New Zealand and Australia-based Innate Immunotherapeutics Limited, a biotechnology company with offices in Sydney and Auckland, has designed and manufactured a unique immunomodulator microparticle pharmaceutical technology. This technology can be used to induce the human immune system designed to fight certain cancers and infections, or modulate certain immune mechanisms implicated in autoimmune diseases such as Multiple Sclerosis (MS). They say the same technology can be used in designing better vaccines to potentially treat or prevent diseases such as influenza, cancer, malaria, or tuberculosis.
There are two main forms of MS: an early “relapsing-remitting” stage of disease and a later, more disabling “secondary-progressive” stage of disease (SPMS). Worldwide, 30 percent of all MS sufferers have SPMS, and there are currently no approved disease modifying drugs for the safe and effective ongoing treatment of this highly disabling form of the disease, which causes walking, hand, eyesight, and cognitive function disabilities.
Innate Immunotherapeutics is currently recruiting subjects in Australia who have Secondary Progressive Multiple Sclerosis (SPMS) for its phase 2B trial of its experimental therapy MIS416, a biologically derived novel immune modulator that can target both the regulatory functions and the defensive (pathogenic) functions of the innate immune system. MIS416 targets myeloid cells, a sub-set of innate immune cells not currently targeted by existing or other ‘in-trial’ MS drugs.
Myeloid cells have only recently been recognized as a significant potential therapeutic target in SPMS. Myeloid cells have the capacity to remodel the deregulated immune activity, which is an important part of the disease process in SPMS. These same cells, remodeled in the correct fashion, can also promote neuro repair pathways critical to slowing or reversing disability in SPMS.
The study, which is being administered by the Western Australian Neuroscience Research Institute (WANRI), was recently approved by the Bellberry Human Research Ethics Committees (HREC) — a national, private not-for-profit organization providing streamlined scientific and ethical review of human research projects across Australia — allowing the clinical trials to commence. HREC’s mission is to promote and improve the welfare of research participants and the quality, efficiency and effectiveness of the research itself.
In August, WANRI received approval to commence patient recruitment for Innate Immunotherapeutics’ Phase 2B trial of MIS416 in patients with SPMS. WANRI has been selected by Innate as the study’s lead site, due to its strong focus on investigating the causes and improving the therapy and management of patients suffering from multiple sclerosis. The Institute has a strong focus on providing the best clinical management for multiple sclerosis available.
“We are really pleased to be leading this trial. SPMS affects 30% of the MS population at any moment in time, and there are no approved long term effective treatment options for these patients. We all hope that MIS416 might be the drug to address this urgent need,” says Dr. Allan Kermode, clinical Professor of Neuroimmunology at WANRI.
The Phase 2B trial will recruit up to 90 SPMS patients with the secondary progressive form of multiple sclerosis across eight investigational trial sites in Australia. The trial is a double blinded randomized study, where 60 patients will receive MIS416 and 30 will receive a placebo. Patients will be treated once weekly for 12 months. The primary goal of the trial is to determine the efficacy and safety of MIS416 compared to patients treated with the placebo. As part of the study, patients will also report their own health status quarterly, as previous study results have shown significant and sustained reductions in pain and fatigue.
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