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 the next step is to examine safety and tolerability as well as anti-tumor activity of different doses of orellanine in advanced kidney cancer patients in a Phase I-II clinical study.
Approval
Oncorena has received regulatory approval by the Swedish Medical Products Agency to start the first clinical trial of orellanine 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.
Phases of Development
Preclinical testing
An experimental therapy is first tested in the laboratory and in animal studies. After this preclinical testing, and only if shown to meet certain safety criteria and to have value as a potential new therapy, the drug candidate advances to clinical testing in humans.
Early clinical testing
In trials for new cancer treatments the initial patients included are usually advanced cancer patients. The aim for these studies is to understand safety and tolerability for the new drug. Doses and how the drug is metabolized by the patient is also studied. In addition, signs of clinical effect of the new drug are often analyzed, for example tumor shrinkage.
Pivotal trials
Pivotal clinical trials (typically Phase III) test the results of earlier trials in larger groups of patients to confirm the effectiveness and safety of the experimental therapy. These trials are often randomized, where patients will either receive the experimental therapy, placebo, or another therapy (a “comparator”), and “double-blinded,” in which neither the investigator nor the participant are aware if the therapy given is the true experimental therapy, placebo (medication with no active ingredients) or another therapy (a “comparator”). These trials are the basis for the application to register a new treatment.
Registration
Filing an application for registration with the country’s health regulatory authority is the next step in bringing a potential new treatment to patients.
For Caregivers
Oncorena has completed all preclinical studies and the next step is a Phase I-II clinical trial. The clinical Phase I-II trial protocol has been developed in collaboration with Karolinska University Hospital in Stockholm, Sweden.
Oncorena has received regulatory approval by the Swedish Medical Products Agency to start the first clinical trial of orellanine in patients with metastatic renal cancer at Centre for Clinical Cancer Studies at the Karolinska University Hospital in Stockholm, Sweden. The study will subsequently be expanded to other countries.
For more information and contact
If you have patients with advanced renal cancer who are on chronic dialysis and who may be eligible for inclusion in Oncorena’s clinical program, please contact clinicaltrials@oncorena.com.