Banyan Biomarkers Initiates International Traumatic Brain Injury Clinical Trial to Evaluate Biomarkers
Posted on: Tuesday, 6 November 2007, 12:00 CST
Banyan Biomarkers, Inc. today announced initiation of a multi-center, international clinical trial designed to prove the effectiveness of the Company's proprietary protein biomarkers in detecting traumatic brain injury. Banyan Biomarkers has developed a panel of biomarkers that will be tested in blood and cerebrospinal fluid samples from over 200 severe traumatic brain injured patients. If positive, the results will be submitted to the FDA as a feasibility study in preparation for a subsequent pivotal trial. Ultimately, Banyan Biomarkers' goal is to receive FDA approval for the Company's biomarkers to be used as in vitro diagnostic blood tests for detecting brain injury. Banyan Biomarkers' clinical study is the first effort to systematically evaluate biomarker utility in brain-injured patients. Banyan has pre-clinical data from animal models indicating that the Company's biomarkers could be useful diagnostic indicators for brain injury.
The multi-center study, funded by the U.S. Department of Defense, will be conducted at the following locations: R. Adams Cowley Shock Trauma Center at the University of Maryland Medical Center; Orlando Regional Medical Center, Orlando, Florida; University of California Davis Health System, Sacramento, California; University Pecs and University of Szeged, Hungary; and the University of Padova, Italy.
Cerebrospinal fluid and blood from patients experiencing severe traumatic brain injury will be collected at 6 hour intervals over 10 days. In addition to Banyan Biomarkers analyzing the biomarker levels in these samples, extensive clinical data will be collected on each patient including computed tomography (CT) images and patient outcome along with changes in patient blood pressure and intracranial pressure. This effort will allow rigorous assessments of changes in biomarker levels and patients' clinical status and, ultimately, provide an unprecedented data collection base and clinical sample bank.
With financial support from the U.S. Department of Defense, Congress and the National Institutes of Health, Banyan Biomarkers, Inc. has identified the proteins, or biomarkers, that are released from the brain and make their way into the bloodstream after brain injury. Initial funding from the Department of Defense is allowing Banyan Biomarkers to also evaluate the effectiveness of their proprietary biomarkers in detecting mild and moderate head injury. These studies will begin in 2008.
Source: Business Wire
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