Navidea Biopharmaceuticals completes NAV4694 clinical trial

Navidea Biopharmaceuticals has completed a clinical trial to investigate the Radiopharmaceutical agent NAV 4694.

The solution could be used as a biomarker for visual detection and quantification of cerebral B-amyloid in diagnosing Alzheimer's disease (AD), with the study including prep work to assess the effects that mass amounts of the drug could have on the safety and efficacy of Positron Emission Tomography.

Evaluations were carried out on the effects of two mass doses of the radiogland on binding parameters and overall image quality.

These endpoints are typical and important requirements of drug registration dossiers that are filed with regulatory authorities for the approval of diagnostic agents.

In the trial, 16 individuals participated, with eight suffering from mild to moderate AD, and eight elderly HVs were imaged on two PET systems at Karolinska Institutet premises in Stockholm, Sweden.

Elderly HVs took part in the study to show that no unexpected tracer mass effects of AZD4694 in people with low or cerebral b-amyloid occur to compare imaging parameters from healthy, non-AD subjects with those with AD.

"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," Cornelia Reininger, Navidea's chief medical officer, said.

The representative went on to say that NAV4694 exhibits the strengths of C PIB, the benchmark amyloid imaging agent, but is radio-labelled with F, which has attributes that make it more practical to use.

As well as this, the expert indicated that the research indicates NAV694 shows favourable sensitivity, specificity, rapid brain uptake along with decreased white-matter uptake, leading to improved image clarity.

"We remain very enthusiastic about the potential of NAV4694 to advance clinical capabilities in diagnostic and therapeutic development for Alzheimer’s disease," Dr Reninger explained.