Women's Health Weekly
Welcome to NewsRx!
Learn more about a six-week, no-risk free trial of Women's Health Weekly
We're a pay-per-view site for premium content. If you'd like to purchase this article, it's only $3.00.
Clinical Trials
SPA process completed for paclitaxel formulation clinical trial in breast cancer
August 11th, 2005
Sonus Pharmaceuticals, Inc. (SNUS) announced that the U.S. Food and Drug Administration (FDA) has completed a Special Protocol Assessment (SPA) for the pivotal phase 3 trial of the company's lead cancer product candidate, Tocosol Paclitaxel. Final written communication from the FDA indicates that the FDA and Sonus have reached agreement on the protocol for the planned phase 3 study of Tocosol Paclitaxel and on the formal written plans for how the study will be conducted. The phase 3 study will compare Tocosol Paclitaxel and Taxol in the treatment of patients with breast cancer. In the phase 3 trial, approximately 800 patients will be randomly...
Source: Women's Health Weekly (2005-08-11)
|
