Arizona Cancer Center Investigator Presents Positive Survival and Quality of Life Data From RSR13 Phase 3 Study

Arizona Cancer Center Investigator Presents Positive Survival and Quality of
Life Data From RSR13 Phase 3 Study 


SAN ANTONIO, Texas, Dec. 3  /PRNewswire-FirstCall/ -- Allos Therapeutics, Inc. 
announced the presentation of positive findings from its Phase 3 clinical trial
of the investigational radiation sensitizer RSR13 (efaproxiral).  The results
demonstrate a significant survival benefit for women with breast cancer and
brain metastases who received RSR13 plus whole brain radiation therapy (WBRT)
versus WBRT alone.  Baldassarre Stea, M.D., Ph.D., Head of the Department of
Radiation Oncology at the Arizona Health Sciences Center in Tucson, presented
the findings today at the 26th Annual San Antonio Breast Cancer Symposium.

In poster number 175, entitled "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,"
Dr. Stea and colleagues showed that adding RSR13 to WBRT with supplemental
oxygen nearly doubled the median survival rate of patients with breast cancer
and brain metastases to 8.67 months versus 4.57 months for patients who received
WBRT alone (p=0.006).  Patients with breast cancer and brain metastases who were
treated with RSR13 plus WBRT also achieved a higher response rate in the brain
than the control group (71.7% vs. 49.1%; p=0.02). A statistically significant
stable or improvement in quality of life at 3 months was observed in patients
receiving RSR13, as assessed by the Karnofsky Performance Score(1) (35% vs. 18%;
p=0.001) and the Spitzer Index(2)(37% vs. 24%; p=0.01).  In general, patients
experienced minimal serious adverse events with the most common being hypoxemia
(3.4% n=266), which is dose-dependent and effectively managed with supplemental
oxygen.

"The presentation of survival and quality of life data at this meeting validates
the potential of RSR13 to increase the effectiveness of radiation therapy in
breast cancer patients with brain metastases," said Michael E. Hart, President
and CEO of Allos Therapeutics, Inc.  "Brain metastases are devastating to
patients and new therapies are desperately needed."

"You would expect patients with higher response rates in the brain to live
longer and that's exactly what we saw in breast cancer patients," said Dr. Stea.
 "Additional analyses of the data set continue to deliver encouraging news
regarding the potential benefits of using RSR13 with whole brain radiation
therapy in patients with metastatic breast cancer.  These data suggest that
RSR13 has a positive treatment effect on survival and quality of life in
patients struggling with breast cancer and brain metastases, providing added
hope in their fight against cancer."

The preliminary results from the 538-patient randomized Phase 3 trial of RSR13
were announced in April 2003.  The results did not meet the primary survival
endpoint of the study using standard log rank analysis.  In the overall study
population, patients receiving RSR13/WBRT experienced a 17.6% improvement in
median survival compared to patients receiving WBRT alone (5.26 months vs. 4.47
months; p=0.17; n=538).  However, the survival benefit for RSR13 was
statistically significant in a pre-specified Cox multiple regression model
(Hazard Ratio 0.775 [95% CI 0.639, 0.941], p=0.010).  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 granted Fast Track Product
designation for RSR13 in November 2000.  The company expects to complete its
rolling NDA submission this month.

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 (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 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.

   (1) The Karnofsky Performance Status Scale (KPS) was designed to measure
       the level of patient activity and medical care requirements.  It is a
       general measure of patient independence and has been widely used as a
       general assessment of a patient with cancer.
   (2) The Spitzer Index is a global measure that captures the three
       components of health (social, physical and psychological).  It is a
       self-report measure that allows comparison across a variety of cancer
       trials.


DATASOURCE: Allos Therapeutics, Inc.



CONTACT:  Monique M. Greer, VP, Corporate Communications and IR 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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