A method for peritoneal dialysis in the rat has been developed. Renal cell carcinoma cell lines have been incubated with and without orellanine. Renal cell carcinoma has been transplanted to rats and orellanine treated animals have been compared to control animals. Primary cultures of fresh tumor tissue from patients operated for renal cell carcinoma (clear cell and papillary) has also been incubated with and without orellanine.

Orellanine induced a pronounced and concentration-dependent decline in viability in renal cancer cell lines from primary tumors and from metastatic lesions but not in control cells (umbilicus epithelium, hepatocytes, carcinoma of the breast). Orellanine induced apoptosis and tumor shrinkage in renal cell carcinoma transplanted to rats. Orellanine treated rats had 400% more necrosis in the tumor compared to controls. Orellanine induced a dose dependent decrease in viability of human kidney cancer cells (both primary tumors and mets) in vitro. Based on these findings a drug development programme has been launched based on chemically synthesized orellanine.

A phase 1 study is planned to study safety and effects of orellanine on patients in dialysis with metastatic renal cell carcinoma with resistance to other oncological treatment. The study will be launched early 2018 at Sahlgrenska University Hospital. Initially we will include Scandinavian patients only but since the patient group is limited, the aim is then to expand the study by including patients from other countries.

Orellanine is a potential treatment for renal cell carcinoma with a unique mode of action which will be evaluated in selected patients already on dialysis and with metastatic disease.