SONUS COMPLETES SPA PROCESS WITH FDA FOR TOCOSOL PACLITAXEL

Sonus has announced that the FDA has completed a Special Protocol Assessment (SPA) for the pivotal Phase III trial of the company's lead cancer product candidate, Tocosol Paclitaxel.

Final written communication from the FDA, dated June 30 and received by the company on July 5, indicates that the FDA and Sonus have reached agreement on the protocol for the planned Phase III study of Tocosol Paclitaxel and on the formal written plans for how the study will be conducted. The Phase III study will compare Tocosol Paclitaxel and Taxol in the treatment of patients with breast cancer.

In the Phase III trial, approximately 800 patients will be randomly assigned to treatment with either Tocosol Paclitaxel or Taxol, and the effects of each drug on antitumor efficacy, tolerability and safety will be assessed. The study progress and interim data evaluations will be overseen by an independent data monitoring committee comprised of medical oncology and biostatistics experts not associated with the company.