Updated Results of Allos' Phase 3 Reach Study Confirm Survival Benefit in Patients With Brain Metastases From Breast Cancer
31 Octobre 2004 - 3:00PM
PR Newswire (US)
Updated Results of Allos' Phase 3 Reach Study Confirm Survival
Benefit in Patients With Brain Metastases From Breast Cancer
VIENNA, Austria, Oct. 31 /PRNewswire-FirstCall/ -- Allos
Therapeutics, Inc. (NASDAQ:ALTH) announced today the presentation
of updated results 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. John H.
Suh, M.D., Director, Gamma Knife Center, 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 29th Annual Meeting of the
European Society for Medical Oncology. In abstract #785, titled
"Standard Whole Brain Radiation Therapy (WBRT) Plus Supplemental
Oxygen (O2) with or without Efaproxiral (EFAPROXYN) in Patients
with Brain Metastases: Updated Survival Results of the Randomized
REACH (RT-009) Study," Dr. Suh and colleagues presented an updated
survival analysis of enrolled patients from the time of
randomization until death or January 2004, whichever occurred
first. Results of the analysis indicated that the addition of
EFAPROXYN to whole brain radiation therapy (WBRT) led to a
significant reduction in the risk of death for the co-primary
patient populations (all eligible patients and all eligible lung
and breast patients), consistent with results reported previously.
Specifically, there was a 21% (95% CI: 5%-35%) and 23% (95% CI:5% -
38%) reduction in the risk of death, for all eligible patients and
all eligible lung and breast cancer patients respectively.
Moreover, Dr. Suh's analysis affirmed a distinct survival benefit
for patients with brain metastases originating from breast cancer
in the EFAPROXYN arm. Two-year survival for breast cancer patients
was 17% in the EFAPROXYN arm as compared to 0% in the control arm.
"Our findings confirm an improvement in survival after accounting
for baseline prognostic factors for patients with NSCLC and primary
breast cancer who received EFAPROXYN and WBRT with supplemental O2
over those who received WBRT with supplemental O2 only," said Dr.
Suh. "The additional one-year follow-up reinforces EFAPROXYN's
effectiveness in improving patient survival time, particularly in
patients with brain metastases originating from breast cancer." To
further confirm the survival benefit observed in the breast cancer
sub- group, in February 2004, Allos 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 whole brain radiation therapy (WBRT) with supplemental
oxygen with or without EFAPROXYN in women with brain metastases
from breast cancer. Allos is currently enrolling patients in the
ENRICH study at leading cancer centers across North America and
expects to expand enrollment to Europe and South America shortly.
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 non- 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.
About EFAPROXYN EFAPROXYN(TM) (efaproxiral) 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) that is currently
being investigated in patients with non-small cell lung cancer 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 type
of cancer, 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, Web site: http://www.allos.com/
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