About Clinical Trials
A critical part in the process of bringing new therapies to patients is the clinical development phase, where the new treatment is examined in clinical studies on patients. It typically takes more than ten years from discovery in the lab for a potential new therapy to gain market approval to allow for routine use in patients. Clinical development is the most time consuming, challenging, and expensive part of the research and development program.
Process
Every trial is governed using well-defined ethical and regulatory rules and standards to protect participant safety and scientific integrity of the results. For patients, participation in a clinical trial may provide access to potential new therapies.
Clinical studies conducted during clinical development generate very important information of the new treatment regarding clinical benefits and possible side effects.
Oncorena has completed all preclinical studies and has initiated a Phase I/II clinical study in 2022. This study, named Oncorella-1, will examine safety and tolerability as well as anti-tumor activity of different doses of ONC175 in metastatic renal cancer patients. See more about Oncorella-1 here.
Approval
Oncorena has received regulatory approval by the Swedish Medical Products Agency to start the first clinical trial of ONC175 in patients with metastatic renal cancer at Centre for Clinical Cancer Studies at the Karolinska University Hospital in Stockholm, Sweden. The company’s Phase I/II study was initiated in February 2022. The study will subsequently be expanded to other countries.
Please note that only a physician can determine if a patient would be eligible to be enrolled in a clinical trial or not. If a patient has questions about his or her medical condition or possibility to participate in a clinical trial, the patient must consult a suitable qualified healthcare professional in his or her country for medical advice and specific information.
