RSR13Treatment for Brain Metastases in patients with Breast Cancer
Allos Therapeutics Announces New Trade Names for Efaproxiral in the U.S. and Europe
WESTMINSTER, Colo., June 16, 2004 -- 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 in the United States and Revaproxyn 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 (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 (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 www.allos.com
Posted: June 2004
- Allos Therapeutics Receives FDA Approvable Letter for RSR13 (efaproxiral) - June 2, 2004
- FDA Advisory Committee Does Not Recommend Approval of RSR13 as Adjunctive Therapy for the Treatment of Brain Metastases Originating From Breast Cancer - May 4, 2004
- Allos NDA To Be Reviewed By FDA Advisory Committee - March 12, 2004
- FDA Accepts Allos New Drug Application with Priority Review for RSR13 in Brain Metastases from Breast Cancer - February 3, 2004