The trial, which is being conducted by the Hoosier Oncology Group, is open for enrollment at the Baylor Sammons Cancer Centre, Dallas, Texas; Indiana University Melvin and Bren Simon Cancer Centre, Indianapolis; and the Cancer Treatment and Research Centre, University of Texas, San Antonio, Texas.
The trial will determine whether BNC105 is effective in the treatment of progressive metastatic renal cell carcinoma, either in combination with or following Afinitor (Everolimus) treatment in patients, who have disease progression following treatment with tyrosine kinase inhibitors such as Sutent or Nexavar.
Deborah Rathjen, CEO and managing director of Bionomics, said: “We are pleased to be working with such an experienced clinical consortium as the Hoosier Oncology Group to conduct this trial across multiple sites throughout the US. Metastatic renal cancer has a poor prognosis and there exists a real need for new therapies despite relatively recent advances in treatment. It is encouraging that a renal cancer patient enrolled in the Phase I study of BNC105 conducted in Australia under an IND application to the FDA showed clinical benefit.
“In addition to the potential clinical benefits of BNC105, we believe that renal cell cancer offers a strong market opportunity for BNC105 if successfully developed. Worldwide sales of Sutent were $847m in 2008, whilst reported sales of Nexavar in 2008 were $677.8m. Sales projections for Afinitor, which gained marketing approval in the US and Europe in 2009 for the treatment of renal cancer, exceed $500m.”