NZ-developed MS drug moves to second clinical trial
21 Aug, 2012
A New Zealand-developed drug to help people with chronic, progressive multiple sclerosis (MS) is having positive results according to the developers and overseers of the drug’s first round of clinical trials.
MS is a chronic, unpredictable neurological disease that affects the central nervous system. It is thought to be an autoimmune disorder, meaning the immune system incorrectly attacks healthy tissue. Symptoms may be mild, such as numbness in the limbs, or severe, such as paralysis or loss of vision. These problems may be permanent or may come and go.
Positive effect for many patients
In mid-June 2012, Auckland-based biopharmaceutical company Innate Immunotherapeutics reported that the drug – MIS416 – is being ‘well tolerated’ by patients and that the phase 1/2 clinical trial held in New Zealand was useful to identify a clinical dose for further evaluation.
In a press release, neurologist Professor Tim Anderson, co-principal investigator for the study, said the MS-related clinical status assessment tools used during the study also indicate that the drug may have had some positive effect for many of the treated patients.
“During the dose confirmation portion of the study, eight of 10 patients with secondary progressive MS treated with MIS416 for 12 weeks showed some improvement in their MS-related signs and symptoms.
”For example, 50% of the study subjects showed some improvement in EDSS [Expanded Disability Status Scale] scores over the relatively short 12-week duration of the trial. These interim results are encouraging and merit the consideration of a randomised, controlled trial in patients with secondary progressive multiple sclerosis,” says Prof Anderson.
Immune modulating microparticle technology
MIS416 has been developed using Innate Immunotherapeutics’ proprietary ‘immune modulating microparticle technology’. The technology is based on the use of a bacterially derived therapeutic microparticle with multiple naturally occurring ligands that, when administered, can activate innate immune signalling pathways to down regulate chronic inflammation, reduce autoimmune factors and help repair damaged tissue.
Phase 2B study to investigate sustainability of improvements
Final results from the current phase 1/2 study are expected in late 2012. Innate Immunotherapeutics then plans to enrol MS suffers in 2013 for a 12-month phase 2B study to investigate the sustainability of the improvements seen in the first study. It’s likely that most of the next trial will be conducted in Australia where more MS-sufferers are available to take part. Financial support offered by the Australian Government is an added incentive for the company, although, CEO Simon Wilkinson adds, “If we can get appropriate local support, it would be good to also have trial sites in New Zealand.”
Funding and collaboration
Some financial support to date has come from the Ministry of Science and Innovation. Other support has come from Fast Forward – a venture capital arm of the United States-based National Multiple Sclerosis Society. Fast Forward accelerates the development of treatments for MS by connecting university-based MS research with private-sector drug development and by funding small biotechnology/pharmaceutical companies to develop innovative new MS therapies and repurpose FDA-approved drugs as new treatments for MS.
Innate Immunotherapeutics is also collaborating with New Zealand and US universities that specialise in oncology research to conduct preclinical studies of MIS416 in other applications, including treatment vaccines for a number of different cancers.
Get news story: Multiple sclerosis drug trials
- 21 August 2012