Allos Therapeutics, Inc. (MM) (NASDAQ:ALTH)
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Allos Therapeutics Announces RSR13 Phase 3 Results in Patients With Breast
Cancer and Brain Metastases Will Be Highlighted at the 26th Annual San Antonio
Breast Cancer Symposium
WESTMINSTER, Colo., Nov. 24 /PRNewswire-FirstCall/ -- Allos Therapeutics, Inc.
today announced that the data from its pivotal Phase 3 trial that evaluated the
investigational radiation sensitizer RSR13 (efaproxiral) in patients with brain
metastases will be presented at the 26th Annual San Antonio Breast Cancer
Symposium. The poster presentation will focus specifically on the patients in
the study that suffered from brain metastases and breast cancer.
Wednesday, December 3rd, 4:30-7:00 pm
Poster Session 1
Treatment: Radiation Therapy
#175 -- Results from a subgroup analysis of patients with metastatic
breast cancer (MBC) in a phase 3, randomized, open-label, comparative
study of standard whole brain radiation therapy (WBRT) with supplemental
oxygen, with or without RSR13, in patients with brain metastases.
(Presenter: D. Stea Baldessare, M.D.)
Based on the findings from the Phase 3 trial, 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.
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 (direct),
; or media, Fern Lazar of Lazar Partners Limited,
+1-212-867-1765, for Allos Therapeutics, Inc.
Web site: http://www.allos.com/