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HIV Gene Therapy VRX496 & Vaccine Therapy: VIRxSYS Presents Results from Multiple Studies at the 13th ASGCT Annual Meeting
Prolonged Control of Viremia After Transfer of Autologous CD4 T ... 17th CROI Conference on Retroviruses and Opportunistic Infections ... Expressing Long Antisense to HIV env (VRX496). Reported by Jules Levin CROI 2010 ...
GAITHERSBURG, MD - May XX, 2010 -VIRxSYS Corporation, a privately held company developing vaccines and RNA therapies for serious diseases such as AIDS and cardiovascular disease, will present eight abstracts at the 13th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) taking place in Washington, DC, from May 17-22, 2010. The abstracts represent 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, VRX1273; and work utilizing the company's spliceosome mediated RNA trans-splicing (SMaRT) platform technology.
"We are honored to present so much of our research at the 13th ASGCT Annual Meeting," said Dr. Riku Rautsola, PhD, President and CEO of VIRxSYS. "Our clinical trials continue to demonstrate promising results as we work toward new treatments for HIV. We are also pleased to see our SMaRTTM platform technology performing well in critical pre-clinical studies."
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.
Other highlights include:
· Data from a study evaluating VIRxSYS's lentiviral-based R&D analog HIV vaccine candidate (VRX1273), demonstrating that the vaccine can elicit long-term humoral and cellular HIV-specific immunity and minimal neutralizing activity in immunized mice. These data add to the body of information supporting VRX1273 as a highly attractive HIV vaccine candidate that combines long-term immunogenicity with the ability to elicit weak host neutralizing activity despite repeated immunizations, which was an important factor in terminating other clinical vaccine studies.
· The use of HIV-based lentiviral vectors (LVs) to deliver theSMaRT technology for liver-directed therapies Those LVs express pre-trans-splicing molecules (PTMs) targeting the human albumin RNA transcripts.
The following abstracts will be presented:
Lexgenleucel-T (VRX496)
[Abstract #646] Safety and Efficacy of Autologous CD4+ T cells Transduced with a Lentiviral Vector Delivering Anti-HIV RNA Antisense env in HIV+ Subjects Failing One or More HAART Regimens (Oral Presentation)
[41] Repeated Autologous Infusions of Cells Modified with VSV-G-Pseudotyped Lentiviral Vector VRX496 Can Induce Anti-VSV-G Humoral Response in Humans without Clinical Consequence or Effect on Modified Cells Persistence: Findings from Lexgenleucel-T Phase 2 Clinical Trial (Oral Presentation)
[803] Long Term Persistence of VRX496- Modified CD4+ T Lymphocytes Following Lexgenleucel-T Infusions for the Treatment of HIV/AIDS: Results from a Phase 2 Clinical Trial
[797] Delineation of RNA Antisense env Effects on HIV Quasispecies Recovered from Lexgenleucel-T treated Subjects: Influences of Sequence Similarity of the RNA Antisense with the Targeted HIV env Transcript and VRX496 - Modified Cell Persistence
[800] Inhibition of HIV-1 Replication in VRX496- Modified CD4 T Cells: Importance of Cytoplasmic dsRNA Components
[274] Process Improvements for cGMP Manufacture of Lexgenleucel-T for HIV Treatment
SMaRT Technology
[422] Development of HIV-1 Based Lentiviral Vectors Expressing Pre-Trans-Splicing Molecules (PTMs) for Liver-Directed Therapies
HIV Vaccine
[165] A Lentiviral HIV Vaccine Candidate Elicits Long-Term Humoral and Cellular HIV-Specific Immunity and Minimal Neutralizing Activity
About VIRxSYS' HIV Vaccine Program
VIRxSYS' lentiviral vector vaccine candidate against HIV, VRX1273, is an investigational product in preclinical studies conducted in mice and non-human primates. Based on small animal model studies conducted by VIRxSYS, the vaccine appears to produce stronger anti-HIV immune responses compared to adenoviral vectors similar to those that have been extensively tested in human subjects. This vaccine candidate has also shown encouraging results in the larger animal model, Rhesus Macaques, including induction of long-lasting cellular, humoral responses against SIV antigens and in some animals potent control of SIV infection following in vivo challenge.
About Lexgenleucel-T (VRX496)
Lexgenleucel-T (VRX496) is an investigational RNA-based therapy for the treatment of HIV/AIDS. To date, this autologous cell and gene therapy product has been infused in 65 patients since 2003 which represents an accumulative safety time period of over 210 therapy years. A dose of Lexgenleucel-T is composed of the subject's own CD4 T cells genetically modified ex vivo with VRX496TM, a lentiviral vector derived from HIV-1 itself. Unlike other viral vectors, lentiviral vectors appear to sustain expression of the delivered genes of interest for longer period of time.
About SMaRT Technology
SMaRT is VIRxSYS's proprietary spliceosome-mediated RNA trans-splicing technology for reprogramming and repair of gene expression at the RNA level. This technology has broad therapeutic applications, encompassing siRNA, miRNA and Antigomirs. VIRxSYS has over 40 publications in top tier journals showing the effectiveness of SMaRT in a broad variety of applications.
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