Operational Milestone #1

Clinical grade 1TAX anti-HIV vector was produced for this clinical trial and functions properly. We conducted test runs with the GMP grade vector in patient samples and we achieved a high level of purity of CD34/CD25+ cells (86.7%) and recovered a majority of the cells (79.9%). All release tests were performed on the final product including viability, mycoplasma, sterility, endotoxin, and gram stain and all passed. Also, vector copies per cell of the final product was 2.042 copies/cell.

The immunology team received the first study sample on Aug 19, 2016, and proceeded with sample processing and assays as scheduled.