New Zealand and Australia-based Innate Immunotherapeutics Limited, a medical biotechnology company with offices in Sydney and Auckland, has issued an update regarding its Phase 2B trial for secondary progressive multiple sclerosis (SPMS) and other recent activities.
The Phase 2B MIS416 trial Patient dosing with MIS416 is now underway at the West Australian Neuroscience Institute (WANRI) in Perth and at Nucleus Network’s AMREP Centre for Clinical Studies in Melbourne. Each site has dosed their first two patients with several more patients due to commence treatment this month. A Brisbane site, the Wesley-St. Andrew’s Research Institute (WSARI), will be initiated on November 12th and will start recruiting patients shortly thereafter.
A map of the currently active test sites in Australia is available here.
Following on from the commencement of the Phase 2B trial, the Company has made a key new appointment to its scientific staff. Dr Claudia Mansell has joined the Innate team as Senior Research Scientist to lead the analysis of trial subjects’ blood samples. The goal of this work is to develop tests that could be used to help monitor patients’ responses to treatment with MIS416. Developing such a test would be a significant achievement as there are currently no blood tests available to monitor the effects of disease or treatment in patients with SPMS.
Dr Mansell obtained her Ph.D. in Immunology at the Heinrich Heine Universität (Düsseldorf, Germany) and the Harvard Medical School (Boston, U.S.A) and has joined the Company from the School of Biological Sciences, University of Auckland (Auckland, NZ).
Innate Immunotherapeutics 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.
Thee two main forms of MS are an early “relapsing-remitting” stage of disease and a later, more disabling “secondary-progressive” stage of disease (SPMS). Thirty percent of the estimated 2.5 million MS sufferers worldwide have SPMS, and there are currently no approved disease modifying drugs for the safe and effective ongoing treatment of this disabling form of the disease, which causes walking, hand, eyesight, and cognitive function disabilities.
Innate Immunotherapeutics’ MIS416 experimental therapy for Secondary Progressive Multiple Sclerosis (SPMS) is a biologically derived novel immune modulator that can target both 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 primary goal of the current 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.
Innate says previous non-placebo controlled MIS416 studies found that 80% of patients with SPMS had shown a 30 percent or greater improvement in at least one measure of their MS-related symptoms. Patient stakeholder groups such as Multiple Sclerosis Research Australia (MSRA) and the United States National Multiple Sclerosis Society (US MS Society) have expressed strong support of Innate’s pursuit of an effective treatment for SPMS. The experimental medication has been studied and used as part of the ongoing compassionate use program in Australia, and revealed promising results in studies led by researchers at Victoria University of Wellington in which researchers demonstrated that MIS416, developed originally to treat the relapsing-remitting form of MS, is efficient in the treatment of secondary progressive multiple sclerosis as well. However, the research team has not fully understood what makes the therapy effective.
How MIS416 Works in Treating SPMS
The microparticle at the core of Innate Immunotherapeutics’ technology provides a unique delivery system for a suite of both known and novel immune system triggers or modulators. By attaching selected modulators to the microparticle, these triggers can be delivered reliably to specific cells of the immune system.
Target diseases or applications for drugs developed using this approach include:
• Auto-immune diseases such as Multiple Sclerosis;
• Certain cancers that are known to be immune-sensitive, such as prostate, colon, & renal cancer; and
• Preventive vaccines for malaria and tuberculosis, and therapeutics vaccines for cancers.
In vitro studies have shown that MIS416 has specific immunomodulatory effects on dendritic cell, monocyte / macrophage, Natural Killer (NK) and NKT-cell cytokine secretion patterns, in parallel with enhancement of a broad range of soluble and cellular tumouricidal mechanisms such as granule, Fas, TRAIL and TNF-a. Due to the significant degree of unmet medical needs, Secondary Progressive Multiple Sclerosis has been selected as the initial clinical target for MIS416.
Unlike most pharmaceutical agents (drugs or monoclonal antibodies), immunomodulators like MIS416 do not act directly on the target (cancer tumor, infectious agent, damaged nerve), but instead switch on powerful disease fighting mechanisms that form part of the human immune system. The immune system is a collection of biological barriers and processes that protects against disease by identifying and killing external threats such as infectious agents (bacteria, viruses, parasites, other pathogens) and internal threats such as cancer tumor cells. To function properly, the immune system needs to distinguish between threats and the body’s own healthy cells. When this ability to distinguish between non-self and self breaks down, the immune system can attack healthy cells resulting in one of several autoimmune diseases.
When administered as a distinct agent, Innate Immunotherapeutics says MIS416 is a potent activator of broad but well characterized innate immune responses. The immune system comprises several layers of defense. The first line of defense consists of physical barriers, such as the skin and mucous membranes that line the digestive, respiratory, and reproductive tracts. For infection to occur, pathogens must first breach this physical barrier. When such a breach does occur, the innate immune system is the next line of defense — ‘innate’ because all animals naturally possess it from birth. The surveillance cells of the innate immune system firstly recognize the signature (or pattern) of an invading pathogen and then activate appropriate attack cells or mechanisms to clean out the invader. This same surveillance and response process also works for cells that go bad, e.g. early stage cancer cells. If the innate system is overwhelmed, the adaptive immune system is triggered, providing the last, but often the most potent layer of immune defense. The cells that form part of the adaptive response (antibodies and killer T-cells) must be custom-made to match the pathogen and so the process is relatively slow, but once designed, these cells can be made in huge quantities to overwhelm the threat. Once the system is adapted to recognize and destroy a particular invader, it remembers that invader, and can then react more quickly next time the invader is encountered.
The innate system is pivotal to the successful operation of the entire human immune system. It recognizes trouble, provides an immediate general (or non-specific) defense and if required, gives permission to the adaptive system to respond. Importantly, it also regulates the overall reaction to ensure that the level of response is appropriate to the degree of the threat. By activating and/or regulating important innate system mechanisms, Innate Immunotherapeutics’ microparticle immunomodulator technology presents a new and effective way to safely fight infections, certain cancers, and to treat select autoimmune diseases.
For more information, visit the Innate Immunotherapeutics website at:
Western Australian Neuroscience Research Institute (WANRI)
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