Prognostic Factors Influencing Survival in Patients with Brain Metastases Identified in Largest Ever Randomized Study
04 Octobre 2004 - 9:30PM
PR Newswire (US)
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/
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