The phase IIa trial is an open label, uncontrolled study that will recruit a total of 20 patients. The primary endpoint of the study is to evaluate NeuroSTAT®´s pharmacokinetic properties and safety in patients with severe traumatic brain injury. In addition, secondary endpoints include several monitoring techniques to study the effect of NeuroSTAT® at the mitochondrial level and how different biochemical processes are influenced by NeuroSTAT® after a brain injury has occurred.
Traumatic brain injury is an area of huge medical need for which there are currently no approved pharmaceutical treatment options.
Mikael Brönnegård, CEO of NeuroVive Pharmaceutical said: “The inclusion of the first patient in our phase IIa trial to evaluate NeuroSTAT® for traumatic brain injury is an important milestone for NeuroVive. The study is designed to generate safety data and dosage information for the treatment of traumatic brain injury. This data will be vital for the upcoming phase III study with the purpose of evaluating NeuroSTAT®´s treatment potential for traumatic brain injury. The design work and planning of the phase III study have already begun.”
Bertil Romner, Professor of Neurosurgery, added: “I am glad to take part in the development of a long-awaited pharmacological treatment for patients suffering from traumatic brain injury, a disease with highly unmet medical need.”
More detailed information on the Phase IIa study can be found by accessing the following link:
www.clinicaltrials.gov/ct2/show/NCT01825044
About NeuroVive
NeuroVive Pharmaceutical AB, a leading mitochondrial medicine company, is developing a portfolio of products to treat acute cardiovascular and neurological conditions through mitochondrial protection. These medical conditions are characterized by high medical needs and that there are currently no approved pharmaceutical treatments options. NeuroVive´s products CicloMulsion® (heart attack) and NeuroSTAT® (traumatic brain injury) are currently being evaluated in phase III and phase II-studies, respectively. NeuroVive´s research programs also include a product for the treatment of brain injury in stroke patients and drug candidates for cellular protection and the treatment of mitochondria-related energy regulation diseases. NeuroVive´s shares are listed on the NASDAQ OMX stock exchange in Stockholm, Sweden.
Media and Investor Relations-related questions are referred to:
Ingmar Rentzhog, Laika Consulting, Tel: +46 (0)46-275 62 21, Email: ir@neurovive.com
It is also possible to book an interview with CEO Mikael Brönnegård or CSO Eskil Elmér via the contact information above.
NeuroVive Pharmaceutical AB (publ)
Medicon Village, SE-223 81 Lund
Tel: +46 (0)46-275 62 20 (operator), Fax: +46 (0)46-888 83 48
info@neurovive.com, www.neurovive.com
Current status for NeuroVive´s products
CicloMulsion®
NeuroVive´s product CicloMulsion® is the first cyclophilin inhibitor developed for the treatment of reperfusion injury. The potential of the product as a treatment for heart attack patients is currently being evaluated in a clinical phase III study with 972 patients.
NeuroSTAT®
NeuroVive is developing NeuroSTAT® for the treatment of patients with traumatic brain injury. NeuroSTAT® is currently being evaluated in a clinical phase IIa-study with 20 patients. The designing and planning of a phase III study has been initiated. NeuroSTAT® has been granted Orphan Drug Designation in both the US and in Europe for the treatment of patients with moderate and severe traumatic brain injury. The Orphan Drug Designation guarantees NeuroSTAT® market exclusivity in the US for seven years and in the EU for ten years after the product attains marketing authorization.
Other products
More information about NeuroVive´s product portfolio can be found on http://www.neurovive.com/Research–Development/Our-products/
NeuroVive Pharmaceutical AB (publ) is obligated to publish the information contained in this press release in accordance with the Swedish Securities Market Act. This information was provided to the media for publication 08:15 a.m. CEST on June 5, 2013.