ImClone Expands IMC-A12 Development

ImClone Systems’ anti-insulin-like growth factor-1 receptor (IGR-IR) monoclonal antibody (known as IMC-A12) has received 10 proposals for Phase I/II trials from the Cancer Therapy Evaluation Program (CTEP) of the Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI).

The proposed trials follow NCI’s request for specific disease-directed studies among NCI investigators at academic institutions, clinical trial consortia and NCI-sponsored oncology cooperative clinical trial groups in the U.S. The 10 trials are the first stage of clinical evaluations of IMC-A12 sponsored by CTEP, NCI under a Clinical Trials Agreement between ImClone and DCTD, to facilitate the development of the drug.

The Phase II trials sponsored by CTEP will explore the clinical activity, pharmacology and biological effects of IMC-A12 as a single agent or combined with other relevant anticancer agents in a wide range of malignancies including breast, lung, pancreas and liver cancers, as well as both adult and pediatric sarcomas. Phase I/II studies will evaluate the safety, pharmacology, anticancer activity and biological effects of IMC-A12 in children and adolescents with cancer, as well as in combination with other targeting agents.

ImClone’s IMC-A12 is designed to target the human insulin-like growth factor type 1 receptor and inhibit certain ligands known as insulin-like growth factors I and II from binding to and activating the receptor. This action blocks the pathway that enables tumor cell growth.