Patients and doctors looking for a new option for the tough-to-treat kidney cancer are likely to get a potential but safe arsenal soon.

Tivozanib, an experimental pill from Aveo Pharmaceuticals, has been found to be highly effective and safe in treating kidney cancer, reports after early testing suggests.

The drug has been tested on 272 patients with advanced renal cell carcinoma (RCC) and it was found to extend the survival of kidney cancer patients compared to other drugs used to treat the disease. This efficacy profile may enable Tivozanib to be more readily combined with standard chemotherapy as well as other targeted therapies, thus potentially increasing the breadth of its clinical utility.

In February 2010, Aveo initiated patient enrollment in the TIVO-1 trial, a global Phase 3 clinical trial, for Tivozanib in advanced RCC. The trial will compare tivozanib with Sorafenib (Nexavar), a leading therapy for kidney cancer.

Sorafenib is approved by both the U.S. Food and Drug Administration and the European Medicines Agency (EMA) for use in patients with advanced RCC. Patients with RCC of clear cell histology that have had a prior nephrectomy and that have not received prior VEGF-targeted therapy are eligible for this trial.

Patients who demonstrate disease progression during treatment with Sorafenib will have the opportunity to be treated with tivozanib by participating in a separate long-term treatment.

In addition to the TIVO-1 trial, Aveo is currently conducting multiple Phase-1B clinical trials of Tivozanib in various combinations and dosing regimens in RCC and additional solid tumor indications, including breast cancer and colorectal cancer.

“We are conducting a number of clinical trials of Tivozanib both as single therapy and in combination with other anti-cancer agents, and we believe the drug may represent an important and differentiated new therapeutic option to treat RCC,” says Tuan Ha-Ngoc, president and chief executive officer of Aveo.

The European Medicines Agency has granted orphan status to Tivozanib for treatment of renal cell carcinoma. Orphan medicinal product designation is awarded by the EMA for drugs that are shown to diagnose, prevent, or treat life-threatening or rare, serious conditions.