Navidea (NYSE:NAVB) said today it is beginning the clinical trial development process as it seeks an indication for its Lymphoseek injection for treating rheumatoid arthritis and other disease states.
The decision came after a recent meeting with the FDA, the Dublin, Ohio-based company said.
“Our efforts to continue to unlock the significant value of the Manocept platform are well underway as we seek to expand Lymphoseek’s label so it can be used as an immunodiagnostic for additional diseases. This collaborative meeting with FDA has enabled us to continue to advance the regulatory process and begin to implement our clinical program in rheumatoid arthritis, an indication that has an addressable market that is substantially larger than the current Lymphoseek indications. We look forward to reporting our progress throughout the year,” CEO Rick Gonzalez said in prepared remarks.
The company said it conducted a series of meetings with the FDA as it seeks to extend the indications for Lymphoseek to include IV administration, and said it has initiated clinical development for the process.
Navidea said it submitted summary results in a briefing package to the FDA, as well as landing NIH grants in RA and Kaposi’s Sarcoma worth up to $3.8 million to support Phase 2 studies.
Based on its meetings, the company said it expects to submit an IND amendment to allow for Phase 1/2 IV studies of Lymphoseek, which will allow it to develop Lymphoseek in “broader immunodiagnostic disease application,” including rheumatoid arthritis.
The company expects to initiate the studies during the 2nd half of 2016, with a Phase 1 pilot examining subcuatneous injection in RA subjects in the 2nd quarter of 2016.
