Response at Three-Months Post WBRT Found to be Statistically Significant Predictor of Survival in Largest Ever Randomized Study
05 Octobre 2004 - 11:30PM
PR Newswire (US)
Response at Three-Months Post WBRT Found to be Statistically
Significant Predictor of Survival in Largest Ever Randomized Study
of Patients With Brain Metastases ATLANTA, Oct. 5 /PRNewswire/ --
For brain metastases patients undergoing whole brain radiation
therapy (WBRT), radiographic response in the brain at three months
is a statistically significant predictor of prolonged survival,
according to study results presented today at the 46th Annual
Meeting of the American Society for Therapeutic Radiation Oncology.
The findings were drawn from Allos Therapeutics' completed 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. Dino B. Stea, M.D., Ph.D., Director,
Radiation Oncology, Arizona Cancer Center and the study's lead
enroller presented the results in abstract #2126, titled "Response
at 3 Months After Whole Brain Radiation Therapy Predicts Survival
in Brain Metastases Patients." Dr. Stea and colleagues conducted a
retrospective analysis of the results from the REACH study to
assess the validity of using response (complete or partial) in the
brain after WBRT to predict subsequent survival in brain metastases
patients. Results of the analysis indicated that response in the
brain post WBRT (greater than or equal to 50% reduction in overall
brain tumor size) at 90 days, as assessed by an independent central
review, was a statistically significant predictor of survival
compared to non-responders (HR=0.63, p=0.004). Response at one
month was not found to be a statistically significant predictor of
subsequent survival. Moreover, the results demonstrated a
statistically significant improvement in response rate at three
months for patients in the EFAPROXYN arm vs. control arm patients
(28% vs. 20%, respectively; p=0.036). "Our findings have
significant implications for the design of future studies of
patients with brain metastases and good performance status," said
Dr. Stea. "This study affirms the validity of using a WBRT imaging
assessment at three months to predict prolonged subsequent survival
in brain metastases patients." Results from Dr. Stea's
retrospective analysis were incorporated into the study design of
Allos' 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
trial, which was initiated in February 2004, incorporated Dr.
Stea's suggested follow-up time points into the design. Study
Design 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 and good
performance status. 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 two 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
(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 in the treatment of cancer. By increasing tumor oxygenation
at the time of treatment, EFAPROXYN has the potential to enhance
the efficacy of standard radiation therapy. Unlike
chemotherapeutics or other radiation sensitizers, EFAPROXYN does
not have to cross the blood brain barrier or enter the tumor to be
effective. About Allos Therapeutics, Inc. Allos Therapeutics, Inc.
is a biopharmaceutical company focused on developing and
commercializing innovative drugs for improving cancer treatments.
The company's lead clinical candidate, EFAPROXYN, is a synthetic
small molecule that has the potential to sensitize hypoxic (oxygen
deprived) tumor tissues and enhance the efficacy of standard
radiation therapy. In addition, Allos is developing PDX
(pralatrexate), a novel small molecule cytoxic injectable
antifolate (DHFR inhibitor) intended to treat non-small cell lung
cancer, mesothelioma and non-Hodgkin's lymphoma. For more
information, please visit the company's web site at:
http://www.allos.com/. Safe Harbor Statement This announcement
contains forward-looking statements that involve risks and
uncertainties. Future events may differ materially from those
discussed herein due to a number of factors, including, but not
limited to, risks and uncertainties related to the Company's
ability to adequately demonstrate the safety and efficacy of
EFAPROXYN for use as an adjunct to WBRT for the treatment of
patients with brain metastases from breast cancer or any other
solid tumor, and to obtain regulatory approval to market EFAPROXYN
for this or any other indication, as well other risks and
uncertainties detailed from time to time in the Company's SEC
filings, including its Annual Report on Form 10-K, as amended, for
the year ended December 31, 2003. [The company's product candidates
are in various stages of development and may never be fully
developed in a manner suitable for commercialization. If the
company does not develop commercially successful products, its
ability to generate revenue will be limited. If the company is
unable to raise additional capital when required or on acceptable
terms, it may have to significantly delay, scale back or
discontinue one or more of its drug development programs. Delays in
clinical trials, whether caused by adverse events, patient
enrollment rates, regulatory issues or other factors, could
adversely affect the company's financial position and prospects.
Results from earlier clinical trials are not necessarily predictive
of future clinical results. If the company is unable to generate
meaningful amounts of revenue or cannot otherwise raise the
necessary funds to support operations, it may not be able to
continue as a going concern.] 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 assumes no responsibility to update such
statements. DATASOURCE: Allos Therapeutics, Inc. CONTACT: Jennifer
Neiman, Manager, Corporate Communications of Allos Therapeutics,
+1-720-540-5227, or cell, +1-303-518-4114, Web site:
http://www.allos.com/
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