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04-Sep-2023

Oncorena’s First Patient Treated with ONC175 (orellanine) in clinial phase I/II trial in Patients with Metastatic Renal Cancer and Dialysis at Karolinska University Hospital in Stockholm, Sweden

Oncorena’s First Patient Treated with ONC175 (orellanine) in clinial phase I/II trial in Patients with Metastatic Renal Cancer and Dialysis at Karolinska University Hospital in Stockholm, Sweden

LUND, SWEDEN, September 4, 2023 – Oncorena announces first patient treated in the Phase I/II trial of the first-in-class compound, ONC175 (orellanine), in patients with metastatic renal cancer and dialysis. The first treatment was conducted on August 8 without any complication at the Center for Clincal Cancer studies at Karolinska University Hospital, Stockholm, Sweden. The study examines safety, tolerability, pharmacokinetics and antitumor effect when treated with ONC175.

”I am happy to announce first patient, first treatement 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”, said Börje Haraldsson, CEO and CSO at Oncorena AB.

The clinical study, Oncorella-1, is conducted at the Center for Clinical Cancer Studies at Karolinska University Hospital, Stockholm, Sweden. Hemodialysis is given at the same hospital, since patients eligible to the study are dialysis-dependent. Now, the first patient was given an infusion of ONC175 for 30 minutes. Additional patients are ready for treatment in the autumn. Each patient is followed up four weeks after the infusion by an independent Data Review Committee recommending potential dose escalations.

The drug candidate ONC175 has a unique mode of action and is being developed as a potential cure in patients with metastatic renal cancer and dialysis-dependent renal failure. Prelinical studies have shown that ONC175 is highly selective organ-targeted chemotherapy with potent anti-tumor effects 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, says Jeffrey Yachnin, M.D. responsible for the study at the Center for Clinical Cancer Studies, Karolinska University Hospital.

 

This Press Release concerns a drug candidate under development. It does not attempt to communicate any conclusions reagrding effect or safety. It is the purpose of clinical trials to objectively assess safety, tolerability and effects of drug candidates. There is no guarantee that the drug candidate’s development program will be ompleted or that it will gain approval by relevant authorities.

For more information, please contact
Börje Haraldsson, M.D., Ph.D., CEO, and CSO Oncorena AB
E-mail: borje.haraldsson@oncorena.com
Phone: +46 70 267 9544

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Last Updated: 04-Sep-2023