Allos Therapeutics Announces RSR13 Phase 3 Results in Patients With Breast Cancer and Brain Metastases Will Be Highlighted at th
24 Novembre 2003 - 1:00PM
PR Newswire (US)
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/
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