Allos Therapeutics, Inc. (MM) (NASDAQ:ALTH)
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Analysis From Phase 3 Trial Suggests That Some Non-Small Cell
Lung Cancer Patients With Brain Metastases May Benefit From Allos Therapeutics'
RSR13 (Efaproxiral)
NEW ORLEANS, June 6 /PRNewswire-FirstCall/ -- Allos Therapeutics Inc.
(NASDAQ:ALTH) announced that a retrospective analysis of the results from its
Phase 3 trial of the investigational radiation sensitizer RSR13 (efaproxiral)
in patients with brain metastases demonstrated a survival benefit in a group of
patients with brain metastases originating from non-small cell lung cancer
(NSCLC). Preliminary data from the Phase 3 study RT-009 called REACH, were
first announced in April 2003. Abstract #7115, titled "Standard Whole Brain
Radiation Therapy (WBRT) with supplemental oxygen (O2) with or without RSR13
(efaproxiral) in patients with brain metastases originating from NSCLC: Results
of a subgroup analysis," was presented in a poster session on Saturday morning
by Abdenour Nabid, MD, from the Centre Hospitalier Universitaire de Sherbrooke
in Canada at the 40th Annual Meeting of the American Society of Clinical
Oncology. Dr. Nabid also served as an investigator for the study.
The REACH trial compared the median survival time (MST) of patients with brain
metastases originating from select solid tumors receiving RSR13 (efaproxiral)
and standard whole brain radiation therapy (WBRT) plus supplemental oxygen
compared with a control group of patients receiving WBRT and supplemental
oxygen alone. According to the abstract, Dr. Nabid's retrospective analysis
indicated that patients who were diagnosed with brain metastases more than one
month after they were diagnosed with NSCLC experienced a 31 percent reduction
in the risk of death when treated with RSR13 (efaproxiral) compared with
control. The analysis was conducted on the 299 NSCLC patients who enrolled in
the REACH study and evaluated MST as a function of the time period between
primary diagnosis of NSCLC and diagnosis of brain metastases. Patients in the
RSR13 (efaproxiral) arm (n=75) who were diagnosed with primary NSCLC and brain
metastases at least one month apart had a MST of 5.39 months compared with 4.37
months for controls (n=87), a 31 percent reduction in the risk of death for
patients receiving RSR13 (efaproxiral) [HR=0.77, 95% CI (0.55, 1.09)]. MST for
patients who had these diagnoses made within one month did not differ between
the 2 treatment arms (RSR13 [efaproxiral] [n=73] 4.5 months; Control [n=64] 4.8
months). The abstract may be accessed online at http://www.asco.org/ at the
conclusion of the meeting.
"These results are very encouraging," Dr. Nabid observed. "Previous studies
have reported that patients with brain metastases originating from NSCLC have
different prognosis depending on the time between diagnosis of their primary
tumors and diagnosis of their brain metastases. The results of this
retrospective analysis suggest that RSR13 (efaproxiral) may provide clinical
benefit to patients who have their primary and metastatic diagnoses made at
least one month apart. These data support the further evaluation of RSR13
(efaproxiral) and WBRT in this patient population."
"Data from ongoing analyses of the results of the REACH trial continue to
support the potential clinical utility of RSR13 (efaproxiral) and WBRT in the
treatment of brain metastases originating from solid tumors," said Michael E.
Hart, President and CEO of Allos Therapeutics, Inc.
The REACH study was a randomized, open label Phase 3 clinical trial designed to
demonstrate that RSR13 is safe and effective for treating patients with brain
metastases resulting from a variety of solid tumors. The study enrolled 538
patients and compared the safety and efficacy of RSR13 plus WBRT and
supplemental oxygen (271 patients) versus VBRT and supplemental oxygen (267
patients) in patients with brain metastases. The primary endpoint of the trial
was survival.
About RSR13 (efaproxiral)
RSR13 (efaproxiral) is the first synthetic small molecule designed to
"sensitize" hypoxic (oxygen-deprived) areas of tumors prior to 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, RSR13 (efaproxiral) has
the potential to enhance the efficacy of standard radiation therapy. Unlike
chemotherapeutics or other radiation sensitizers, RSR13 (efaproxiral) 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, RSR13 (efaproxiral), 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, an injectable small molecule chemotherapeutic agent
that has enhanced potency and better toxicity profile relative to methotrexate
and other dihydrofolate reductase, or DHFR, inhibitors. For more information,
please visit the company's web site at: http://www.allos.com/.
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 RSR13 for the treatment of brain metastases from NSCLC
or any other type of cancer, as well as other risks and uncertainties detailed
from time to time in the company's SEC filings, including its Annual Report on
Form 10-K for the year ended December 31, 2003, as amended. Results from
earlier clinical trials are not necessarily predictive of future clinical
results. 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: Fern Lazar of Lazar Partners Limited, +1-212-867-1762,
Web site: http://www.asco.org/
http://www.allos.com/