Takara Bio Inc. announced that Takara Bio and its collaborators, University of Pennsylvania and Drexel University College of Medicine have initiated a Phase 1 clinical trial in its program for HIV-1 infections. Takara Bio has developed an investigational retroviral technology for HIV-1 gene therapy, in which MazF, an endoribonuclease from Escherichia coli, confers resistance to a broad-spectrum of HIV-1 strains on CD4+ T cells. The Regulatory Sponsor of this study is Carl H. June, M.D., Professor of Pathology and Laboratory Medicine at the University of Pennsylvania.

In this clinical trial, the patients will be monitored for safety, tolerability and immunogenicity of the autologous CD4+ T cells modified with the MazF endoribonuclease for six months. The estimated total enrollment is twelve subjects, six in each of the Cohorts 1 and 2.