August 26, 2008

Aveo Initiates Phase Ib Colorectal Cancer Study

Aveo Pharmaceuticals has started another Phase Ib clinical study for its lead product candidate, the triple VEGF receptor inhibitor AV-951.

This open-label, sequential dose escalation study will be conducted at cancer institutions in Europe and will evaluate AV-951 in combination with the Folfox6 chemotherapy regimen in patients with advanced colorectal cancer and other gastrointestinal cancers.

This Phase Ib combination therapy trial is designed to determine the safety, tolerability and maximum tolerated dose of AV-951 when given in combination with Folfox6 in approximately 30 patients with advanced colorectal cancer and other gastrointestinal cancers.

Patients will receive once daily doses of AV-951 for three weeks followed by a one-week break, and Folfox6 (5FU, leucovorin and oxaliplatin) chemotherapy at standard doses once every two weeks. One cycle will be defined as four weeks of therapy, and patients will undergo tumor assessments after every two cycles. In the absence of disease progression or a serious adverse event, patients may continue to receive therapy with this regimen.

This study also includes an expansion cohort of an additional 12 patients with previously untreated metastatic colorectal cancer to evaluate preliminary clinical activity of this regimen in first-line treatment of colorectal cancer.

Tuan Ha-Ngoc, president and CEO of Aveo, said: "Due to the compelling activity and safety we have observed in our early data, we believe AV-951 offers a unique profile that will allow it to be used in combination with the current front-line regimens for cancer treatment, potentially benefiting the thousands of patients worldwide battling advanced colorectal cancer."