ImClone Systems Incorporated has announced that the first of its phase II clinical trials of the anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody IMC-A12 has commenced patient enrolment.
A randomised phase II study of IMC-A12 as a single agent or in combination with cetuximab, in patients with metastatic colorectal cancer with disease progression demonstrated during prior treatment with cetuximab, has begun to enrol patients. A total of 40 to 72 patients are expected to be enrolled. Based on supportive preclinical data indicating highly favourable anticancer interactions when IMC-A12 and cetuximab are combined, this phase II study is designed to evaluate the efficacy, safety and pharmacology of IMC-A12 administered every two weeks by intravenous infusion as a single agent and in combination with cetuximab.
"This first disease-directed study of IMC-A12 in combination with cetuximab paves the way for a wide range of activity finding studies, many of which will begin over the next several months in various rational tumour types," said Eric K. Rowinsky, MD, chief medical officer and senior vice president of ImClone Systems.
IMC-A12 is a fully human IgG1Mab that is designed to specifically target the human insulin-like growth factor type 1 receptor, thereby inhibiting certain ligands known as insulin-like growth factors I and II from binding to and activating the receptor. This action blocks a signaling pathway that enhances tumour cell proliferation and survival.
ImClone Systems Incorporated is committed to advancing oncology care by developing 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' strategy is to become a fully integrated biopharmaceutical company, taking its development programs from the research stage to the market. ImClone Systems' headquarters and research operations are located in New York City, with additional administration and manufacturing facilities in Branchburg, New Jersey.