We just got back from presenting data at the 13th American Society of Gene and Cell Therapy (ASGCT) Annual Meeting. It was a great opportunity to connect with the scientific community and share our work vaccine and treatments through RNA therapies. We presented eight abstracts representing results of the company’s clinical trials for Lexgenleucel-T (VRX496™), an autologous cell and gene therapy product for the treatment of HIV/AIDS; preclinical trials of the company’s prophylactic HIV vaccine VRX1023, now called VRX1273; and work utilizing the company’s spliceosome mediated RNA trans-splicing (SMaRT™) platform technology. VIRxSYS has over 40 publications in top tier journals showing the effectiveness of SMaRT™ in a broad variety of applications. Highlights of the presentations include data from VIRxSYS’s Phase 2 study of Lexgenleucel-T, which continue to show no evidence of long-term safety issues after the cumulative infusion of over 4 x 1012 vector copies in a total of 2 x 1012 modified CD4 T cells. To date, data from the Lexgenleucel-T clinical trial program comprises of the largest safety database of subjects enrolled in a clinical trial using a lentiviral vector. In accordance with FDA guidelines, all subjects will continue to be monitored for safety for up to 15 years. Additional data from the Lexgenleucel-T Phase 2 study demonstrate that the therapeutic efficacy of Lexgenleucel-T treatment is not affected by the development of anti-vector antibodies, nor is the development of these antibodies associated with clinically detectable adverse events, a common concern in gene therapy trials. Although our research has not, as of yet, been proven with human trials, our monkey study data is so compelling that it gives us great encouragement and optimism for its potential as an effective HIV Vaccine.
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