Allos Therapeutics Announces New Trade Names for Efaproxiral in the U.S. and Europe
16 Juin 2004 - 3:01PM
PR Newswire (US)
Allos Therapeutics Announces New Trade Names for Efaproxiral in the
U.S. and Europe WESTMINSTER, Colo., June 16 /PRNewswire-FirstCall/
-- Allos Therapeutics, Inc. (NASDAQ:ALTH) announced today new
global trade names for its lead therapeutic, efaproxiral.
Efaproxiral, formerly known as RSR13, if approved by regulatory
authorities, will be marketed under the trade name EFAPROXYN(TM) in
the United States and REVAPROXYN(TM) outside the United States.
Allos filed applications in 2003 for the registration of both trade
names in the U.S., Europe and numerous other global markets.
Additionally, EFAPROXYN and REVAPROXYN have received clearance for
usage from the DMETS branch of the FDA and the Name Review Group of
the CHMP, respectively. On June 2nd, Allos announced that it
received an approvable letter from the U.S. Food and Drug
Administration (FDA) for its New Drug Application (NDA) for
EFAPROXYN(TM) (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. On June
4th, Allos announced the filing of a centralized Marketing
Authorization Application (MAA) with the European Medicines Agency
(EMEA) to market REVAPROXYN(TM) (efaproxiral) as an adjunct to
whole brain radiation therapy for the treatment of patients with
brain metastases originating from breast cancer. 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, 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 (pralatrexate), 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 obtain regulatory
approval to market EFAPROXYN in the United States or REVAPROXYN
outside the United States, 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. 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, +1-212-867-1762, for Allos Therapeutics,
Inc. Web site: http://www.allos.com/
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