Phase 2 Study of IMC-1121B for Advanced Ovarian Cancer Commences Patient Enrollment
NEW YORK--(BUSINESS WIRE)--ImClone Systems Incorporated (NASDAQ: IMCL), a global leader in the development and commercialization of novel antibodies to treat cancer, today announced that the first patient has been treated in its disease-directed Phase 2 clinical trial of IMC-1121B in patients with advanced ovarian cancer. IMC-1121B is ImClone's proprietary fully human, IgG1 anti-vascular growth factor receptor-2 (VEGFR-2) monoclonal antibody.
This multicenter, open-label Phase 2 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 U.S. and Europe. This Phase 2 study is designed to evaluate the efficacy and safety of IMC-1121B administered as an intravenous infusion every two weeks in this disease setting.
"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," said Eric K. Rowinsky, M.D., Chief Medical Officer and Executive Vice President of ImClone. "The growth of ovarian cancer appears to be dependent on VEGFR-2 stimulation and early signs of clinical activity have been observed in patients treated with various agents targeting the VEGFR-2 axis. We believe that IMC-1121B may confer a more favorable therapeutic index, meaning a greater potential for activity and a lower potential for side effects, than other antiangiogenic agents in this and other cancer settings because it is highly specific for the VEGFR-2 and blocks many VEGF ligands from binding to the receptor."
IMC-1121B is a fully human IgG1 monoclonal antibody designed to bind to the extracellular domain of VEGFR-2 found on tumor vasculature, thereby inhibiting certain ligands known as vascular endothelial growth factors from binding to and activating the receptor. This action blocks a signaling pathway key to new blood vessel formation in growing tumors, which has been shown to starve tumors of their nutrient supply and result in significant tumor growth inhibition in pre-clinical models. In addition to this Phase 2 study announced today, disease-directed studies of IMC-1121B in patients with advanced melanoma, liver, renal, and prostate cancers have begun to enroll patients, and additional Phase 2 and 3 evaluations are in various stages of development. In April 2008, ImClone announced an agreement with the Food and Drug Administration on a Special Protocol Assessment for a Phase 3 study of IMC-1121B in women with metastatic breast cancer, which has begun to enroll patients.
About ImClone Systems
ImClone Systems Incorporated is a fully integrated global biopharmaceutical company committed to advancing oncology care by developing and commercializing a portfolio of targeted biologic treatments designed to address the medical needs of patients with a variety of cancers. The Company's research and development programs include growth factor blockers and angiogenesis inhibitors. ImClone Systems' headquarters and research operations are located in New York City, with additional administration and manufacturing facilities in Branchburg, New Jersey. For more information about ImClone Systems, please visit the Company's web site at http://www.imclone.com.
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