The phase III study is designed to evaluate the safety and efficacy of whole brain radiation therapy with increased oxygen. Efaproxyn increases the amount of oxygen in tumors – an essential element for the effectiveness of the radiation. The company hopes the drug will improve the success of standard radiation therapy.
A total of 360 patients were enrolled at 126 participating centers in the US, Canada, Europe and South America. The trial is being conducted under a special protocol assessment and is an agreement between the company and the FDA that the study adequately address the objectives of the study in support of an NDA submission.
Allos Therapeutics is now closer to introducing a drug that is suggested to have the potential to improve the survival and quality of life of this patient population.