SARASOTA, Fla. - Oragenics (NYSE:OGEN), Inc. (NYSE American: OGEN), a biopharmaceutical company, today announced the appointment of neurologist Dr. James "Jim" Kelly as Chief Medical Officer (CMO). Dr. Kelly will oversee the Phase II clinical trial of ONP-002, the company's lead drug candidate for the treatment of mild Traumatic Brain Injury (TBI), commonly known as concussion.
Dr. Kelly, a recognized expert in the field of neurology, brings extensive experience to Oragenics, having previously served as Executive Director of the Marcus Institute for Brain Health and Professor of Neurology at the University of Colorado Anschutz Medical Campus. His background includes leading the National Intrepid Center of Excellence and involvement with the FDA and clinical trials for brain injury.
The company's President, Michael Redmond, expressed confidence in Dr. Kelly's leadership, emphasizing his expertise in concussion and other brain injuries. Oragenics is currently finalizing the drug's manufacturing and formulation to ensure its integrity for the upcoming trials.
ONP-002 is designed to be administered intranasally, targeting the brain directly through the nasal cavity. A completed 40-patient Phase I study indicated that the drug is safe and well-tolerated. The upcoming Phase II study aims to establish the timing for the first dose, the relationship between drug application and blood biomarkers, and the evaluation of clinical endpoints to determine patient outcomes.
Concussions represent a significant global health concern, with an estimated 69 million cases reported annually. They are often caused by falls, motor vehicle accidents, and contact sports, and can lead to long-term disabilities such as post-concussion syndrome, which affects up to 20% of those injured.
Oragenics' press release statement indicates that the company is moving forward with the Phase II trial, aiming to address the unmet medical need for effective concussion treatment. The company cautions that forward-looking statements involve risks and uncertainties and that actual results may differ materially from those projected.
This news is based on a press release statement from Oragenics, Inc. and does not constitute an endorsement of the company or its products.
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