01 Aug New Biomarker Has Potential For Sideline Diagnosis of Traumatic Brain Injury
MedicalResearch.com Interview with:
Dr. Adrian Harel, PhD
Chief Executive Officer
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Every 15 seconds, someone in the United States suffers a new head injury. Of the 2.5M people treated in hospital emergency rooms each year, 80,000 become permanently disabled because of TBI. Currently, there are no reliable diagnostic tests to assess the presence or severity of an injury on-site, nor are there any pharmaceutical therapies that could stop the secondary injury from spreading. Accurate diagnostics would benefit especially mild cases of TBI (concussions), which, if occurring repeatedly, may cause neurodegenerative conditions such as Chronic Traumatic Encephalopathy (which is typical for athletes in NFL and Ice-hockey).
We have performed extensive preclinical research comparing fluid biopsies from normal and injured lab animals. The results showed some unique biomarkers released as a biodegradation products after head injury. The data served as the basis and confirmation for our patent applications to protect the biomarker concept.
Medicortex has completed a clinical proof-of-concept trial in collaboration with Turku University Hospital (Tyks). Samples from 12 TBI patients and 12 healthy volunteers were collected and analyzed for the presence and for the level of the biomarker in state-of-the-art laboratories. The study demonstrated the diagnostic potential of the new biomarker in humans and it confirmed the prior preclinical findings. This was a significant milestone for Medicortex.
MedicalResearch.com: What should clinicians and patients take away from your report?
Response: A new biomarker can be found in noninvasive samples of body fluids (Urine, saliva), a fast and non-expensive kit can we developed if sufficient finance is available. The TBI detection kit can be used by side-line trainers, paramedics and first responders. If the health of NFL players, Ice-hockey players, army personal, etc. are important, investment in the development of such a detection kit is a must!
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: Medicortex Finland is dedicated to improving the diagnostics and treatment of Traumatic Brain Injury (TBI). Our current focus is on the development of biomarker diagnostics to evaluate the extent and severity of traumatic brain injury and concussion. Once the development of the diagnostic kit is complete, the next goal is to expand our program to the development of an innovative drug to halt the progression of brain injury.
SECOND CLINICAL TRIAL Medicortex is planning to start in Q4/2017 a larger clinical cohort study comprising more than 120 patients in collaboration with two Finnish hospitals. The existence and diagnostic indication of the biomarker in various situation as well as it’s chemical composition will be evaluated more comprehensively than in the preceding study. The main objective will be to identify false positive/false negative cases.
Disclosures: Medicortex holds 2 patent applications giving it a strong intellectual position. The biomarker can be further used as an end-point in clinical studies, as a prognostic tool in hospitals and by insurance companies.
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Mez J, Daneshvar DH, Kiernan PT, Abdolmohammadi B, Alvarez VE, Huber BR, Alosco ML, Solomon TM, Nowinski CJ, McHale L, Cormier KA, Kubilus CA, Martin BM, Murphy L, Baugh CM, Montenigro PH, Chaisson CE, Tripodis Y, Kowall NW, Weuve J, McClean MD, Cantu RC, Goldstein LE, Katz DI, Stern RA, Stein TD, McKee AC. Clinicopathological Evaluation of Chronic Traumatic Encephalopathy in Players of American Football. JAMA. 2017;318(4):360-370. doi:10.1001/jama.2017.8334
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