Allos Therapeutics, Inc. (MM) (NASDAQ:ALTH)
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Allos NDA to be Reviewed by FDA Advisory Committee
WESTMINSTER, Colo., March 12 /PRNewswire-FirstCall/ -- Allos Therapeutics, Inc.
announced today that the Oncologic Drugs Advisory Committee (ODAC) of the U.S.
Food and Drug Administration (FDA) plans to review the company's investigational
radiation sensitizer, RSR13 (efaproxiral), on May 3, 2004. Information
regarding the ODAC panel is now available via the FDA Hotline at 1-800-741-8138
and will soon be posted to the Federal Register.
On February 2, 2004, the FDA accepted for priority review the company's New Drug
Application (NDA 21-661) seeking approval to market RSR13 as an adjunct to whole
brain radiation therapy for the treatment of patients with brain metastases
originating from breastcancer. The FDA has established a target date of June
4, 2004 to take action on the NDA.
"We welcome the additional review and insight the FDA's outside scientific
advisors will provide at the ODAC hearing," said Michael E. Hart, President and
CEO ofAllos Therapeutics, Inc. "The recent acceptance for priority review of
our NDA exemplifies our ongoing cooperative efforts with the FDA."
About RSR13 (efaproxiral)
RSR13 (efaproxiral) is the first synthetic small molecule designed to
"sensitize" hypoxic (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, RSR13 (efaproxiral) has the
potential to enhance the efficacy of standard radiation therapy. Unlike
chemotherapeutics or other radiation sensitizers, RSR13 (efaproxiral) does not
have to cross the blood brain barrier or enter the tumor to be effective.
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 a superior 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 timing and scope of the ODAC review meeting, the
timing of the FDA's action on the NDA, and the company's ability to obtain
regulatoryapproval for RSR13 (efaproxiral) for the treatment of brain
metastases from breast cancer in the United States, 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, 2003. 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, ; or
media, Fern Lazar of Lazar Partners Limited, +1-212-867-1762,
, for Allos Therapeutics, Inc.
Web site: http://www.allos.com/