Sheffield Medical Technologies Inc. has filed an investigational newdrug application with the FDA to begin Phase I/II clinical trials of itsCD4 electroinsertion technology, RBC-CD4, for HIV.The Houston-based company said the study will involve 18 HIVinfected patients and will be conducted at the Johns Hopkins UniversityMedical Center in Baltimore. The trial will test for safety at variousdosage levels and efficacy.The RBC-CD4 electroinsertion technology, according to Sheffield, isdesigned to alter red blood cells to make them appear as T cells, thechief target of HIV. The RBC-CD4 cells are supposed to act as decoys,attracting HIV and freeing up real T cells to strengthen the immunesystem. In addition, the company's researchers said the HIV that bindsto the altered cells eventually would become inactive because the RBC-CD4 cells don't have nuclei to replicate. And the researchers said HIV-infected cells would be neutralized as RBC-CD4 cells interact withgp120, a glycoprotein present on the surface of infected cells.Phase I studies of the drug, the company said, showed no side effectsor immune response in those infused with RBC-CD4. _ Charles Craig
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