Immunomedics Inc.'s imaging agent LeukoScancompared favorably to conventional infectious-diseasediagnostics in a phase III study, investigators reportedTuesday.
LeukoScan was tested for its ability to imageosteomyelitis in long bones and in patients with diabeticfoot ulcers. Results showed the agent was comparable orbetter than procedures using radiolabeled white bloodcells to image infectious disease.
That data, combined with the comparative benefits ofLeukoScan _ ease of use, reduced waiting time andelimination of blood handling _ will help form thepackage when Immunomedics submits for marketingapproval.
Immunomedics Chairman David Goldenberg saidregulatory filing for LeukoScan would be made in thefourth quarter or later. Meanwhile, the Morris Plains,N.J., company has a meeting with an FDA advisory panelnext month concerning its colorectal cancer imagingagent, CEA-Scan.
LeukoScan is a murine monoclonal antibody fragment,labeled with technetium-99, specific for the NCA-90antigen on the surface of granulocytes at the site ofinfection or inflammation. A patient can be imaged,sometimes within an hour after administration, with agamma camera. It also is in Phase III studies for infectedprosthesis and appendicitis indications, and underregulatory review in Europe.
In the trial data reported Tuesday, LeukoScan wascompared to indium-111 white blood cell imaging, whichtakes longer and involves removal and re-injection ofblood.
LeukoScan provided benefit in terms of sensitivity (88percent), specificity (66 percent) and accuracy (77percent), according to the presentation at the InterscienceConference on Antimicrobial Agents and Chemotherapyin San Francisco. The comparative portion of the studyshowed LeukoScan to statistically more sensitive (p =0.003) and about the same in the other areas. n
-- Jim Shrine
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