Designation paves way for wider applications for several neurodegenerative diseases
The European Union has granted stem cell specialist Neuroplast an orphan medicinal product designation for the applicability of its stem cell technology platform to frontotemporal dementia (FTD), following a positive opinion from The European Medicines Agency (EMA).
With an existing orphan disease designation for traumatic spinal cord injury, Neuro-Cells is now approved for a fast-track development pathway with market exclusivity for both a trauma-induced and chronic degenerative central nervous system disorder.
This marks an important milestone in the development path of Neuroplast’s Neuro-Cells platform – particularly as a stepping stone to other chronic neurodegenerative diseases such as Alzheimer’s and Parkinson’s Disease.
Furthermore, the potential width in therapeutic applicability of the Neuroplast technology gives perspective to millions of people suffering from neurodegenerative diseases that currently have no outlook on effective treatment.
Several conditions of the central nervous system – even when they seem unrelated – have similar underlying disease mechanisms in common. Neuro-Cells addresses each disease mechanism by moderating inflammation of damaged cells in the central nervous system, to limit further impairment. The treatment objective in acute disorders is to limit impact of sudden injury, whereas the treatment objective in chronic disorders is to limit progression of the disease.
Neuroplast is already running a fast-track development pathway for traumatic spinal cord injury (TSCI), with a phase 2 clinical trial in progress. This designation for frontotemporal dementia illustrates the broader applicability of the same technology for acute as well as chronic neurodegenerative disorders, paving the way to explore further applicability to other conditions.
Neuroplast CEO, Johannes de Munter, explained: “This designation for frontotemporal dementia is an important milestone in expanding the Neuro-Cells development to a wider range of therapeutic areas. Using the same technology platform for traumatic spinal cord injury and frontotemporal dementia, illustrates an unusual range of acute and chronic neurological disorders that could potentially benefit from this.”
