An open letter to the Mirocals Consortium regarding the ongoing confusion over the ILTOO “managed access program” (= Expanded Access Program – EAP) for their new ILT-101 formulation (n.b. not for Proleukin as used in the Mirocals trial) and potential access to it for UK patients. The MND community is not receiving the communications it deserves on the Interleukin 2 drug candidate and only seek clarification. 

Dear All,

You will clearly have noted the Iltoo announcement of September 14 about its “managed access programme”. This is an open letter to members of the Mirocals consortium seeking clarification.

As already mentioned to some of you, this has caused confusion in the patient/carer ranks and potentially offers false hope. In many ways, it could be seen as deflecting interest away from efforts to gain access to the trial drug, Proleukin, once the trial data/report is published with a positive consensus, via NHS Specials and NHS Medicines Repurposing. We have asked Iltoo to explain more, but they have refused, simply pointing us to the announcement on their website and the information on their managed access programmes.

We are constantly being asked by fellow patients about this programme and how it compares with the possibility of accessing Proleukin. As mentioned above, we are unable to give any clarity and can only advise them to consult you and your neurologist colleagues.

But this then leads to a “Catch-22” situation, because the examples below of messages coming back to patients from their consultants are potentially misleading and certainly confusing.

As you are part of the MIROCALS Consortium, would it be possible for you to get some clarity from Iltoo on what their plans are?

They have announced it but there are no further details and we urgently need some clarification on exactly when this programme will start, is there a protocol, how extensive can it be etc. It seems from Nigel’s note to a fellow patient on Thursday that the programme is only open to previous trial participants. This is absolutely not clear from the announcement and another signal of false hope for patients.

We cannot emphasise enough the considerable consternation this is causing in the community, especially after the previous nine months of lack of clear communication. Concerns are being raised in many quarters that this situation is driven by commercial concerns, that it is “immoral” and not in the best interests of patients etc.

We know that you will wish to help and look forward to your earliest response.

With best wishes, Carol Anderson, David Setters, Emma Moss, Jennie Starkey, Lee Millard, Nicola McFarlane, Nicola Waters, Stephen Darby, Geoff Burrow.

Patient 1

Email from consultant to patient:

I am in the consortium but I do not control what information is released or know all the information. Managed access here means on a named patient basis. For the UK this involves availability for people in the original trial first. We then apply through the NHS Specials route for more widespread
access while formal regulatory approval is sought. So the first step is having our institutions let us prescribe to MIROCALS trial patients.

Patient 2

Response from a consultant to a patient/carer.

We will only give drugs fully licensed for MND, no early access programmes

Patient 3

There is work going on to make it available, but at the moment our permissions in the UK only allow us to prescribe to ex-trial patients. We are working with our pharmacy for wider approval and will let you know as soon as that happens. The issue as I understand it is not with the company or supply (though understand your concern about it being a small company). Without the local/national approvals in place then they (Iltoo) cannot take things further (as on their website), that is the issue. So even if they have your info, it will be blocked at the first hurdle.

Patient 4

I asked my MND nurse last week and she said they were only doing the access groups in America and Europe.

Patient 5

It says on the link the request must be unsolicited and following conditions apply. Unsolicited means not asked for or not wanted. I was also told by neuro that the only access to it will be as part of phase 3 trial and participants will be newly diagnosed only and there will be no other way to access this. If this is correct how can it be fair or obtainable to the MND community?

Patient 6

Today I received a call to say that despite the fact I took part in the MIROCALS clinical trial and the company who has bought the rights to manufacture and supply the drug, want to give me and other trial participants early access to IL2 on compassionate grounds, an NHS committee have decided that because the trial was in another. I am under a different NHS health board they won’t give permission to prescribe it. I’ve yet to speak to my health board. But it’s been indicated to me already that they are also not in favour.

Patient 7

Email from consultant to patient:

As far as I can gather the consensus is that patients wait for the full final result of the trial and the final outcome of the NHS England drug repurposing scheme, which may produce an approved/official protocol for the issuing and prescribing of the lower dose of this medication. I think the outcome of the trial will be known soon but at the moment in the UK it is not possible to currently give this medication – I’m sorry.