Earlier in the year we announced some exciting preliminary results from a phase 1 clinical trial into a novel therapy for progressive MS. Professor Michael Pender from the University of Queensland and Professor Rajiv Khanna from QIMR Berghofer Medical Research Institute lead a study into a new therapy called autologous EBV-specific adoptive immunotherapy.
In this trial specific cells from the immune system (T cells) were isolated from an individual’s blood. These cells were then exposed to a vaccine for Epstein Barr Virus (EBV) which has been shown to re-target and focus the T cells so they can more effectively kill EBV infected cells. These newly fortified T cells were then injected back into the person.
This therapy is called autologous immunotherapy, because the immune cells are obtained from and returned to the same individual, whereas if the cells were donated from a different individual it would be called allogeneic. The phrase immunotherapy indicates that it is a therapy that enables your own immune system to fight off its target, in this case EBV.
This trial has arisen out of Professors Pender’s extensive fundamental research into the role EBV plays in MS. Professor Pender’s work and the work of other scientists have shown that EBV plays an important role in the development of MS. While EBV is a common infection in the general public, with between 90-95% of people being infected, it is thought that 100% of people with MS are infected. While EBV is associated with glandular fever (also known as infectious mononucleosis) in adolescents, in most cases it causes just a general non-specific viral illness, usually in children, resulting in most people not realising they have had a previous infection.
Professor Pender and his team have previously shown that there are differences in the immune system in people with MS compared to people without MS, especially when it comes to controlling EBV infection. They hypothesised that targeting EBV infected cells in people with MS might help combat the disease.
While the full results have not yet been released from the trial, it has been reported that six out of the ten people with progressive MS treated (both primary and secondary progressive MS) showed signs of clinical improvement. It is important to note that this was an early trial and it was primarily designed to test the safety of the treatment, and not the efficacy of the treatment. No serious side effects were reported. Whilst this was a very early clinical trial we are cautiously optimistic. Going forward this treatment will be referred to as ATA190.
Atara Biotherapeutics have just released a press release stating that they have initiated a new multinational, multicentre Phase 1 clinical study to evaluate allogeneic immunotherapy in patients with progressive or relapsing-remitting MS. This is a very similar treatment, but the term ‘allogeneic’ indicates that the EBV-targetting T cells have come from a different donor person. This treatment is referred to as ATA188.
The primary objective of this clinical trial is to assess the safety of allogeneic immunotherapy for at least 1 year after the first dose. At the same time they will be examining improvement or halting of MS progression.
The trial is expected to enrol a total of 60 patients; 30 patients with progressive forms of MS, and 30 patients with relapsing-remitting MS (RRMS) across Australia, the USA, and Europe. More information about the Australian arm of the study will be made available shortly on the www.mstrials.org.au website.
MS Research Australia is proud to have supported Professor Pender and his team since 2005 right from the laboratory research stage through to helping fund their first human trial of the autologous therapy. Over the 12 years MS Research Australia has awarded over $1.2 million to this group which has culminated in this very encouraging clinical trial tackling the toughest problem in MS – progressive disease.