Oncorena has achieved a significant milestone by administering the first treatment to a patient in their Phase I/II trial of the groundbreaking compound ONC175 (orellanine). This clinical trial focuses on patients dealing with the dual challenge of metastatic renal cancer and dialysis, and the initial treatment, conducted smoothly on August 8, took place at the prestigious Center for Clinical Cancer Studies within Karolinska University Hospital in Stockholm, Sweden. The primary objectives of the study encompass evaluating the safety, tolerability, pharmacokinetics, and the potential anti-tumor effects of ONC175.
“I am happy to announce the first patient, first treatment in our clinical phase I/II trial, Oncorella-1, with ONC175 (orellanine). This is a milestone for Oncorena accelerating our development plan since these patients are in need of more effective therapies.”
– Börje Haraldsson, CEO and CSO at Oncorena AB.
Known as Oncorella-1, this clinical investigation is being carried out in the same hospital where hemodialysis is provided, as the patients participating in the study are reliant on dialysis. The inaugural patient received a 30-minute infusion of ONC175, marking a significant step forward. In the coming autumn, more patients are poised to receive treatment, with a keen eye on their progress. Each patient’s condition will be assessed four weeks after the infusion, with recommendations for potential dose escalations to be provided by an independent Data Review Committee.
ONC175, the promising drug candidate at the center of this trial, boasts a unique mechanism of action and holds the potential to revolutionize treatment for individuals grappling with metastatic renal cancer and dialysis-dependent renal failure. Preclinical studies have already demonstrated that ONC175 is a highly selective, organ-targeted chemotherapy agent with formidable anti-tumor efficacy against metastatic renal cancer.
“It concerns a very different and unique medicine that is being tested here on patients with disseminated kidney cancer. We are very happy that the study is underway and we look forward to the results.”
– Jeffrey Yachnin, M.D. responsible for the study at the Center for Clinical Cancer Studies, Karolinska University Hospital.