Pharmaceutical Business review

OSI Pharmaceuticals Initiates Two Clinical Trials With OSI-906

OSI Pharmaceuticals has initiated two clinical trials with OSI-906, an oral insulin-like growth factor-1 receptor (IGF-1R) inhibitor.

The first study is a phase III, multi-center study that will evaluate the use of OSI-906 for patients with locally advanced or metastatic adrenocortical carcinoma (ACC). The study is designed to determine overall survival for patients receiving single-agent OSI-906 versus placebo and will also evaluate progression free-survival, disease control rate, overall response rate as well as safety.

The second study is a phase I/II trial evaluating OSI-906 in combination with the chemotherapy paclitaxel (Taxol), primarily in patients with recurrent epithelial ovarian cancer.

Colin Goddard, chief executive officer of OSI Pharmaceuticals, said: “Data from our phase I program for OSI-906 show encouraging evidence of anti-tumor activity, particularly in adrenocortical carcinoma. We are pleased to initiate a phase III trial in this underserved patient population where the only approved therapy is Mitotane, a cytotoxic derivative of the pesticide DDT.”

OSI-906 is a potent inhibitor of IGF-1R which has been viewed as an important therapeutic target due to its involvement in the growth and proliferation of a variety of human cancers, including ACC, ovarian and non-small cell lung (NSCLC) cancers.