Project description
Innovative technology for ischaemic stroke management
Stroke, the second leading cause of disability after ischaemic heart disease, is a medical emergency that can lead to lasting brain damage or even death. Despite available therapeutic options for stroke patients, the disease remains a significant burden with high mortality and morbidity rates. The EU-funded SMR project is developing a novel therapy for post-stroke care, based on a proprietary product made of synthetic polysaccharides mimicking the macromolecules of the extracellular matrix. The technology was tested in preclinical models and proved to be a promising neuroprotectant agent for stroke subjects, improving neuronal tissue repair once blood flow was restored. The project objective is to validate the clinical use of the technology and complete the regulatory steps to bring it to market.
Objective
Stroke is the 2nd cause of death and major handicaps in industrialized countries. At present, the only available treatment for ischemic stroke are thrombolysis and thrombectomy. However, very few patients are eligible, and it is therefore absolutely urgent to find an alternative.
RGTA® are synthetic polysaccharides, mimicking endogenous macro-molecules called heparan sulphates, that make up the biological networks in which our cells live and reproduce: the extracellular matrix.
We have recently investigated the neuroprotective potential of a novel specific RGTA® (OTR4132) at the preclinical level using a rodent model of transient focal cerebral ischemia The i.v. administration of OTR4132-MD elicited a reduction of 39,6% of the volume of infarction at 48 hours following the insult. Interestingly, this RGTA®-induced reduction of brain damage persisted up to the chronic stage and RGTA®-treated animals showed a significant improvement of functional recovery (motor and sensorial) when compared to control animals.
Translational stroke studies in rodent models have thus already demonstrated the beneficial effects of RGTA® in acute phase and, following additional preclinical studies in an independent laboratory, the project will be ready for next stages of its route to market introduction, including clinical validation and product registration. The objective of the SMR project is to translate experimental findings into medical innovation, leading to a quick benefit for stroke patients. Positive outcomes of the project will ultimately lead to the EU registration of OTR4132-MD injectable solution as a medical device or a drug and to its market introduction in Europe for the stroke indication.
Fields of science
Programme(s)
Funding Scheme
SME-2 - SME instrument phase 2Coordinator
75001 Paris
France
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.