MIROCALS update – September 2024

As we enter September 2024, the data from the MIROCALS clinical trial has still not been submitted to an academic journal for publication, which would make the data available for the public and researchers worldwide. 

It is now more than three years since the trial officially closed. This week, MND Scotland sent a letter to both the EU Clinical Trials Register and the Ethics Committee at Centre Hospitalier Universitaire de Nīmes, the MIROCALS trial sponsor, informing them of the delays to publication and expressing our disappointment at the time it has taken to make the data available. 

The MIROCALS trial tested a low dose reformulation of an existing drug – Aldesleukin, currently used to treat kidney cancer – in a phase 2 clinical trial that involved participants from across Europe, including the UK. The trial officially ended in July 2021 and top-line data was announced at a scientific meeting in December 2022. 

It is important that clinical trial data is published, so that a clinical consensus can be formed on whether the treatment tested is of benefit to people with MND. The expectation is that data will be made public within a year of a trial closing. This timeframe is recommended by the World Health Organisation, and required by the UK NHS Health Research Authority, and the clinical trial registries in the EU and the USA. 

Because this timeframe has been substantially exceeded, we have written to the EU Clinical Trials Register and the sponsoring institute ethics committee, to notify them of the situation and seek their intervention in encouraging publication. 

We feel that these ongoing delays are unacceptable – people with MND do not have time to wait. 

While this letter has been submitted by MND Scotland, we remain committed to working in collaboration with the other major UK MND charities to pursue every avenue available to us.