The Pathway To Clinical Trials
Our vision for the first clinical trial in multiple sclerosis is on course for 2020, supported by a UK government funding award. These funds bring together four partners all working towards the common clinical goal. But there is still much to be done. Firstly, we must prepare the LIFNano particles in large amounts to meet required clinical standards set by the Regulatory Authority - an essential formality before treating people. Different countries have their own Regulatory Authorities, as for example the American FDA (Food and Drug Administration) and the European EMA (European Medicines Agency), and we have engaged professionals skilled in how to work with them. This helps communications and ensures we are all on the same "side" in the aim to start trials without any technical or procedural hitches.
A key part of regulatory approval is trial design - and our founder, Su Metcalfe, has brought together experts to form the "LIFNano Clinical Trial Panel" led by Gavin Giovannoni, an MS physician who is a world leading authority in MS trials. The panel is also generously supported by other experts including from the Pharmaceutical industry who are giving their time to help secure LIFNano's Trial approval. Recently, Bob Clay has joined us, President of TOPRA, an organisation who specialise in working with the FDA and the EMA (see link).
So, overall, you can see we are working with a world-class team to create a seamless path to clinical trials. https://www.lifnano.com/team/
Currently two trials are planned, the first Phase Ib, to confirm safety in patients. The second Phase IIa, looking for benefits in people recently diagnosed with MS. However, we also are fully aware of the needs of all MS sufferers. Therefore, there are other trials planned that may be fast-tracked, these will build on the knowledge gained from the initial trials, and will be guided by our expert panel