Allos Therapeutics Files Application for European Marketing Approval of RSR13 (efaproxiral)
June 04 2004 - 8:00AM
PR Newswire (US)
Allos Therapeutics Files Application for European Marketing
Approval of RSR13 (efaproxiral) WESTMINSTER, Colo., June 4
/PRNewswire-FirstCall/ -- Allos Therapeutics, Inc. (NASDAQ:ALTH)
announced today that it has filed a Marketing Authorization
Application (MAA) with the European Medicines Agency (EMEA) to
market RSR13 (efaproxiral) as an adjunct to whole brain radiation
therapy for the treatment of patients with brain metastases
originating from breast cancer. The MAA for RSR13 (efaproxiral) was
filed under the EMEA's centralized procedure and will be reviewed
by the EMEA's Committee for Medicinal Products for Human Use
(CHMP). The centralized procedure is used when marketing
authorization is applied for in all EMEA member states
simultaneously. In May 2004, the EMEA expanded to 25 member states
and the CHMP replaced the Committee for Proprietary Medicinal
Products. "Products for the treatment of patients with brain
metastases originating from breast cancer remains an unmet medical
need in Europe," said Michael E. Hart, President and Chief
Executive Officer of Allos. "The filing of the MAA is the first
step in the process for seeking approval to market RSR13 throughout
Europe for the treatment of these critically ill patients." The MAA
is based upon the results of the Company's REACH trial, which were
first announced in April 2003, and which formed the basis for the
Company's filing with the U.S. Food and Drug Administration (FDA)
of its New Drug Application (NDA) for RSR13 for the treatment of
patients with brain metastases originating from breast cancer. In
the REACH trial, patients with brain metastases originating from
breast cancer receiving RSR13 plus whole brain radiation therapy
(WBRT) achieved a median survival of 8.67 months versus 4.57 months
when receiving WBRT alone. Patients with brain metastases
originating from breast cancer represent a subset of patients that
was not prospectively defined as an intent-to-treat subgroup in the
REACH trial. In June 2004, the Company announced it had received an
"approvable" letter from the FDA with respect to the NDA. In the
letter, the FDA indicated that before the NDA may be approved, it
would be necessary for the Company to successfully complete its
Phase III clinical trial of RSR13 in patients with brain metastases
originating from breast cancer that has been ongoing since February
2004, and submit the results of the trial as an NDA amendment for
the FDA's review. 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 adequately demonstrate the
safety and efficacy of RSR13 for the treatment of brain metastases
from breast cancer or any other type of cancer, the EMEA's
willingness to approve a drug based upon an analysis of a subset of
patients that was not prospectively defined as an intent-to-treat
subgroup, and the company's ability to otherwise obtain regulatory
approval for RSR13 from the EMEA, the FDA or any other regulatory
agency, 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
Ltd., +1-212-867-1762, for Allos Therapeutics, Inc. Web site:
http://www.allos.com/
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