The study, being conducted at UCSF Medical Center, is enrolling HIV-1 infected subjects with compromised CD4+ cell counts, to determine whether the procedure will create sufficient HIV-1 resistant CD4+ cells to defer disease progression to AIDS. Enrollment is continuing under a modified protocol designed to increase the proportion of engineered stem cells that engraft in the patient’s bone marrow.
As in its previous study, Enzo’s proprietary StealthVector HGTV43 gene construct is used to transfer into the subjects’ own stem cells antisense genes designed to interfere with HIV-1 growth. These cells should engraft, replicate and differentiate within the body to produce a population of CD4+ T-cells resistant to HIV-1 infection.
Gary Cupit, president of Enzo Therapeutics, said: “The goal in the new study is to produce a renewable supply of engineered CD4+ cells in large enough numbers to allow determining whether these cells can provide for the reconstitution of subjects’ immune systems.”