Clinical Trials

Date: 2015-05-14

Type of information: Publication of results in a medical journal

phase: 2

Announcement: publication of results in Neurology

Company: Neurovive Pharmaceutical (Sweden)

Product: NeuroSTAT® (cyclosporine)

Action mechanism:

immunosuppressive agent. The active ingredient cyclosporine acts by preventing the death of mitochondria in damaged cells and the following cascade of intracellular biochemical events that lead to secondary tissue damage. By protecting a cell's mitochondria, NeuroVive's products ensure that energy production is preserved and a damaged cell's normal regenerative mechanisms can act to repair and maintain the cell.

Disease: acute ischemic stroke

Therapeutic area: Cerebrovascular diseases

Country: France

Trial details:

Latest news:

• On May 14, 2015, Neurovive Pharmaceutical announced that published data indicates protective effect of cyclosporine in patients with stroke. The results of a clinical phase II study indicating that cyclosporine counteracts brain injury in a subset of stroke patients undergoing thrombolysis has been published in an article co-authored by one of NeuroVive’s research partners, professor Michel Ovize of Hospices Civils de Lyon (HCL). The French phase II study investigated the neuroprotective effect of cyclosporine, the active substance in NeuroVive’s product NeuroSTAT®, in 127 stroke patients who also received thrombolysis treatment (to reinstate the occluded blood flow) in the period 2009-2013. For all patients included in the study, the extent of brain injury was 24% lower in the cyclosporine group which was not statistically significant. In a smaller sub-cohort of patients with blood clots in major arteries (proximal occlusion) and where thrombolysis had been successful, however, cyclosporine demonstrated a statistically significant reduction of as much as 69% of the volume of brain injury compared to placebo. No differences were observed between the groups in terms of behavior or neurological function three months after treatment.
The results are outlined in the article Cyclosporine in acute ischemic stroke by Professor Norbert Nighoghossian, Professor Michel Ovize and other participants in the multicenter trial. The article was published in Neurology.