NeuroVive has launched a clinical trial programme to assess NeuroSTAT®’s potential to reduce secondary tissue damage in patients with traumatic brain injury (TBI), an area of huge medical need for which there are currently no approved pharmaceutical treatment options.
The first part of this programme is a Phase IIa clinical trial, expected to begin soon, and followed by a combined Phase IIb/III trial. The Phase IIa trial will evaluate the safety and pharmacokinetics of NeuroSTAT® in patients with severe TBI and will be the first prospective clinical study assessing NeuroSTAT® in this patient population.
In parallel with conducting the Phase IIa study, NeuroVive intends to work with the regulatory authorities in the US and Europe to develop the protocol for a combined Phase IIb/III study. This study will be designed to provide the first randomized data from a controlled clinical study with NeuroSTAT® in TBI patients.
In China NeuroVive is developing and commercialising NeuroSTAT® in partnership with Sihuan Pharmaceutical Holdings Group Ltd, one of the largest domestic pharmaceutical companies in China.
NeuroSTAT® acts to prevent the death of mitochondria in damaged neurons and the cascade of intracellular biochemical events that lead to secondary tissue damage following a traumatic brain injury. It is hoped that better treatments for TBI, such as NeuroSTAT®, will lead to better survival outcomes and greatly improved outcomes in terms of the ability of patients to function normally following a severe TBI.
For more information on the 3rd Annual Traumatic Brain Injury Conference visit www.tbiconference.com.
About NeuroVive Pharmaceutical AB (publ)
NeuroVive Pharmaceutical AB (www.neurovive.com) a leading mitochondrial medicine company is developing a portfolio of products to treat acute cardiovascular and neurological conditions through mitochondrial protection.
NeuroVive’s products are based on the cyclophilin inhibitor cyclosporine and work by preventing the death of mitochondria in distressed cells and the subsequent cascade of intracellular biochemical events that lead to secondary tissue damage following an acute cardiac or traumatic brain injury.
NeuroVive’s lead product is CicloMulsion®, the first cyclophilin inhibitor for the treatment of reperfusion injuries following stenting. CicloMulsion® is currently in a 1000 patient Phase III clinical trial evaluating its ability to reduce reperfusion injuries in patients with myocardial infarction.
NeuroVive is also developing NeuroSTAT®, a cyclophilin inhibitor, which is soon expected to enter a Phase IIa clinical trial in patients with severe traumatic brain injury. Both indications have huge medical need and for which there are currently no approved pharmaceutical treatment options. Both CicloMulsion® and NeuroSTAT® are special formulations of cyclosporine for use in acute cardiac and brain injury indications.
NeuroVive’s pipeline includes novel cyclophilin inhibitors and drug candidates that act on mitochondria to address energy regulation disorders.
NeuroVive´s shares are listed on the Swedish trading platform AktieTorget (www.aktietorget.se). The AktieTorget market is focused on emerging, entrepreneurial businesses through an electronic trading system supplied by the OMX Nordic stock exchange in Stockholm, Sweden.
Media and investor relations contacts
NeuroVive Pharmaceutical: Mikael Bronnegard
Phone No: +46 (0) 70 299 62 64
Citigate Dewe Rogerson: Nina Enegren / David Dible
Phone No: +44 207 282 1050