TALLAHASSEE, Fla., May 18, 2018 /PRNewswire/ -- Prevacus, Inc., a leading biopharmaceutical company focused on developing treatments for concussion (mild traumatic brain injury (mTBI)) and other neurological disorders today announced a partnership with BrainScope for use of their FDA-cleared BrainScope One device in Prevacus' upcoming Phase 1b clinical research study as an objective biomarker of brain function. Prevacus and BrainScope are supported in their efforts to find a solution to concussions for youth and professional athletes by 3 Super Bowl MVP quarterbacks including Brett Favre, Kurt Warner and Mark Rypien.
The BrainScope One system to be used in Prevacus' upcoming Phase 1b drug study provides a multi-dimensional assessment of brain function including EEG measures, cognitive performance tests, and standard, digitized concussion assessment tests to aid in standardizing data collection across clinical sites. BrainScope One provides an objective EEG measure, the Brain Function Index, that can be used to assess the functional injury component of the brain after an injury.
"BrainScope One will provide significant assistance during our upcoming phase 1b study," said Dr. Jake VanLandingham, CEO of Prevacus, "We are grateful for their support in pursuit of discovering a solution to concussions for our athletes, military personnel and all other at risk groups."
"We are excited to see BrainScope One's capability being used to provide clinical data points to study Prevacus' new and innovative drugs as an alternate line of therapies for traumatic brain injury," stated Douglas Oberly, Vice President, Clinical Affairs at BrainScope.
Prevacus, Inc. is a biopharmaceutical company developing drug candidates with the potential to advance treatment in the fields of traumatic brain injury and other neurological disorders. The Company's first development candidate (PRV-002) represents a breakthrough strategy for treating concussion working at the molecular level to simultaneously reduce inflammation, swelling, ischemic injury and oxidative stress.
Developed in partnership with the U.S. Department of Defense, FDA-cleared BrainScope One offers a rapid (within minutes) assessment of traumatic brain injury, including concussion, using digital electroencephalography (EEG), along with other modalities, directly on the handheld device to facilitate accurate and timely decision-making for first responders, clinicians, and other health practitioners at the point of care wherever an injury occurs. BrainScope One also offers pharmaceutical researchers objective data they need after initial head injury to confirm inclusion criteria, as well as during the course of the drug candidate administration under clinical investigation. BrainScope has been the recipient of several prestigious awards, including the Frost & Sullivan 2017 Best Practices Award for New Product Innovation in the Traumatic Brain Injury Assessment Solutions Market, as well as a nomination for the Prix Galien Best Medical Technology, regarded as the equivalent of the Nobel Prize for medical devices.
A concussion is a type of traumatic brain injury caused by a significant force to the head or upper body causing the brain to shake inside the skull. The injury is defined as a concussion when it causes a change in mental status such as amnesia, disorientation, mental fogginess, confusion, nausea/vomiting, blurred vision, headache, balance deficits or loss of consciousness. There are 21 symptoms demonstrated to be associated with concussion. Loss of consciousness does not indicate injury severity. Because no two concussions are exactly alike, effects and recovery are sometimes difficult to assess. Therefore, the condition requires a compound that can work to reduce multiple pathological issues.
PRV-002 is a fully synthetic non-naturally occurring neurosteroid administered through the nasal cavity. PRV-002 carries with it equivalent, if not superior, neuroprotective effects compared to related neurosteroids. Animal models of concussion demonstrated that PRV-002 reduces the behavioral pathology associated with brain injury symptoms such as memory impairment, anxiety, and motor/sensory performance. Additionally, PRV-002 is lipophilic and can easily cross the blood-brain barrier to rapidly eliminate swelling, oxidative stress and inflammation in the brain while restoring proper blood flow.
Source: Prevacus, Inc.