Immunomedics Inc. said Thursday that it has filed a biologics licenseapplication for LeukoScan _ a radiolabeled monoclonal antibodyused to detect bone infections and acute atypical appendicitis.LeukoScan offers a faster, easier method for identifying these seriousinfections.
"We are excited by its prospects because it offers such an attractivealternative for the gold standard currently used to detect infection,"said Paul Herron, director of finance for the Morris Plains, N.J.,company. "The key is that we promised to submit LeukoScan by theend of this year and we are on schedule."
Osteomyelitis _ or bone infection _ affects about 800,000Americans each year and is a major complication of diabetic footulcers in the elderly. Acute appendicitis strikes about 200,000Americans each year. When patients have unusual abdominalsymptoms, doctors can find themselves in the position of decidingwhether to perform surgery without a clear diagnosis of appendicitis.
While bone scans, computed tomography and X-rays can help todiagnose these infections, currently the best method requires thathealth care workers remove and isolate a patient's white blood cells,label them with radioactivity and reinject them into the patient inorder to get an image of the infected area. The procedure can takeanywhere between 24 and 48 hours.
LeukoScan is a monoclonal antibody fragment targeted againstgranulocytes _ white blood cells which congregate at sites ofinfection or inflammation. The antibody is labeled with technetium-99m right before injecting it into the patient's bloodstream and animage pinpointing infection is produced with a standard gammacamera within one to two hours.
The company submitted to the FDA data from clinical trials inapproximately 600 patients from 30 clinical centers. LeukoScan wasable to rule out appendicitis in 97 percent of all cases ofappendicitis. Tests of LeukoScan in detecting osteomyelitis showedthat it accurately diagnosed bone infection 88 percent of the timeand it accurately ruled out the infection 85 percent of the time.
"This product potentially limits health care workers' exposure to HIVand hepatitis B and C because it eliminates blood handling," Herronsaid.
The company has requested that LeukoScan receive a priority reviewfrom the FDA because it protects health care workers from the risk ofblood-borne infections. However, the agency won't make thatdecision until the end of January or beginning of February.
LeukoScan recently received a recommendation for approval fromthe European Committee for Proprietary Medicinal Products. Herronsaid the company expects to lead to marketing approval in all 15countries of the European Union.
The company is currently seeking a partner to market LeukoScanshould the FDA approve the product. n
-- Lisa Seachrist Washington Editor
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