The drug, ARRY-380, is a selective, orally-active ErbB-2 inhibitor which has shown good efficacy in preclinical models of human breast cancer resulting in significant anti-tumor activity, according to Array.
Array plans to commence the Phase I trial this autumn in the US and Canada. The open-label, multiple dose study is designed to evaluate safety, tolerability and pharmacokinetics of ARRY-380 following daily oral administration to patients with advanced cancer.
Herceptin, the intravenously-dosed protein therapeutic currently on the market, modulates ErbB-2 and generated over $3 billion in revenue in 2006. Array believes the advantages of its drug include patient preference for an orally-active drug as well as improved efficacy versus or in combination with standard of care in preclinical models of human breast cancer.