Morphotek announced that the FDA has agreed to and approved the design of a single, pivotal, Phase 3 clinical trial evaluating farletuzumab (MORAb-003) in platinum-sensitive ovarian cancer patients experiencing their first relapse. This agreement was made under the Special Protocol Assessment (SPA) procedure.
The Phase 3 study will assess the capacity of farletuzumab to extend progression free survival and overall survival in combination with carboplatin and taxane at two different dose levels of farletuzumab. It will be conducted as a randomized, double-blind, placebo-controlled trial enrolling 900 patients at sites in North America, South America, Europe, Australia and Asia.
Farletuzumab is a monoclonal antibody that binds to and blocks the function of folate receptor alpha (FRA), a cell surface protein on tumor cells that confers a growth advantage to tumorigenic cells in vitro.
For more information please call (610) 423-6100 or visit www.morphotek.com.