Navidea Biopharmaceuticals to Begin Trial for RA Drug

Navidea Biopharmaceuticals, Inc. has the green light from the FDA to begin the clinical trial development process for its intravenous (IV) injection protocols for use of Lymphoseek injection in rheumatoid arthritis (RA) and other diseases. Lymphoseek is Navidea’s first commercial product from its Manocept platform.

“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, ” said Navidea President and CEO Rick Gonzalez in the April 4, 2016 news release. “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.”

As indicated in the news release, “Navidea’s efforts to exploit the involvement of macrophages in the natural history of many diseases, has led us to our strategy of expanding the Lymphoseek label and opening new market opportunities. Lymphoseek’s active ingredient, tilmanocept, is highly specific and selective for a receptor found on the surface of macrophages. This targeted mechanism of action has opened the potential for Lymphoseek (tilmanocept) as an immunodiagnostic in broad inflammatory disease areas such as rheumatoid arthritis (RA), Kaposi’s sarcoma, and cardiovascular disease, among others.”

Navidea Corporate Communications and CEO Rick Gonzalez told OTW, “Our primary market research identified two distinct clinical aspects in RA that are significant unmet medical needs in RA: 1) early diagnosis and 2) monitoring of disease progression and/or drug response. Early diagnosis and treatment remarkably improves outcomes, especially long-term prognosis. Rheumatoid arthritis joint damage occurs early, typically within the first two years of the disease and is irreversible. Additionally, once treatment is started, it becomes necessary to objectively monitor progression and measure response to treatment.”

“Approximately 10 million patients in economically advantaged countries alone are diagnosed with RA, of which approximately half are misdiagnosed due in large part to a lack of an accurate and cost-effective means for early detection and differential diagnosis. This is an indication that has an addressable market that is substantially larger than the current Lymphoseek indications in oncology.”

“The label expansion requires an IND [investigational new drug] amendment to the existing Lymposeek IND/label for an intravenous (IV) route of administration for Lymphoseek prior to proceeding in the clinic in RA. As noted, following our recent meeting with the FDA, we are submitting the amendment. The current development plan is to:

• Initiate Phase 1 trial evaluating subcutaneous injection of Lymphoseek in active RA subjects in second quarter 2016;
• Initiate additional multi-center Phase 1/2 registrational trials in RA employing IV-administration in the second half of 2016.”

“Successful outcomes would allow us to initiate Phase 3 studies for the “detection of RA” label as early as next year with the goal of being on the market as early as 2019.”