstCall/ -- Allos Therapeutics,
Inc. (Nasdaq: ALTH) today announced the presentation of new findings from its
Phase 3 clinical trial of the investigational radiation sensitizer
EFAPROXYN(TM) (efaproxiral) in patients with brain metastases. Preliminary
data from the Phase 3 study, called REACH, were first announced in April 2003.
Charles Scott, Ph.D., CBS Squared, presented the findings in a poster
presentation Saturday at the 28th Annual San Antonio Breast Cancer Symposium.
In abstract #4040, titled "Improved Survival, Quality of Life (QOL), and
Quality-Adjusted Survival (QAS) in Breast Cancer Patients Treated with
Efaproxiral (EFAPROXYN(TM)) and Whole Brain Radiation Therapy (WBRT) for Brain
Metastases," Dr. Scott presented a QAS analysis of data from the Company's
Phase 3 REACH study, which compared the survival benefit of brain metastases
patients receiving EFAPROXYN with WBRT to those receiving WBRT alone. Results
of the analysis indicated that the addition of EFAPROXYN to WBRT led to a
statistically significant increase in survival for EFAPROXYN-arm patients with
brain metastases originating from breast cancer, which was accompanied by a
statistically significant improvement in both QOL and QAS, a composite measure
of quality and duration of survival. Specifically, EFAPROXYN-arm patients
with brain metastases originating from breast cancer experienced a slower
overall decline in Spitzer Quality of Life Index (SQLI) scores over time
(p<0.001) relative to the control arm. SQLI is a 5-item questionnaire with
overall score ranges from 0 (worse) to 10 (best).
"This study provides insight into the quality of life of long-term
survivors of the REACH study," said Dr. Scott. "Importantly, the survival
benefit realized by patients with brain metastases originating from breast
cancer was not clinically compromised by a decline in quality of life."
About the 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 from various solid tumors and good performance
status. Patients with small cell lung cancer, 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) alone in patients with
brain metastases. The primary endpoint of the trial was survival. Although
the difference in overall survival between patients who received EFAPROXYN
plus WBRT and patients who received WBRT alone was not statistically
significant, the trial showed a positive survival benefit among patients with
brain metastases originating from breast cancer. To further confirm the
survival benefit observed in the breast cancer sub-group, 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 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, Allos
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. Our 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. Our 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.
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.
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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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