The MIROCALS consortium is delighted to announce that the first participant has been recruited to the MIROCALS trial, at Hospices Civils de Lyon, France.
“We are very pleased to be entering the recruitment phase. Many of the other participating clinics in France and England are undergoing their final readiness checks and we expect the majority to be in a position to start recruiting in the coming weeks” said Scientific Co-ordinator Dr Gilbert Bensimon.
“When we initially set out plans for this trial we knew we were combining two of the most complex areas of medical science, neuroscience and immunology. It has been exciting to bring together such a diverse range of scientific expertise together from across Europe.
“We have also had to face considerable logistical and regulatory challenges in creating the platform for the trial, but are confident that these have been overcome and are looking forward getting on with the research.”
The MIROCALS trial, which will test whether low doses of the drug Interleukin-2 (IL-2) can alter aspects of the immune system, which may play a role in the speed at which ALS progresses. The drug is already used to treat some rare forms of cancer, but at much higher doses than will be used in MIROCALS. A pilot study, recently completed by Dr Bensimon and colleagues in France, indicates that low doses of the drug produce the desired effects on the immune system, whilst greatly reducing the possibility of side effects that have been seen with cancer treatment.
“We will be looking to recruit up to 216 participants to the trial” said Prof Nigel Leigh, Chief Trial Investigator for MIROCALS. “The recruitment will be phased over the next 12 months, as there is an intensive period at the start of the study which limits the numbers that can be recruited at any one time.
“In addition, participants will largely have been recently diagnosed, as an important requirement of the trial is that patients have not yet started to take the drug riluzole. We also believe that the best chance of seeing a positive effect is if we can catch the disease at a relatively early stage.”
Details of participating clinics in France and the UK are available here.