Navidea Biopharmaceuticals Announces Completion Of Additional Fundamental Clinical Trial For Radiopharmaceutical Agent, NAV4694, In Alzheimer’s Disease

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced the completion of a study of its novel radiopharmaceutical NAV4694 as a biomarker for visual detection and quantification of cerebral β-amyloid in diagnosing Alzheimer’s disease (AD). The study was designed and conducted by Navidea’s partner, AstraZeneca, to assess the effects of various mass amounts of AZD4694 (NAV4694) on safety and the efficacy of Positron Emission Tomography (PET) scanning in subjects with AD and in healthy volunteers (HVs). Evaluations were completed on the effects of two mass doses of the radioligand on binding parameters and overall image quality. These endpoints are typical and important requirements of drug registration dossiers filed with regulatory authorities for approval of diagnostic agents.

The completed trial was an open-label, non-randomized, multi-center, PET study in a total of sixteen individuals (8 with mild to moderate AD and 8 elderly HVs) each imaged on two PET systems at Karolinska Institutet sites in Stockholm, Sweden. The study included elderly HVs to demonstrate that no unexpected tracer mass effects of AZD4694 (NAV4694) in subjects with low or no cerebral β-amyloid occur; to compare imaging parameters from healthy, non-AD subjects with those from subjects with AD; and to extend the safety database.

“We are very pleased to have completed this study addressing some of the fundamental requirements of diagnostic imaging agents seeking approval. We continue to make exciting progress with NAV4694, which has demonstrated important performance characteristics that we believe position it as a true ‘best-in-class’ second generation agent to aid in the diagnosis of Alzheimer’s disease,” said Cornelia Reininger, MD, PhD, Navidea’s Chief Medical Officer. “As previously reported in other Phase 2 studies, NAV4694 exhibits the strengths of ¹¹C PIB, the benchmark amyloid imaging agent, but, as the agent is radio-labeled with ¹⁸F, has distribution characteristics that make it more practical to use. The data from these studies suggest that NAV4694 shows favorable sensitivity, specificity, rapid brain uptake yet decreased white-matter uptake which affords improved image clarity.”

Dr. Reininger added, “We remain very enthusiastic about the potential of NAV4694 to advance clinical capabilities in diagnostic and therapeutic development for Alzheimer’s disease. Results from this study are expected to be reported at the 2013 Annual Meeting of the Society of Nuclear Medicine and Molecular Imaging. We look forward to initiation of the NAV4694 Phase 3 study in 2013.”

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