10 August 2023 Research
Our work under the umbrella of the MND Access to Treatments Taskforce is continuing at pace, with our focus very firmly on how we can support people with MND to access potential treatments at the point where positive trial results are published.
As you know from our weekly updates, our attention at the moment is on the MIROCALS study into Interleukin-2. With the help of a team of experts we are investigating and identifying early access routes to low-dose IL-2, which is currently unlicensed, and also navigating any potential barriers to gaining access. We want to make sure that, should the anticipated trial data prove positive, the drug is made available at the earliest opportunity.
We’ve had a number of discussions around this - some helpful, some less so.
As background, Proleukin was the version of IL-2 purchased for the MIROCALS trial. At that time, the drug was owned by Clinigen Ltd.
In January of this year, Clinigen sold the worldwide commercial rights to a company called Iovance Biotherapeutics, based in the USA.
We have met with Iovance and they have assured us there would be no disruption to the supply of Proleukin in the UK. When the MIROCALS data is published, and if the results are positive, there should be no barrier to availability of Proleukin for compounding into a low-dose formulation.
The next stage is the compounding of the drug. Compounding is the pharmaceutical process of combining, mixing or altering a drug for specific use. While Proleukin is approved for use in certain cancers, its high dose can affect the body very differently from low dose – it’s the low dose version which has been tested in the trial. Iovance does not have the capability to compound the drug.
We set up a meeting with Target Healthcare, a company which supplies drugs via the NHS Specials route to discuss if it could compound the drug. The answer was yes. Target Healthcare has confirmed it has the ability and capacity to compound the drug to a low dose formulation.
So we now know that, should the trial results prove positive, the drug will be available in the formulation necessary. The next stage would be getting that to patients. We’re already in discussion with the 22 MND Care Centres and Networks we help fund about how they would support patient access to the treatment. These are vital conversations which cover several important aspects, including funding, resourcing and training. We will keep you updated as those conversations progress.
In the meantime, the taskforce has identified the potential for Proleukin to be considered under the NHS England Drug Repurposing Scheme. The programme identifies and progresses opportunities to use existing medicines in new ways.
We held an informal meeting with the Head of the NHS Drug Repurposing Scheme.
Following that, we have been advised that because there is an intention to licence low dose IL-2 for ALS (the most common form of MND) by ILTOO Pharma the repurposing of Proleukin doesn’t fit within the criteria of the drug repurposing scheme.
This means ILTOO Pharma will need to submit its formulation of low dose IL-2 to the regulators in the UK, including MHRA and NICE, a process which we know can be very time-consuming.
We are disappointed by the initial advice from the medicines repurposing programme. We plan to meet with the Head of the scheme so we can better understand their eligibility criteria and consider possible ways forward.
People with MND don’t have time to wait and we are doing everything in our power to prevent delays, including challenging unnecessary barriers.
Chris James, Director of External Affairs
Footnote: This update has been amended on 17 August 2023 in line with more recent conversations with NHS England Drug Repurposing Scheme. You can read more by clicking this link.
Further Reading:
NHS England Drug Repurposing Scheme
Previous statement on access to treatments from Dr Brian Dickie