Tc 99m tilmanocept is the first product developed and commercialized by the company based on the Manocept platform.
The Phase 1 and Phase 2 clinical trials enrolled subjects with active, moderate-to-severe RA and healthy controls.
Images were acquired at various time points post-injection of Tc 99m tilmanocept.
Results from the completed clinical trials show that Tc 99m tilmanocept is well-tolerated with no drug-related adverse events observed.
Additionally, static planar images of joints in active RA subjects demonstrated significant Tc 99m tilmanocept localization to disease-involved joints of the shoulders, knees, hands, and feet.
Whole body and joint-specific static planar imaging in healthy control subjects, as expected, did not reveal joint-specific localization.
RA is a chronic disease affecting over 1.3m Americans and as much as 1% of the worldwide population.
If the product is successfully developed, Navidea would expect to play a major role in the management of worldwide RA patients.
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) is a biopharmaceutical company focused on the development of precision immunodiagnostic agents and immunotherapeutics.
Navidea is developing multiple precision-targeted products based on its Manocept platform to enhance patient care by identifying the sites and pathways of disease and enable better diagnostic accuracy, clinical decision-making, and targeted treatment.
Navidea's Manocept platform is predicated on the ability to specifically target the CD206 mannose receptor expressed on activated macrophages.
The Manocept platform serves as the molecular backbone of Tc 99m tilmanocept, the first product developed and commercialised by Navidea based on the platform.
The development activities of the Manocept immunotherapeutic platform are being conducted by Navidea in conjunction with its subsidiary, Macrophage Therapeutics, Inc.
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