CONVINCING PRECLINICAL RESULTS
Severe systemic lupus erythematosus
A systemic disease
Lupus affects between 80,000 and 100,000 people in France according to the CNRS. With a prevalence of 1 case per 1,600 to 1 case per 3,200 according to Orphanet, it affects 160,000 to 300,000 people in the European Union.
It is a so-called "systemic" disease. This is because its symptoms are very variable and the disease can affect any organ or tissue, making it very difficult to diagnose.
In general, it affects the skin, joints, kidneys, brain, heart, lungs, or vessels. Its warning signs are not very specific, such as malaise, fever, fatigue, and muscle pain, which usually precede joint or skin involvement, before multiple complications appear.
Lupus is most common in women of childbearing age (in over 90% of cases) and the average age of onset of clinical disease is between 20 and 40 years.
Current treatment for Lupus, despite intensive research, is highly inadequate, with devastating side effects for temporary relief.
Evidence from 2 preclinical studies in mice
Positive results from two preclinical studies using arsenic trioxide.
At the Medsenic Scientific Council (August 2016), Professor François Rieger (CNRS-Neuroimmunology, President of Medsenic) and Professor Bernard Lauwerys (Clinical Immunology, Cliniques Saint Luc Brussels-Louvain) presented the results obtained on two mouse models with Lupus erythematosus without lympho-proliferation.
The results obtained on the MRL/lpr mouse model with spontaneous systemic Lupus erythematosus (Hooke Laboratories results), and the results obtained on the evolution of the disease progression in tri-congenic mice are in perfect agreement and show a major effect of arsenic trioxide. A clinical trial on Lupus nephritis can now be envisaged.
Phase IIa trial results
The phase IIa clinical trial for Lupus in France has established proof of concept of safety for the patient and efficacy on the course of the autoimmune disease.
This trial was coordinated by the Nantes University Hospital and took place in 5 reference and competence centres in France, with the collaboration of Professor Mohamed HAMIDOU - Head of the Internal Medicine Department.