Allos Therapeutics Receives FDA Approvable Letter for RSR13 (efaproxiral)

Allos Therapeutics Receives FDA Approvable Letter for RSR13
(efaproxiral)
- Additional Clinical Data Requested to Support Approval - 


WESTMINSTER, Colo., June 2  /PRNewswire-FirstCall/ -- Allos Therapeutics, Inc.
(NASDAQ:ALTH) announced today that it has received an "approvable" letter from
the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA)
for RSR13 (efaproxiral) for the treatment of patients with brain metastases
originating from breast cancer.

In the letter, the FDA indicated that before the NDA may be approved, it will
be necessary for Allos to complete its ongoing Phase III clinical trial of
RSR13 in patients with brain metastases originating from breast cancer and
submit the results as an NDA amendment for the FDA's review.  The ongoing Phase
III trial, called ENRICH (ENhancing Whole Brain Radiation Therapy In Patients
with Breast Cancer and Hypoxic Brain Metastases), will seek to enroll
approximately 360 patients at up to 50 cancer centers across North America. In
the letter, the FDA stated, "if the study shows effectiveness in this
population (increased survival) using the pre-specified analysis, and the study
is otherwise satisfactory, we believe it would, together with the subset result
in RT-009, support approval".

No other specific deficiencies were noted in the approvable letter. However,
the FDA indicated that additional general comments from Clinical Pharmacology,
Pharmacology/Toxicology and Chemistry would be forwarded separately.  The FDA
also noted that it has not completed its inspection of the manufacturing and
controls facilities listed in the NDA, which remains a prerequisite to approval
of the NDA.

"We are pleased that the FDA has determined that RSR13 is approvable, assuming
a favorable outcome of our ENRICH study," said Michael Hart, President and
Chief Executive Officer of Allos.  "We remain focused on completing the
enrollment of the ENRICH study as soon as possible, and will continue to work
with the FDA with the goal of advancing RSR13 toward approval."

About RSR13 (efaproxiral)

RSR13 (efaproxiral) is the first synthetic small molecule designed to sensitize
hypoxic, or oxygen-deprived, areas of tumors prior to radiation therapy by
facilitating the release of oxygen from hemoglobin, the oxygen-carrying protein
contained within red blood cells, and increasing the level of oxygen in tumors.
 The presence of oxygen in tumors is an essential element for the effectiveness
of radiation therapy in the treatment of cancer. By increasing tumor
oxygenation at the time of treatment, we believe RSR13 (efaproxiral) has the
potential to enhance the efficacy of standard radiation therapy.

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, an injectable small molecule
chemotherapeutic agent that has an enhanced potency and toxicity profile
relative to methotrexate and other dihydrofolate reductase, or DHFR,
inhibitors.  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 successfully complete the
ENRICH trial on schedule and in accordance with regulatory requirements, the
company's ability to adequately demonstrate the safety and efficacy of RSR13
for the treatment of brain metastases from breast cancer or any other type of
cancer, and the company's ability to raise additional capital to support its
operations, 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, 2003, as amended, and its Quarterly Report on Form 10-Q
for the quarter ended March 31, 2004.  Results from earlier clinical trials are
not necessarily predictive of future clinical results.  The company cautions
investors not to place undue reliance on the forward-looking statements
contained in this press release.  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:  Fern Lazar of Lazar Partners Ltd., [phone], for Allos

Therapeutics, Inc.



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

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