Allos Therapeutics Announces Presentation of RSR13 Phase 3 Results in Brain Metastases at the Eighth Annual Meeting of the Socie
November 17 2003 - 6:00AM
PR Newswire (US)
Allos Therapeutics Announces Presentation of RSR13 Phase 3 Results
in Brain Metastases at the Eighth Annual Meeting of the Society for
Neuro-Oncology WESTMINSTER, Colo., Nov. 17 /PRNewswire-FirstCall/
-- Allos Therapeutics, Inc. announced the presentation for the
first time of the results from the company's completed pivotal
Phase 3 trial of its investigational radiation sensitizer RSR13
(efaproxiral) for the treatment of patients with brain metastases.
The presentation took place on November 15, 2003 at the Eighth
Annual Meeting of The Society for Neuro-Oncology held in Keystone,
Colorado. The conference gathers thought leaders to review and
discuss the latest clinical data, new discoveries and emerging
treatment strategies in neuro-oncology. The presentation, entitled
"A Phase 3, Randomized, Open-Label, Comparative Study of Standard
Whole Brain Radiation Therapy (WBRT) with Supplemental Oxygen (O2),
With or Without RSR13, in Patients with Brain Metastases," was
given by study co-chair John H. Suh, M.D., Clinical Director,
Radiation Oncology, Brain Tumor Institute at the Cleveland Clinic.
Dr. Suh provided an overview of the survival data from the
randomized, open-label pivotal Phase 3 RSR13 trial. These data
showed that patients receiving RSR13 plus WBRT experienced a 17.6
percent improvement in median survival compared to patients
receiving WBRT alone (5.26 months vs. 4.47 months; p = 0.17; n =
538). The survival benefit for RSR13 was statistically significant
in a Cox multiple regression model (Hazard Ratio 0.775 [95% CI
0.639, 0.941], p = 0.010). The risk of death in all patients
treated was reduced by 22 percent when RSR13 was added to whole
brain radiation therapy in patients with brain metastases. Among
patients with breast cancer and brain metastases, RSR13's
therapeutic benefit was even more beneficial and showed a near
doubling of the median survival (4.57 vs. 8.67 months). Based on
the findings from this study, the company is currently submitting a
rolling New Drug Application (NDA) for RSR13 as an adjunct to WBRT
for the treatment of brain metastases originating from breast
cancer to the U.S. Food and Drug Administration (FDA). The FDA has
granted Fast Track Product designation for RSR13. The company
expects to complete its NDA submission in December 2003. Key
findings presented at the meeting include: -- RSR13 significantly
improved median survival in all randomized patients with brain
metastases, when adjusted for imbalances in all pre-specified
prognostic factors. -- Statistically significant stable or
improving Karnofsky Performance Status (KPS) over time was observed
in all randomized patients receiving RSR13. -- A statistically
significant increase in response rate in the brain in breast cancer
patients with brain metastases receiving RSR13 versus control
(49.1% vs. 71.7%, p = .01). Response was assessed by centralized
blinded review of MRI or CT scans. -- A clear dose/response
relationship was demonstrated for RSR13 in this study. Breast
cancer patients were optimally dosed compared to non- small cell
lung cancer patients resulting in a superior outcome for this
population. -- Patients with breast cancer in both the RSR13 and
control arms were well matched in terms of prior therapy and
subsequent therapy. -- RSR13 was safe and well tolerated by all
patients in the study. "We are pleased to have this forum in which
to present our Phase 3 trial results for the first time," said
Michael E. Hart, President and CEO of Allos Therapeutics, Inc. "The
results from our Phase 3 study suggest RSR13 has a clear treatment
effect in this patient population while maintaining or improving
quality of life. I am truly excited by the potential of this drug
to address a significant unmet medical need." About Brain
Metastases in Breast Cancer Patients Approximately 200,000 women
and 1,300 men will be diagnosed with breast cancer in the United
States in 2003. Approximately 20-to-30 percent of these breast
cancer patients will develop brain metastases. The most common type
of intracranial malignancy, brain metastases are tumors that have
spread to the brain from a malignant tumor in another part of the
body. This condition occurs in approximately one out of five cancer
patients, most often in patients with breast cancer or non-small
cell lung cancer. There are approximately 175,000 annual cases of
brain metastases. 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, a novel small molecule cytotoxic injectable
antifolate (DHFR inhibitor) being developed for 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/ . 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 complete the submission of its
NDA to the FDA on schedule and in accordance with regulatory
requirements, to adequately demonstrate the safety and efficacy of
RSR13 for use as a radiation sensitizer in the treatment of
metastatic breast cancer and any other type of cancer, and its
ability to obtain regulatory approval for RSR13, 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, 2002. 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: Monique
M. Greer, VP, Corporate Communications and Investor Relations of
Allos Therapeutics, Inc., +1-720-540-5241, ; or media, Fern Lazar
of Lazar Partners Limited, +1-212-867-1765, for Allos Therapeutics,
Inc. Web site: http://www.allos.com/
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