On September 4, 2023 Oncorena reported 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 (Press release, Oncorena, SEP 4, 2023, View Source [SID1234634865]). The first treatment was conducted on August 8 without any complication at the Center for Clinical Cancer studies at Karolinska University Hospital, Stockholm, Sweden. The study examines safety, tolerability, pharmacokinetics and anti-tumor effect when treated with ONC175.

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"I am happy to announce 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," 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. Preclinical 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 regarding 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 completed or that it will gain approval by relevant authorities.

About ONC175

ONC175 with its new and unique mode of action, is being developed for organ-specific chemotherapy with curative potential for patients with metastatic renal cancer. ONC175 is the synthetically produced drug product, which active component is orellanine. Orellanine is found in mushrooms of the Cortinarius family. These can accidentally be picked and eaten as they are mistaken for funnel chanterelles. The clinical effects of orellanine are well documented and highly specific for kidneys. ONC175 is expected to have effects on the two most common forms of renal cancer, i.e., the clear cell och papillary types, representing approximately 90 percent of cases.

About the Phase I/II clinical trial

The Phase I/II clinical trial of ONC175 (orellanine), Oncorella-1, enrolls patients with metastatic renal cancer on dialysis due to renal failure. The study is conducted at the Centre for Clinical Cancer Studies at the Karolinska University Hospital in Stockholm, Sweden, and studies safety, tolerability, pharmacokinetics and signs of anti-tumour effects in treatment with ONC175. The Phase I/II trial will include up to 40 patients and may include patients from other countries.

About kidney cancer

Approximately 400,000 patients are affected by kidney cancer globally according to the WHO. The disease can often be cured by surgery if detected early, but the prognosis is less favourable if there are metastases. Today, the disease is treated with various types of targeted and immuno-active drugs, that seldom are curative. There is therefore a great and urgent unmet medical need for new, effective and safe drugs.