First component of rolling NDA submitted for RSR13.

2003 SEP 4 - (NewsRx.com & NewsRx.net) -- Allos Therapeutics, Inc., (ALTH) announced that it has begun submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for the company's investigational radiation sensitizer, RSR13 (efaproxiral), for the treatment of patients with breast cancer that has metastasized to the brain.

The electronic submission was produced in the Common Technical Document format, which is an internationally agreed upon format that facilitates regulatory review in the USA, Europe, and Japan. The submission will occur on a "rolling" basis and is expected be completed by the end of the year. The first component submitted contained the nonclinical section, consisting of one CD-ROM containing 40 volumes and more than 6,900 pages of data and analysis. The chemistry, manufacturing, and controls (CMC) and the clinical modules will be submitted later this year.

When complete, the NDA submission will contain safety and efficacy data from over 700 patients treated under 17 RSR13 study protocols and will be based largely on the company's recently completed pivotal phase III clinical trial, one of the largest randomized studies ever conducted in patients with brain metastases. The submission will also include supporting data from three phase II studies of RSR13 in patients with brain metastases, primary non-small cell lung cancer and glioblastoma multiforme.

"The submission of the first section of our NDA to the FDA is an extremely ...