Navidea, Molecular Neuroimaging Begin Trial of Dementia SPECT Imaging Agent

April 5, 2013 — Navidea Biopharmaceuticals Inc. announced that collaborators at Molecular Neuroimaging LLC (MNI) in New Haven, Conn., have enrolled the first subject in a clinical study to investigate the performance of [123I] NAV5001 in a single photon emission computed tomography (SPECT) imaging procedure in connection with Navidea’s program to evaluate NAV5001 in Dementia with Lewy Bodies (DLB).

"This collaborative investigator-initiated study is an important first step in recommencing a full clinical development program for NAV5001 since our in-licensing this candidate in late 2012,” said Mark Pykett, Navidea’s president and CEO. “Collaborations such as this are integral to Navidea's strategy to efficiently and effectively advance the development of our promising radiopharmaceutical pipeline and representative of our focus of being a leader in the field of precision diagnostics.”

“The study is the first leg of our program to evaluate the utility of NAV5001 in DLB, the leading form of dementia after Alzheimer’s disease and an important potential indication for NAV5001 medically and commercially,” commented Cornelia Reininger, M.D., Ph.D., Navidea’s senior vice president and chief medical officer. “During 2013, we look forward to following this study with the initiation of a company-sponsored Phase 2b study of NAV5001 in DLB as well as the anticipated start of the Company’s pivotal parallel Phase 3 registration studies of NAV5001 as an aid in the differential diagnosis of Parkinsonian syndromes."

The goal of this single center, open-label, investigator-initiated study will be to assess the distribution, safety and tolerability of NAV5001 as an agent to evaluate the integrity of the dopamine transporters in the brain, using healthy volunteers. NAV5001 is an investigational radiopharmaceutical imaging agent being developed as an aid in the differential diagnosis of Parkinsonian syndromes, including Parkinson’s disease (PD) and other movement disorders, as well as Dementia with Lewy Bodies (DLB). Danna Jennings, M.D., clinical research director at MNI will lead the investigator-initiated clinical study.

For more information: www.navidea.com