The TBI preclinical research program includes 3 different studies evaluating the protective effect of NeuroSTAT® in a TBI experimental model. TBI is an important unsolved problem in the medical field: nerve cell protection following moderate to severe brain trauma. There currently exist no approved treatments for this medical problem therefore ensuring there are appropriate studies which can evaluate the potential efficacy of a new treatment option is extremely important. PENN will provide NeuroVive with important data regarding the potential effect in this condition. These preclinical studies will complement the ongoing CHIC study which is evaluating NeuroSTAT® in clinical practice. The preclinical research program will provide additional preclinical data for NeuroSTAT® in the treatment of TBI to support the regulatory filings for the TBI registration.
“We are very pleased to begin these preclinical studies in collaboration with Drs. Susan Margulies and Todd Kilbaugh at the University of Pennsylvania and the Children’s Hospital of Philadelphia who are experts in TBI experimental models. The TBI research program is a priority for NeuroVive and we are putting extra efforts to progress both the preclinical program as well as the CHIC trial to ensure we understand the potential use of NeuroSTAT® in this serious medical condition” said Magnus Hansson, Chief Medical Officer of NeuroVive.
“After extensive preparatory work, we have now begun the first phase of the TBI program. It was important that we set up the first phase correctly as the findings of this will be critical for the next two phases of the TBI program. We have been working for several years to develop clinically relevant experimental models of TBI, and believe that the testing of novel pharmaceutical treatments in our models, such as NeuroSTAT®, will facilitate and improve the future clinical development of TBI,” commented Dr. Susan S. Margulies, Professor in Bioengineering and Neurosurgery at the University of Pennsylvania
Traumatic brain injury (TBI) is brain damage that occurs after an external trauma to the head, where nerve cells receive immediate damage. The injury deteriorates for several days after the accident, often leading to a significant impact on the overall injurious effect. TBI afflicts approximately 1.7 million Americans annually with more than 52,000 associated deaths and 275,000 hospitalisations. [i] Both direct and indirect costs associated with TBI are estimated at more than $60 billion with a high number of patients left with moderate to severe disabilities requiring intensive care and support. It is hoped that better treatments for TBI, such as NeuroSTAT®, will lead to increased survival and greatly improved outcomes in terms of the ability of patients to function normally following a severe TBI.
NeuroVive Pharmaceutical AB (publ) is a pioneer in mitochondrial medicine company committed to the discovery and development of highly targeted candidates that preserve mitochondrial integrity and function in areas of significant therapeutic need. NeuroVive’s business approach is driven by value-adding partnerships with mitochondrial research institutions and commercial partners across the globe. NeuroVive’s portfolio consists of two clinical projects in acute kidney injury (AKI) and traumatic brain injury (TBI), one candidate in preclinical development and two drug discovery platforms. NeuroSTAT® has orphan drug status in Europe and in the US for treatment of moderate to severe traumatic brain injury and is currently being evaluated in a Phase II study. CicloMulsion® is being evaluated in an on-going Phase II study, CiPRICS, in acute kidney injury during major surgery. NeuroVive’s shares are listed on Nasdaq, Stockholm, Sweden.
For investor relations and media questions, please contact:
Christine Tadgell, Tel: +46 (0)275 62 21 or email@example.com
It is also possible to arrange an interview with NeuroVive’s CMO Magnus Hansson at the above contacts.
NeuroVive Pharmaceutical AB (publ)
Medicon Village, SE-223 81 Lund, Sweden
Tel: +46 (0)46 275 62 20 (switchboard), Fax: +46 (0)46 888 83 48
NeuroVive Pharmaceutical AB (publ) is required to publish the information in this news release under The Swedish Securities Market Act. The information was submitted for publication on the 26 April 2016, at 8.30 CET.
[i] U.S. Centers for Disease Control and Prevention (CDC). National Center for Injury Prevention and Control. Injury prevention and control: traumatic brain injury. CDC website. Available at: www.cdc.gov/traumaticbraininjury/statistics.html.