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VIRxSYS Presents Update on HIV Gene Therapy Clinical Trial at ICAAC |
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19 Sep 2007 |
Study shows no adverse side effects after more than 65 patient years of treatment
CHICAGO, IL, USA | September 18, 2007 | VIRxSYS Corporation, a privately held company developing genetic therapies for HIV and genetic diseases, announced today the presentation of a new analysis of safety data from Phase I and Phase II studies of VRX496, their proprietary HIV-based lentiviral vector gene delivery system, at the American Society for Microbiology's **47th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Chicago. VIRxSYS has **now accumulated 65 patient-years of data on human administration of VRX496. Five patients in Phase I have been followed for three to four years without serious adverse events. In Phase II, 24 patients have been followed for nine months to one year, and safety monitoring is ongoing.
“The data we are presenting this week furthers our belief that VRX496, our lentiviral vector-based gene delivery system, is safe,” said Riku Rautsola, PhD, President and CEO of VIRxSYS. “We have administered as many as 78 billion transduced cells to patients without any treatment associated adverse events. The results presented here are the first safety data available on the human administration of lentiviral vectors. We are proud that we can share such important news at this prestigious conference.”
Successful results of a Phase I study of VRX496 have previously been reported (Levine et al. PNAS 2006). In ongoing Phase II clinical trials for VRX496, VIRxSYS has treated a total of 24 patients with multiple-doses of VRX496, with half the patients receiving four doses of the therapy, and the other half receiving eight and 16 patients with single bolus infusions ranging from 10 to 30 billion cells per dose. To date, this trial has demonstrated the safety and tolerability of multiple infusions and larger bolus infusions. These patients are currently being monitored to determine the optimal treatment regimen for patients.
About VIRxSYS
Founded in 1998, VIRxSYS is a private biotechnology company that focuses on the development of a novel lentiviral vector platform technology for the treatment of serious diseases such as HIV/AIDS, cardiovascular disease and hemophilia. The Company has exclusively licensed its patented, proprietary technology platform from The Johns Hopkins University (JHU) in Baltimore, Maryland where the original research was conducted. The Company also has been issued additional patents relating to the application and manufacture of the technology. More information regarding VIRxSYS can be found at www.virxsys.com
SOURCE: VIRxSYS |
