Clinical Trials

SentoClone AB carries out clinical trials aiming to evaluate the patented immunotherapy clinically on different forms of cancer. In our clinical trials we cooperate with large and small hospitals in Sweden.

SentoClone AB's ongoing clinical trials are approved by the Ethical Review Board and the Medical Products Agency.

The clinical trial that is currently under way is a study on metastasised malignant melanoma.

Under the headlines in the left column you can read more about SentoClone AB's ongoing, planned and previous clinical trials.

What is a clinical trial?
The principal aim of a clinical trial is to evaluate safety and efficacy of a medical product. At the same time one wants to evaluate if the medical product is reliable and that side effects are acceptable in proportion to the effect.

Clinical trials are usually divided into four phases:
Phase I
In Phase I the medical product is tested for the first time on human beings. The most common aim is to find out how the substance is converted in the human body. In this phase the medical product is often tested on a small group of healthy, voluntary persons, as the effects on human beings are completely unknown.

Phase II
In Phase II the medicinfal product is given to a larger group of patients that suffer the affection. The aim is to efvaluate if the medicinal product has the intended effect and in which dosage the medicinal product should be given. After completion of this phase the common side effects that can be connected to the tested product are known.

Phase III
Phase III is conducted on a large group of patients where patients differ in age, weight and sex. The aim is for the patient group to reflect the composition of the population that the finished medicinal product is intended for. In Phase III the medicinal product is compared to placebo (an inactive substance) or already approved standard treatments for the affliction. After this Phase an application to have the medicinal product approved can be submitted to the Regulatory Authorities.

Phase IV
Phase IV studies are conducted after the medicinal product has been approved and is on the market. The product continues to be evaluated and compared to other therapies on a large scale for as long as it is marketed. The aim is to get knowledge of the long-term effects and possible rare side effects that have not been discovered during the previous trials.

The patient in clinical trials
When a patient joins a clinical trial the responsible physician informs the patient of all examinations and visits involved with the study. There is a special protocol, which describes the clinical trial that the doctor should follow. Before the patient agrees to join a clinical trial a consent form is signed. The patient can withdraw consent and leave the clinical trial whenever he or she wants.

Last Updated Friday, 18 December 2009 12:40