Allos Therapeutics, Inc. (MM) (NASDAQ:ALTH)
Historical Stock Chart
From Jul 2019 to Jul 2024
![Click Here for more Allos Therapeutics, Inc. (MM) Charts. Click Here for more Allos Therapeutics, Inc. (MM) Charts.](/p.php?pid=staticchart&s=N%5EALTH&p=8&t=15)
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/