Nova Pharmaceutical Corp. said today that it has submitted aninvestigational new drug application to the Food and DrugAdministration to begin Phase I clinical trials of its Septacinimplant to treat chronic osteomyelitis.
Osteomyelitis is a bone infection that affects 200,000 peopleannually in the United States, with about 50 percent requiringsurgical removal of infected bone.
The Septacin implant consists of Nova's Biodel polymer formedinto beads containing gentamicin, an antibiotic. The objectiveof the implant, which is designed to be put in place duringsurgery, is to deliver high concentrations of gentamicin to thedisease site without causing toxic levels in the bloodstream.The polymer is resorbed by the body.
Gentamicin is currently administered intravenously toosteomyelitis patients. But the high intravenous doses cancause kidney damage, vertigo and deafness.
Nova's Gliadel implant, combining a wafer of the polymer withthe cancer drug BCNU, is in Phase III clinical trials.
Stock of the Baltimore company (NASDAQ:NOVX) closed at$4.63, up 63 cents, on Friday.-- Karen Bernstein
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