Allos Therapeutics, Inc. (MM) (NASDAQ:ALTH)
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Prognostic Factors Influencing Survival in Patients with Brain
Metastases Identified in Largest Ever Randomized Study
ATLANTA, Oct. 4 /PRNewswire-FirstCall/ -- Allos Therapeutics, Inc.
(NASDAQ:ALTH) 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. A retrospective analysis of
the results from the study led to the identification of the strongest
prognostic factors for survival in patients with brain metastases. John H.
Suh, M.D., Clinical Director, Radiation Oncology, Brain Tumor Institute at the
Cleveland Clinic Foundation and the study's lead investigator presented the
findings in an oral presentation today at the 46th Annual Meeting of the
American Society for Therapeutic Radiation Oncology. Preliminary data from the
Phase 3 study, called REACH, were first announced in April 2003.
In abstract #60, titled "Prognostic Factors for Survival in Patients with Brain
Metastases Enrolled on a Worldwide Phase 3 Randomized Trial of 538 Patients,"
Dr. Suh and colleagues evaluated certain factors influencing long-term survival
of brain metastases patients, including Karnofsky Performance Status (KPS),
site of primary, age, presence of extra cranial metastases, control of primary,
gender, presence of liver metastases, timing of brain metastases diagnosis,
prior brain tumor resection and number of brain metastases. Results of the
analysis indicated that KPS, prior brain tumor resection, the presence of extra
cranial metastases and gender were the strongest variables in predicting
outcome. Moreover, the analysis affirmed the effectiveness of the study drug,
EFAPROXYN, in improving survival time across a heterogeneous patient
population.
"This study has significant implications for the design of future randomized
trials in brain metastases patients," said Dr. Suh. "Our findings confirm the
impact of certain variables in determining survival outcome for brain
metastases patients. Moreover, the results demonstrated an improvement in
survival for patients with brain metastases who received EFAPROXYN and whole
brain radiation therapy (WBRT) with supplemental oxygen over those who received
WBRT with supplemental oxygen only."
Results from Dr. Suh'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 whole brain
radiation therapy (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 certain identified prognostic factors into the
stratification and design, including KPS and presence of liver metastases.
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. The primary endpoint of the trial was survival.
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/