• Arm 1 consists of healthy subjects.
• Arm 2 is comprised of patients with active, moderate-to-severe RA who are on stable therapy.
• Arm 3 is a pilot arm of the upcoming Phase 3 trial assessing the ability of Tc99m tilmanocept to provide an early indicator of the efficacy of anti-tumor necrosis factor (“TNF”) alpha treatment in RA patients.

This second interim analysis was designed to examine data from Arm 3 of the study in order to evaluate the magnitude of change of Tc99m tilmanocept signal localized to RA-involved joints in patients before and after treatment with an anti-TNF alpha therapy. Also, to examine whether this change in localization, if any, can serve as an early, quantifiable predictor of treatment efficacy.

The Results

Results from the preliminary analysis demonstrate that the interim data are supportive of Navidea’s hypotheses that Tc99m tilmanocept imaging can provide: quantifiable imaging assessment of RA-involved joints that enables early prediction of clinical response as well as longitudinal monitoring of clinical status.

From the CMO at Navidea Pharmaceuticals

Explaining the results, Michael Rosol, Chief Medical Officer for Navidea said that, the interim results, which are in line with the firm’s hypotheses, support the continuation of the current Phase 2B study, and will be fundamental to speaking with the FDA about moving forward into the Phase 3 trial later this year.

Dr. Rosol added “We are excited that we are on track to possibly provide rheumatologists and those suffering from RA a noninvasive, quantifiable, early indicator of whether or not an anti-TNF alpha treatment is working. This could bring enormous benefit to these patients by assisting physicians in putting them on the right course of treatment earlier than would otherwise be possible today.”

Navidea Biopharmaceuticals Manocept™ Platform

Navidea Biopharmaceuticals 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 Tc99m tilmanocept, the first product developed and commercialized by Navidea based on the platform. Navidea’s strategy is to deliver superior growth and shareholder return by bringing to market novel products and advancing the Company’s pipeline through global partnering and commercialization efforts.

For more information please visit the firm’s website at: www.navidea.com.

Prohost Observations

We love the concept and we believe that if the firm successfully passes whatever more testing is required, then it will enable physicians to prescribe the right product for the right person. It could save patients from the torture of products that will not help as well as save the healthcare budget from being spent on the wrong prescriptions.

These advantages are typical outcomes of the practice of personalized medicine.