Data From Phase 3 Trial of Allos Therapeutics' RSR13 (efaproxiral) Presented at ASCO
June 06 2004 - 1:05PM
PR Newswire (US)
Data From Phase 3 Trial of Allos Therapeutics' RSR13 (efaproxiral)
Presented at ASCO NEW ORLEANS, June 6 /PRNewswire-FirstCall/ --
Allos Therapeutics, Inc. (ALTH) announced that results from its
Phase 3 clinical trial of the investigational radiation sensitizer
RSR13 (efaproxiral) in patients with brain metastases were
presented in a poster session on Saturday at the 40th Annual
Meeting of the American Society of Clinical Oncology. Preliminary
results from the Phase 3 study, called REACH, were first announced
in April 2003. John H. Suh, M.D., Clinical Director, Radiation
Oncology, Brain Tumor Institute at the Cleveland Clinic Foundation
and Principal Investigator on the study presented the data in
abstract #1534, titled "Standard Whole Brain Radiation Therapy
(WBRT) with supplemental oxygen (O2), with or without RSR13
(efaproxiral) in patients with brain metastases: Results of the
randomized REACH (RT-009) study." In the overall study population
of 538 patients with brain metastases originating from select solid
tumors, the RSR13 (efaproxiral) arm demonstrated a 17.6 percent
improvement in MST compared with the control group (5.26 mo vs.
4.47 mo; p=0.17). In a Cox multiple regression model patients in
the RSR13 (efaproxiral) arm had a 22 percent reduction in the risk
of death (Hazard Ratio 0.78 [95% CI 0.64, 0.94], p=0.010) compared
to control. A pre-specified subset of patients with brain
metastases originating from breast cancer or non-small cell lung
cancer (NSCLC) (n=414) receiving RSR13 (efaproxiral) demonstrated a
32.4 percent increase in MST compared with the control group (5.91
mo vs. 4.47 mo; p=0.12). In patients with brain metastases
originating from breast cancer (n=115) the MST almost doubled in
those patients who received RSR13 (efaproxiral) and was
statistically significant compared with the control group (8.67 vs.
4.57 mo; p=0.006). Patients with brain metastases originating from
breast cancer represent a subset of patients that was not
prospectively defined as an intent-to-treat subgroup in the Phase 3
trial. The abstract may be accessed online at http://www.asco.org/
at the conclusion of the meeting. Dr. Suh commented, "These results
are very promising and the survival benefit and improved quality of
life observed in this trial in patients with brain metastases from
breast cancer are especially encouraging. This patient population
needs new therapeutic approaches that positively impact survival
and quality of life. These data support the continued evaluation of
RSR13 (efaproxiral) in patients with brain metastases originating
from breast cancer and, potentially, from other solid tumors as
well." Other key findings from the study include: -- The percentage
of breast cancer patients with stable or improved Karnofsky
Performance Status, a measure of quality of life, at 3 months was
significantly higher in the RSR13 (efaproxiral) arm compared with
controls (35 percent vs. 18 percent, p=0.001). -- Only 7 percent of
patients treated with RSR13 (efaproxiral) experienced a serious
adverse event (SAE) related to the drug. The most common SAE was
hypoxia (3.4 percent), which was dose-dependent and effectively
managed with supplemental oxygen. "We are currently conducting the
ENRICH (ENhancing Whole Brain Radiation Therapy In Patients with
Breast Cancer and Hypoxic Brain Metastases) trial, which is
designed to confirm the promising results observed in the REACH
trial in patients with brain metastases originating from breast
cancer," said Michael E. Hart, President and CEO of Allos
Therapeutics, Inc. "We recognize that this patient population has
significant unmet medical need and we believe that RSR13
(efaproxiral) may provide these patients with a new approach to
treating their disease." Allos recently launched a multi-center
Phase 3 randomized open label trial of RSR13 (efaproxiral) as an
adjunct to whole brain radiation therapy for the treatment of brain
metastases from breast cancer. The trial, called ENRICH (ENhancing
Whole Brain Radiation Therapy In Patients with Breast Cancer and
Hypoxic Brain Metastases), will seek to enroll approximately 360
patients at up to 50 cancer centers across North America. 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 an
enhanced potency and 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 successfully complete the
ENRICH trial on schedule and in accordance with regulatory
requirements, and the company's ability to adequately demonstrate
the safety and efficacy of RSR13 for the treatment of brain
metastases from breast cancer 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, , for Allos Therapeutics, Inc. Web site:
http://www.allos.com/ http://www.asco.org/
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