Allos up on RSR13 NDA plans

ALTH was up $1.42 (61%) to $3.73 on 6.7 million shares on Thursday on news that it plans to begin submitting a rolling NDA for its RSR13 efaproxiral radiation sensitizer for brain metastases from breast cancer in third quarter. ALTH said the decision comes after meetings with the FDA, and plans to complete the submission by year end. In a Phase III trial, RSR13 plus whole brain radiation therapy (WBRT) failed to significantly increase overall survival in metastatic brain cancer patients (see BioCentury, April 28, 2003). However, the compound did improve survival in a subset of 115 patients with metastatic breast cancer compared to WBRT alone (p=0.006). ...