ALLOS WITHDRAWS DRUG APPLICATION FOR REVAPROXYN

Allos Therapeutics has withdrawn its European marketing authorization application (MAA) for its investigational radiation sensitiser Revaproxyn (efaproxiral, Efaproxyn in the U.S.) for use as an adjunct to whole-brain radiation therapy for the treatment of patients with brain metastases originating from breast cancer.

The company concluded that the current data package was not sufficient to support approval. The MAA was based upon the results of the company's Phase III reach trial, which demonstrated a statistically significant survival benefit in patients with brain metastases originating from breast cancer, a subgroup of patients that was not prospectively defined as an intent-to-treat subgroup.

Efaproxyn is the first synthetic small molecule designed to sensitise hypoxic, or oxygen-deprived, areas of tumors during radiation therapy by facilitating the release of oxygen from haemoglobin, the oxygen-carrying protein contained within red blood cells, and increasing the level of oxygen in tumors.