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Navidea Biopharmaceuticals Initiates Pivotal Phase 3 Registration Program Of NAV5001 SPECT Imaging Agent For Parkinson’s Disease

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced the first subject has been enrolled in one of the two planned NAV5001, pivotal Phase 3 clinical trials. The trial will assess the safety and efficacy of NAV5001, an investigational imaging agent as an aid in the differential diagnosis of Parkinsonian Syndromes from non-Parkinsonian tremor. NAV5001 is an investigational imaging agent used to visualize dopamine transporter protein (DAT) located on the nigrostriatal neurons in the brain using single photon emission tomography (SPECT) imaging. Loss of these neurons is a widely recognized hallmark of Parkinson’s disease and other forms of Parkinsonism.

“Reducing diagnostic uncertainty and error rates for patients with movement disorders who often exhibit similar clinical symptoms would afford great value, especially early in the initial clinical presentation, and may lead to improved clinical decision-making and patient management,” said Ira Goodman, MD, Principle Investigator, Compass Research, LLC, Orlando, FL. “We look forward to evaluating the attributes of NAV5001 as, unlike other agents, its rapid kinetics indicate that we can scan patients very quickly following injection. This is beneficial both for elderly patients and other patients displaying movement symptoms, as well as providing an avenue toward enhanced efficiency, productivity and patient management in the clinic.”

“We are excited to begin this pivotal Phase 3 trial for NAV5001. We believe that NAV5001 has the potential to play an important role in clinical practice where physicians often struggle with the differential diagnosis of movement disorders and tremors such as are present in Parkinson’s disease,” said Cornelia Reininger, MD, PhD, Navidea’s Senior Vice President and Chief Medical Officer. “This registration program will focus on patients with emerging symptoms in whom diagnostic uncertainty and unmet need are highest. Results from earlier trials using NAV5001 suggest that it may be an effective, well-tolerated imaging agent. The high affinity for DAT with resulting clear images can assist physicians in reaching an accurate diagnosis sooner, and the rapid kinetics with minimal time between injection and scanning and time in the SPECT scanner not only decrease patient exposure and but also facilitate increased efficiency with potential cost savings for the nuclear medicine facility.”

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