Immunomedics Inc.'s monoclonal antibody-based imagingagent ImmuRAID-MN3 was 93 percent accurate in identifyinginfections in a Phase II trial involving 39 patients.
Jay Winship, Immunomedics' director of clinical research,presented the study results on Tuesday at the InterscienceConference on Antimicrobial Agents and Chemotherapy(ICAAC) in New Orleans. "The imaging sensitivity for MN3 was93 percent, specificity 85 percent, and positive predictive valuewas 90 percent," Winship said. He added that human anti-mouse antibody titers were negative one month and/or threemonths post-injection in 24 patients tested to date; no adversereactions were observed.
"These preliminary results suggest that Tc-99m labeled Mn3scanning compares favorably with white blood-cell scanningand may be safer," Winship said.
ImmuRAID-MN3 consists of an anti-granulocyte antibodyfragment labeled with the radioisotope technetium-99m (Tc-99m), which when injected into the body, seeks out andattaches to granulocytes, a type of white blood cell produced bybone marrow to fight infections. A nuclear medicine cameralocates the radioisotope concentrations in the body thatidentify the extent of infection.
Immunomedics (NASDAQ:IMMU) of Morris Plains, N.J.,explained that unlike indium-111- and Tc-99m-labeledleukocyte imaging techniques, which are routinely used tolocalize points of infection, its labeled antibody fragment doesnot require blood handling and in vitro labeling of white cells.MN3 is administered by direct intravenous injection,eliminating the need for cell isolation.
MN3 is in Phase III testing for locating and determining theextent of suspected infections affecting prosthetic joints,osteomyelitis in diabetic foot ulcers and long boneosteomyelitis. Immunomedics said it plans to file a productlicense application (PLA) with FDA and other worldwideregulatory agencies next year. A PLA for the company's firstimaging agent, ImmunoRAID-CEA for colorectal cancer, iscurrently pending at FDA and regulatory agencies in Europeand Canada.
-- Brenda Sandburg News Editor
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