Allos Completes New Drug Application for Novel Treatment for Patients With Breast Cancer and Brain Metastases

Allos Completes New Drug Application for Novel Treatment for Patients With
Breast Cancer and Brain Metastases 


WESTMINSTER, Colo., Dec. 4  /PRNewswire-FirstCall/ -- Allos Therapeutics, Inc. 
today announced it has submitted to the U.S. Food and Drug Administration (FDA)
the last component of its New Drug Application (NDA) for approval to market
RSR13 (efaproxiral) as an adjunct to whole brain radiation therapy for the
treatment of brain metastases from breast cancer.  The company submitted the
first component of its NDA for RSR13 in August 2003 under the FDA's rolling
submission process and has now completed this process with the submission of
clinical efficacy and safety data.  With the entire NDA submission now
completed, the FDA has 60 days to notify the company of whether or not it will
accept the NDA for filing and respond to the company's request for priority
review of the application.

The electronic submission was produced in an internationally agreed upon format
(eCTD) that facilitates regulatory review in the United States, Europe and
Japan.  The company plans to submit a Marketing Authorization Application (MAA)
in Europe for this indication in the first quarter of 2004.

RSR13 is the first of a new class of pharmaceutical agents being developed as a
radiation sensitizer to be used as an adjunct to radiation therapy.  A synthetic
small molecule, RSR13 decreases the hemoglobin-oxygen binding affinity, which
facilitates the release of oxygen from hemoglobin.  The presence of oxygen in
tumors is an essential element for the effectiveness of radiation therapy in the
treatment of cancer.  By increasing the oxygenation of tumor tissues at the time
of treatment, RSR13 has the potential to sensitize hypoxic (oxygen deprived)
tissues and enhance the efficacy of standard radiation therapy.  Unlike
chemotherapeutics or other radiosensitizers, RSR13 does not have to cross the
blood brain barrier or enter the tumor to be effective.

The final component of the NDA contains safety and efficacy data from over 700
patients treated with RSR13 under 17 study protocols and is based largely on the
company's recently completed pivotal Phase 3 clinical trial, one of the largest
randomized studies ever conducted in patients with brain metastases. Detailed
results of this Phase 3 trial were presented at The Society for Neuro-Oncology
Annual Meeting in November 2003.  The submission also includes supporting data
from three Phase 2 studies of RSR13 in patients with brain metastases, primary
non-small cell lung cancer and glioblastoma multiforme.

"This submission represents a significant milestone for patients, employees and
shareholders," said Michael E. Hart, President and CEO of Allos Therapeutics,
Inc.  "If approved, RSR13 will provide women battling brain metastases from
breast cancer with the first therapeutic specifically designed to improve the
efficacy of standard whole brain radiation therapy."

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 brain
cancer, 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 in the U.S.  Standard whole-brain radiation is
the primary palliative therapy for treating patients with brain metastases and
has been shown to prevent or reduce complications and to increase survival.

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, 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 whether or not the FDA will accept the company's NDA
for submission for filing, the company's ability to complete the submission of
its MAA to European authorities on schedule and in accordance with regulatory
requirements, and the company's ability to obtain regulatory approval for RSR13
in the U.S., Europe or any other jurisdiction, 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., [phone], or cell,

[phone],  ; or media, Fern Lazar of Lazar Partners

Limited, cell, [phone],  , for Allos

Therapeutics, Inc.



Web site:  http://www.allos.com/ 

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