“We are delighted to add NeuroVive as an industrial partner to TRACK-TBI. The promising results with NeuroVive’s TBI candidate drug NeuroSTAT has garnered our attention. Partnering with companies such as NeuroVive is essential to our overall goal of accelerating the process of translating advances in TBI research into successful and much needed patient treatments,” said Geoffrey Manley, MD, PhD and Contact Principal Investigator TRACK-TBI.
NeuroVive’s TBI drug NeuroSTAT is currently in phase II clinical development. NeuroSTAT has shown a good safety and pharmacokinetic profile in a recently completed phase II study in TBI patients conducted at Rigshospitalet in Copenhagen, Denmark. Furthermore, neuroprotective effects have been demonstrated in experimental studies done at the University of Pennsylvania. NeuroVive plans to initiate an innovative NeuroSTAT phase II clinical efficacy study in TBI patients in 2018. The clinical trial design will leverage ongoing transformative development in the TBI research field by TRACK-TBI investigators and others.
“We are very pleased and proud to announce our collaboration with TRACK-TBI. TRACK-TBI’s mission to transform the clinical trial landscape in TBI and our collaboration will provide important support to our precision-based patient selection and treatment effect evaluation approach. The collaboration not only grants us access to the world’s top TBI clinicians and researchers, it also validates the quality of our NeuroSTAT development activities in the TBI field and will facilitate our goal to deliver a medicine that protects the brain of TBI patients in the acute stage,” said NeuroVive CEO Erik Kinnman.
The information was submitted for publication, through the agency of the contact person set out below, at 08:30 a.m. CEST on 2 May 2018.
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Traumatic brain injury (TBI) is caused by external violence to the head resulting in immediate damage to nerve cells. The damage continues to worsen for several days after the trauma, which in many cases has a significantly negative effect on the overall injury. At present, there are no approved treatments for the prevention of these secondary injuries. In the US, some 2.2 million people are affected annually, causing more than 50,000 deaths and 280,000 hospitalizations. The direct and indirect costs associated with TBI are an estimated USD 60 billion, and a large number of patients suffer moderate to severe functional disabilities requiring intensive care and various forms of support (www.nih.gov). The aim is that better preventive therapies for secondary brain damage, such as NeuroSTAT, will lead to higher survival rates, and significantly improve quality of life and neurological function of patients post-TBI.
TRACK-TBI, Transforming Research and Clinical Knowledge in TBI, was initiated to advance the research into TBI, traumatic brain injury, by improving TBI classification for targeted clinical treatment studies and TBI outcome assessments, thus reducing the size and costs of clinical studies. TRACK-TBI is currently running an observational study funded by NINDS collecting and analyzing detailed clinical data on subjects at 18 U.S. sites, across the injury spectrum, along with CT/MRI imaging, blood biospecimens, and detailed clinical outcomes which to date has enrolled 2,700 TBI patients. Further information can be found on https://tracktbi.ucsf.edu
NeuroVive Pharmaceutical AB is a leader in mitochondrial medicine, with one project in clinical phase II development for the prevention of moderate to severe traumatic brain injury (NeuroSTAT®) and one project in clinical phase I (KL1333) for genetic mitochondrial diseases. The R&D portfolio consists of several late stage research programs in areas ranging from genetic mitochondrial disorders to cancer and metabolic diseases such as NASH. The company’s strategy is to advance drugs for rare diseases through clinical development and into the market. The strategy for projects within larger indications outside the core focus area is out-licensing in the preclinical phase. NeuroVive is listed on Nasdaq Stockholm, Sweden (ticker: NVP). The share is also traded on the OTCQX Best Market in the US (OTC: NEVPF).