Oncorena announced that the FDA has approved the company's IND application to initiate the Phase I/II study Oncorella-1: A Phase 1/2, open label, single arm study on safety, tolerability and anti-tumor efficacy of orellanine treatment in patients with metastatic clear-cell or papillary renal cell carcinoma (NCT05287945, ONC001-CL-001).
In the study Oncorella-1, up to 75 patients with severe metastatic renal cancer requiring dialysis will be enrolled. These patients have exhausted their treatment options and ONC175 represents a potentially new first-in-class treatment for patients with urgent unmet medical need.
The study is currently being conducted at Karolinska University Hospital in Stockholm, Sweden.
Börje Haraldsson, CEO & co-founder of Oncorena comments: "This approval brings us closer to being able to evaluate the potential for this novel treatment in patients in desperate need for new and better options. We are excited to start the first US site, MD Andersson in Houston, Texas, where the study will be led by investigator Professor Nizar Tannir, a world-leading expert in renal cancer."
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