Allos NDA to be Reviewed by FDA Advisory Committee
13 March 2004 - 6:54AM
PR Newswire (US)
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/
Copyright
Allos Therapeutics, Inc. (MM) (NASDAQ:ALTH)
Historical Stock Chart
From Jun 2024 to Jul 2024
Allos Therapeutics, Inc. (MM) (NASDAQ:ALTH)
Historical Stock Chart
From Jul 2023 to Jul 2024
Real-Time news about Allos Therapeutics, Inc. (MM) (NASDAQ): 0 recent articles
More Allos Therapeutics (MM) News Articles