Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Array BioPharma has filed an investigational new drug application for its breast cancer drug with the FDA and is now able to proceed with a Phase I clinical trial.
Subscribe to our email newsletter
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.