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The Swedish Medical Products Agency approves Oncorena’s Phase 1/2 trial

renal cancer

Oncorena has announced the Swedish Medical Products Agency’s approval of the Phase 1/2 of First in Patient trial of the compound orellanine in patients with metastatic renal cancer in dialysis.

Preclinical evidence shows that orellanine, a well known fungus toxin, specifically exerts powerful anti-tumor effects on metastatic renal cancer in different preclinical models, states the company in its press release.

“Evaluating orellanine in patients with metastatic renal cancer is a key milestone in our efforts to demonstrate the clinical features of this promising compound,” said Lars Grundemar, Chief Executive Officer of Oncorena.

About the clinical Phase 1/2 trial

The Phase 1/2 multicenter, open-label, clinical trial of orellanine, to be conducted at the Centre for Clinical Cancer Studies at the Karolinska University Hospital, Stockholm, Sweden, will enrol patients with metastatic renal cancer already on dialysis due to renal failure. Orellanine will be given intravenously.

The trial is divided into a dose escalation part followed by a repeated dose expansion part to examine safety, tolerability, pharmacokinetics and signs of anti-tumor effects. The Phase 1/2 trial will include up to 40 patients and will be expanded also to other countries.

Photo: iStock