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Takara Bio Initiates Phase 1 HIV Gene Therapy Clinical Trial.

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Tokyo, Jan 8, 2013 - (JCN) - 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. The Principal Investigator of the study is Jeffrey M. Jacobson, M.D., Chief of the Division of Infectious Diseases and HIV Medicine and Professor of Medicine, Microbiology and Immunology Division at Drexel University College of Medicine.

The MazF retroviral vector for this study is manufactured at the GMP compliant Center for Cell and Gene Therapy Facility of Takara Bio (Kusatsu, Shiga, Japan). The patients' CD4+ T cells will be modified with MazF retroviral vector at the GMP compliant Cell and Vaccine Production Facility 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.

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Publication:JCNN News Summaries
Date:Jan 8, 2013
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