Developer of precision immunodiagnostic agents and immunotherapeutics Navidea Biopharmaceuticals Inc. (NAVB:AMEX), today announced positive results from the company's first interim analysis of its ongoing NAV3-31 Phase 2B study. The company advised in the report that the "Analysis demonstrates that these interim data support Navidea's hypotheses that Tc 99m Tilmanocept imaging can provide robust, quantitative imaging in healthy controls and in patients with active rheumatoid arthritis (RA) and that this imaging is stable, reproducible, and can define joints with and without RA-involved inflammation."
The firm's NAV3-31 Phase 2B trial which included 30 patient subjects is titled "Evaluation of the Precision and Sensitivity of Tilmanocept Uptake Value (TUV) on Tc 99m Tilmanocept Planar Imaging". The study included three arms that included healthy subjects, patients with active, moderate-to-severe rheumatoid arthritis (RA) who are on stable therapy, and a pilot arm of the upcoming Phase 3 trial of Tc 99m tilmanocept as an early indicator of efficacy of anti-TNF alpha treatment in RA patients. The company advised that the whole body and hand/wrist image sets acquired on the same day at multiple time points demonstrated quantitative repeatability and stability of signal, noting that images from patients with active RA show the same localization patterns on images taken a week apart.
The company advised that the data demonstrated quantitative repeatability and stability of signal and it is now continuing to enroll subjects as planned to complete the Phase 2b study and preparing for the upcoming Phase 3 trial.
The company's Chief Medical Officer Michael Rosol commented, "These results support our hypotheses for Arms 1 and 2 of this trial and are key for the path forward to the Phase 3. The demonstration that Tc 99m tilmanocept imaging is stable and has low variability enables us to proceed with confidence in testing our hypothesis that this can be an early indicator of therapeutic efficacy in these patients...With these exciting results in hand, we continue to enroll subjects as planned to complete this Phase 2B and prepare for the upcoming Phase 3."
Navidea's CEO Jed Latkin added, "I am very pleased that the results of this interim analysis are so encouraging. It reaffirms that we are heading in the right direction with our clinical trial pipeline in rheumatoid arthritis. I look forward to continuing this momentum into the Phase 3."
The company explains in the report that "RA is a chronic disease affecting over 1.3 million 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 RA patients worldwide."
Navidea Biopharmaceuticals is based in Dublin, Ohio and has more than 50 employees worldwide. The firm states that it is a "biopharmaceutical company focused on the development of precision immunodiagnostic agents and immunotherapeutics, and 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."
Navidea began the day with a market capitalization of about $14 million with 18.06 million shares outstanding. The stock has a 52-week price range of $0.49-5.32. NAVB shares opened much higher today at $1.24 (+$0.4625, +59.49%) over yesterday's $0.7775 closing price. The stock has traded more than 21 million shares today between $1.09-1.39/share and is currently trading at $1.26 (+$0.4825, +62.06%).
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