Navidea Biopharmaceuticals Announces Day and Time of SNMMI Presentation of Phase 1/2 Study Results and Enrollment Update on its Phase 2B Study - Seite 2

Michael Rosol, Chief Medical Officer for Navidea, said, “We are excited to present the results from our Phase 1/2 study demonstrating joint-specific localization to inflamed joints of RA subjects when compared to healthy controls, as well as determining the optimum clinical dose for imaging with Tc99m tilmanocept in RA.” Dr. Rosol continued, “These results have provided support to our initiative for the currently running follow-on Phase 2B, as well as our next upcoming Phase 2B and the Phase 3 study intended to garner FDA approval of new indications for Tc99m tilmanocept in RA patients. We are very pleased that enrollment of our first Phase 2B has begun and is proceeding well.”

Bonnie Abbruzzese, Navidea’s Senior Director, Clinical Research, said, “We are pleased that subject recruitment for our Phase 2B has started off at a good pace, and the entire clinical team is working hard to continue to open additional sites as well as to monitor continued subject recruitment. The study results to be presented at SNMMI laid the groundwork for this latest trial, and we are looking forward to seeing the results presented in Anaheim.”

RA is a chronic disease affecting over 1.3 million Americans and as much as 1% of the worldwide population.¹ If the product is successfully developed, Navidea would expect to play a major role in the management of RA patients worldwide.

Reference

1. https://www.rheumatoidarthritis.org/ra/facts-and-statistics/

About Navidea

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 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.