October 1, 2008
ImClone Commences Enrollment for Phase II Ovarian Cancer Trial
ImClone Systems has announced that the first patient has been treated in its disease-directed Phase II clinical trial of IMC-1121B in patients with advanced ovarian cancer.
This multicenter, open-label Phase II single-arm study is enrolling women with persistent or recurrent advanced ovarian, fallopian tube, and primary peritoneal epithelial cancers following at least one platinum-containing chemotherapy regimen.
Approximately 55 patients are expected to be enrolled at various centers throughout the US and Europe. This Phase II study is designed to evaluate the efficacy and safety of IMC-1121B administered as an intravenous infusion every two weeks in this disease setting.
IMC-1121B is ImClone's proprietary fully human, IgG1 anti-vascular growth factor receptor-2 monoclonal antibody.
Eric Rowinsky, chief medical officer and executive vice president of ImClone, said: "We are very excited about this proof-of-concept trial, which can serve as a building block for the development of combination studies with IMC-1121B and registration-directed activity in various ovarian cancer settings."