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Navidea gains IRB approval for technetium Tc 99m tilmanocept clinical trial
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Navidea Biopharmaceuticals Inc. recently announced its clinical trial protocol for a technetium Tc 99m tilmanocept injection was approved by the Institutional Review Board from the University of California, San Francisco School of Medicine, according to a press release.
The technetium Tc 99m tilmanocept (Lymphoseek) injection is a Manocept platform product and reportedly is the only FDA-approved receptor-targeted lymphatic mapping agent. The clinical trial will evaluate the product’s efficiency in identifying active rheumatoid arthritis (RA) in joints previously known to be affected by RA.
“This IRB approval is an important and significant advancement in the expansion of the Manocept platform as we can now start enrollment in this seminal RA immunodiagnostic study,” Frederick O. Cope, PhD, chief scientific officer of Navidea, said in the press release. “We believe in the medical value of Manocept platform to enhance the specific diagnosis of inflammatory and infectious diseases to benefit patient care and guide treatment.”
Frederick O. Cope
Up to 18 participants will be enrolled in the open-label, phase 1 study. Both patients with active RA and no known arthritis will be included in the clinical trial. The participants will be categorized into four cohorts to examine the ability of two different doses of the product in each group to pinpoint RA-affected joints in patients with active RA. Study results will be based upon SPECT and SPECT/CT imaging.