Oncorena has started a Phase I/II clinical trial of its drug candidate orellanine to treat individuals with advanced kidney cancer on dialysis.

Orellanine is being developed for organ-specific chemotherapy with curative potential for advanced kidney cancer patients who are undergoing dialysis because of kidney failure. 

In various preclinical models, orellanine showed to precisely exert great antitumour effects on metastatic kidney cancer.

Carried out at the Centre for Clinical Cancer Studies at Karolinska University Hospital in Stockholm, Sweden, the trial will enrol up to 40 subjects and could include participants from other European nations. 

It will analyse the safety, tolerability, pharmacokinetics, and signs of antitumour effects in treatment with orellanine’s synthetic form.

Subjects will be administered intravenous doses of orellanin in the trial with a dose-escalation part followed by a repeated dose expansion part.

As the trial subjects are dialysis-dependent, hemodialysis is provided in collaboration with a team at the Karolinska Hospital’s dialysis unit. 

The company noted that the study is being coordinated with a clinical research organisation that focuses on oncology trials.

Oncorena CEO Lars Grundemar said: “There is a great medical need for improved treatment options in patients with advanced kidney cancer undergoing dialysis. 

“We are looking forward to the important clinical development phase in this therapy area. It is our hope that the results from our clinical study will be of great benefit to patients in the future.”

In March last year, the Swedish Medical Products Agency granted approval for the trial of orellanine in patients with advanced kidney cancer undergoing dialysis.