Navidea Biopharmaceuticals, Inc. a company specializing in precision immunodiagnostic agents and immunotherapeutics, has disclosed disappointing findings from an exploratory analysis conducted on its pivotal NAV3-33 clinical trial, titled “Evaluation of Tc 99m Tilmanocept Imaging for the Early Prediction of Anti-TNFα Therapy Response in Patients with Moderate to Severe Active Rheumatoid Arthritis (RA)” (ClinicalTrials.gov Identifier: NCT05246280). The exploratory analysis aimed to refine diagnostic performance methodologies for the final pivotal trial.
The results indicate that intravenous Tc 99m tilmanocept effectively targets and generates reliable images of macrophage activity in RA patients. However, these images do not sufficiently predict which patients will respond to anti-TNF alpha therapy.
“We are disappointed that the exploratory analysis did not support the hypothesis of achieving an overall accuracy of early treatment response nearing 90%. Instead, the overall accuracy of early treatment response consistently averaged below 70%,” commented Dr. Michael Blue, Chief Medical Officer of Navidea. “With predictive values at this level, the prospects for a commercially viable product are not promising.”
In light of these outcomes, Navidea has halted all activities associated with the RA Trial. The company now plans to redirect its focus towards exploring opportunities related to its therapeutic assets.
Navidea Biopharmaceuticals, Inc. (OTC: NAVB) specializes in developing precise immunodiagnostic agents and immunotherapeutics. The company is dedicated to advancing multiple targeted products using its Manocept platform, which aims to improve patient care by pinpointing disease sites and pathways. This enhances diagnostic precision, aids clinical decision-making, and facilitates targeted treatments.
Central to Navidea’s approach is the Manocept platform, designed to specifically target the CD206 mannose receptor found on activated macrophages. Tc99m tilmanocept, Navidea’s first product developed and brought to market based on this platform, exemplifies its capabilities.
Navidea’s strategic focus includes driving growth and maximizing shareholder value through the introduction of innovative products. The company aims to expand its pipeline globally through strategic partnerships and effective commercialization efforts.
