Application filed for European marketing approval of RSR13 (efaproxiral).

2004 JUL 1 - (NewsRx.com & NewsRx.net) -- Allos Therapeutics, Inc., (ALTH) announced 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 CEO 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.

Allos also announced that it has received an "approvable" letter from the FDA for its NDA for RSR13 (efaproxiral).

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. In the letter, the FDA stated, "if the study shows effectiveness in this population (increased survival) ...