EU patent given to arsenic trioxide, aiming to treat RRMS
Supports MS clinical trials of therapy, found safe in other autoimmune diseases
A potential treatment of relapsing-remitting multiple sclerosis (RRMS), arsenic trioxide (ATO) has been patented in the European Union based on findings in preclinical studies.
Notice of an intent to grant patent EP18722530, titled “Method for treating relapsing-remitting multiple sclerosis using arsenic trioxide,” was given by the European Patent Office (EPO) to Medsenic, the therapy’s developer and a subsidiary of Biosenic. The patent covers various formulations and methods of action for ATO in treating RRMS and multiple sclerosis (MS).
“BioSenic’s new EPO patent, which will be granted for the 27 European countries, opens new perspectives in the attempt to control the pathological effects of … multiple sclerosis,” François Rieger, PhD, chairman and CEO of Biosenic, said in a company press release. “This new potential use of our drug is part of our efforts to provide a unified treatment for a number of diseases that fall within the realm of innate, adaptive and acquired immunity.”
Arsenic trioxide works to kill T-cells involved in autoimmune diseases
Medsenic previously obtained U.S. patent protection for its use of an ATO formulation in treating RRMS, valid until 2037, that also was based on the company’s preclinical work in an established MS mouse model.
ATO is a compound used as a chemotherapeutic agent, and it has anti-inflammatory and immunosuppressive effects. It works by triggering the death of abnormally active immune cells — namely, the T-cells that are involved in several autoimmune diseases. ATO induces T-cell death by increasing the cell’s oxidative stress, without affecting other immune system components, the company reports.
When a cell’s production of reactive oxygen species (byproducts of metabolism) cannot be controlled by its ability to eliminate them, an imbalance known as oxidative stress results that can damage and kill cells.
Both the U.S. and European patents were based on lab studies using the experimental allergic (autoimmune) encephalomyelitis (EAE) mouse model, known to mimic the inflammatory and degenerative characteristics of RRMS in people.
Researchers evaluated ATO’s effects in these mice on inflammatory process associated with MS, particularly in the early disease stages. They found that the therapy could “delay the onset and/or treat the inflammatory phase characterizing the RRMS form,” the patent states.
Therapy showed ‘acceptable safety’ in a Phase 2 trial in people with lupus
Biosenic has published data supporting ATO’s mechanism of action and its effectiveness as an immunomodulatory and anti-inflammtory agent in other diseases, including systemic sclerosis, an autoimmune disorder that affects connective tissue.
A previous Phase 2a clinical trial in people with systemic lupus erythematosus, another autoimmune condition, reported finding ATO, given as an intravenous (into-the-bloodstream) infusion, to have an “acceptable safety profile … and encouraging efficacy.”
Medsenic reported that it is developing and testing diverse ATO formulations — including intravenous and oral forms — for various applications, and it expects that the European patent will facilitate work supporting Phase 2 and 3 clinical trials in RRMS.
“The anticipated availability of an oral formulation combining arsenic with potentially other active ingredients puts Medsenic/BioSenic in a unique position to build on its recent clinical successes,” Rieger said.
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