Allos Therapeutics, Inc. (MM) (NASDAQ:ALTH)
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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/