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Mirocals Update Feb 13th 2024

Here is our regular update on Mirocals. Our main Mirocals page has also been updated and, sadly, there is again effectively ‘no update’.

However, we always try to clarify things as far as we can. In this short post we discuss a concern we have as we follow the continuing saga and await the release of the results.

Let’s face it, we are all hopeful at the genuine possibility of an additional treatment being added to our only current therapy, Riluzole. However, if the trial is indeed successful, we have doubts about the speed at which patients will be able to have the essential conversation with their consultant as to how this treatment might help them, if they can access low-dose reconstituted Proleukin and how quickly. 

In a nutshell, we are concerned that any imminent regulatory application may be fundamentally flawed. Why?

The brand Proleukin is the form of Interleukin 2 (IL2) used in the Mirocals trial and is the ONLY commercial and medical grade IL2 available globally. It is already approved for specific cancers by the NHS. It sits in vials on NHS pharmacy shelves.

However, the rights to bring to market (using the data from the Mirocals trial) a NEW low dose product treatment were sold to ILTOO in 2023 and it has been made clear that any regulatory application in the event of a successful trial would be for this new, undeveloped and, as yet, non commercial product.

Please note Proleukin is already available and could be prescribed, we believe, in its low-dose reconstituted IL2 form as an NHS Special if the results are positive. The ILTOO acquisition simply applies to the rights to market a NEW version.

This ILTOO drug, designated with the name ILT-101, is known as a “bio-similar”. Here’s our best stab at explaining what that means.

IL2 (eg Proleukin) is a drug NOT produced by chemical synthesis (such as aspirin, paracetamol and Riluzole), but by biological processes, eg using bacteria to manufacture in what we might call a biological ‘soup’.

As a result, there can be significant manufacturing differences that could affect both safety and efficacy. This is unlike so-called generic drugs, eg riluzole, which are chemically synthesised by many pharma and considered identical by regulators.

With respect to the Mirocals trial, we understand that a regulatory application is being proposed, in the event of a positive outcome, for ILT-101 and NOT Proleukin.

But ILT-101 is untested for MND and not used in the trial! How does this tally?

Is it possible for the MHRA/EMA to approve a new “bio-similar” drug when NO IL2 reference product (RP) for MND has been approved previously? 

Here are the MHRA Bio-similar rules for regulation. Note the following lines..

“… Reference product (RP) must be (or have been) licensed…”

It appears, to we amateurs, that a bio-similar cannot be approved if there is no reference product (RP) for MND already approved. Given that the trial used Proleukin, it suggests that the MHRA would simply reject an application for ILT-101 in the short term?

We accept, however, that our reading of the regulations may lack sufficient insight and experience to justify these concerns. They may be entirely unfounded. Without clarification, however, the regulations seem subject to interpretation.

This is why, if the results are positive, we will be focusing on the NHS Specials and drug repurposing routes (answer 4 on our primary Mirocals page) for reconstituted Proleukin. We strongly fear that the MHRA/EMA will mandate a new trial on the new product ILT-101.

This is yet another area that needs explanation. Given the ongoing lack of communication from the Consortium and ILTOO, we will continue to dig for answers as we await the results.

Best wishes

United2endmnd