A New Clinical Trial for a Novel Brain Injury Biomarker

The challenge with diagnosing chronic traumatic encephalopathy (CTE), a condition that shows up in the overwhelming majority of American football players and other athletes who frequently sustain injuries to the head, is that it can only be diagnosed through an autopsy.

Researchers at Medicortex Finland Oy, are working on a diagnostic kit that could detect CTE in a living person with a simple blood test or other body fluids. Actually being able to diagnose CTE while athletes are alive would mean they could take steps to mitigate the disease before it’s exacerbated with even more hit. The test based on a medical breakthrough biomarker, recently was granted clearance to begin a multi-center clinical trial. The trial will consist of patients that are admitted to emergency rooms due to a head injury.

“Collecting and testing human samples in a clinical trial is a significant accomplishment for Medicortex, and represents a meaningful step forward in the development of a fast-inexpensive diagnostic kit for brain injury detection,” said Dr. Adrian Harel, Chairman and Chief Executive Officer of Medicortex Finland. “Brain injury is a devastating condition with mortality if not diagnosed. The opportunity to develop the first portable non-invasive kit for brain injury and concussion to help the patients and families that so desperately need it is remarkable.”

Samples of body fluids such as blood, urine and plasma will be collected from the study subjects and will be analyzed for a novel biomarker using a biochemical and analytical assay from Medicortex. A special focus will be in catching the patients as soon as possible after the accident and time tracking of the biomarker levels following the injury.

In this clinical trial, Medicortex intends to collect body fluid samples of up to 160 patients who have sustained a head injury, and analyze for the existence of a brain injury biomarker between the patients and healthy control subjects. Based on our earlier laboratory animal tests and the phase one clinical test we can expect positive result from the study.

Dr. Marten Kvist, Medical Director of Medicortex: “We are excited to begin a second clinical study after the promising results of the first trial completed earlier this year. The study is to confirm the clinical relevance of this unique biomarker, and it will lead to development of a diagnostic aid for first responders and paramedics, it will help prioritize evacuation and refrain from administration of contraindicated medications.”

Medicortex Finland Oy is a biotechnology company dedicated to developing diagnostics and treatments for brain injury and concussion. One of the company’s missions is to identify a new biomarker in order to reliably assess the severity and extent of brain injury. Medicortex was founded by Dr. Adrian Harel in Turku, Finland, in 2014 and it operates as a privately owned company. Dr. Harel is a neurobiologist and he has a track record in the business management and leadership of early-stage biotechnology companies.

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