Tuan Ha-Ngoc, the president and CEO of Aveo Pharmaceuticals ($AVEO), is leading a very smart charge to advance tivozanib to the market for kidney cancers called advanced renal cell carcinoma (RCC).
In June 2010, the company showed results from a Phase II study of a the drug--a potent blocker of all three vascular endothelial growth factor (VEGF) receptors, which play a role in the formation of blood vessels that feed tumors--that patients taking the drug on average lived without their cancer getting worse for 11.8 months. That same key indicator of effectiveness was nearly 14.8 months among patients with a clear cell form of RCC who had prior surgeries to remove at least part of their kidneys.
In the company's 517-patient Phase III trial comparing tivozanib head-to-head with Onyx Pharmaceuticals' and Bayer's Nexavar, patients who enter the study must have a clear cell form of the disease and previously have had the surgery to be eligible (the types of patients who did really well in the Phase II study). Aveo plans to report results of the trial in mid-2011. It's also worth keeping an eye on Pfizer's similar drug, axitinib, for which the drug giant plans to submit in 2011 applications for U.S. and European regulatory approvals as a treatment for patients with kidney cancer.
Aveo is sharing equally North American and European development costs and profits related to tivozanib with Japan's Astellas Pharma. Kyowa Hakko Kirin has rights to develop and commercialize the drug in Asia.