Immunomedics Inc. has begun European trials of one of itsmonoclonal antibody contrast agents to detect infection, andhas won an orphan product grant to study two more of itsimaging agents to detect malignancies.
The infection imaging agent, ImmuRAID-MN3, expands thecompany's product line beyond the cancer field. As with itsother imaging agents, a monoclonal antibody is linked to acommon contrast agent, technetium-99m, to targetgranulocytes that congregate at infection sites.
Preliminary results with ImmuRAID-MN3 at a German hospitalshowed that the agent can locate infections in the bone orabdomen within one to four hours of injection. The Phase I/IIstudy and a similar study already in progress in the UnitedStates will be followed by a Phase III U.S. trial that thecompany plans to start within a year.
A patent is pending on the technique to label the granulocytemonoclonal with technetium, and a patent has already issuedfor a second generation of labeled, bispecific monoclonals thatrecognize both granulocytes and monocytes, said spokeswomanAmy Factor.
ImmuRAID-AFP and ImmuRAID-HCG, the agents to be studiedunder the orphan product development grant from the Food andDrug Administration, are targeted to detect cancers of themale and female reproductive tracts. The grant, made to theM.D. Anderson Cancer Center in Houston, will fund research fortwo years, Factor said. The amount of the grant was notdisclosed.
Orphan status would give the Warren, N.J., company seven yearsof market exclusively once approval is obtained from the FDA.-- Roberta Friedman, Ph.D.
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