Company Milestones

VIRxSYS has taken proof-of-concept studies performed at The Johns Hopkins University, completed its Phase I clinical trials in humans, and has initiated Phase II clinical trials in less than seven years. Company milestones are as follows:

Date Milestone
1998 VIRxSYS incorporated
1999 First round of fundraising completed
2000 Initial meeting with the FDA to discuss the VIRxSYS lentiviral vector, VRX496
2001
January 2001 Second round of financing completed
August 2001 Pre-clinical studies completed toward an Investigational New Drug (IND) application
September 2001 VIRxSYS Phase I protocol for VRX496 presented to the NIH Recombinant Advisory Committee (RAC) for public review
October 2001 VRX496 presented to the FDA Biological Response Modifier Advisory Committee (BRMAC) for formal protocol review
2002
April 2002 Third round of financing completed
August 2002 IND application submitted to the FDA for final review of VIRxSYS’s proposed Phase I clinical trial for VRX496
December 2002 VIRxSYS granted permission by the FDA to proceed with the Phase I clinical trial for VRX496 modified CD4 T cells as an anti-HIV therapy; this clinical trial is a first-in-class use of lentiviral vectors in humans for any indication
2003
January 2003 Final approval received from The Institutional Review Board (IRB) at the University of Pennsylvania for Phase I clinical trial to be held at that institution
July 2003 First patient in the Phase I clinical trial dosed with VRX496 modified CD4 T cells
2004
April 2004 VIRxSYS awarded $1.5 million by the NIH for construction of a cell processing center and completion of important safety studies for VRX496 insertion into CD4 T cells
July 2004 Fourth round of financing completed
July 2004 “Fast Track” status granted to VIRxSYS by the FDA for VRX496
September 2004 State-of-the-art cell processing center completed in Gaithersburg, MD
September 2004 Final patient of the Phase I trial dosed
2005
May 2005 All patients in the Phase I trial reached nine-month post infusion, the official end of the trial; participants continue to be monitored
September 2005 Phase II Trial to establish safety and tolerability of multiple infusions of VRX496 commenced
October 2005 Fifth round of financing completed
2006
July 2006 Multiple infusions of VRX496 completed for all patients receiving multiple doses in Phase II trial, demonstrating the safety and tolerability of multiple doses of VRX496
July 2006 Patient from Phase I trial shows safety of treatment and persistence of vector at three years post infusion
September 2006 Phase I/II Clinical trial commenced at the University of Pennsylvania to test the safety, tolerability, and efficacy of VRX496 in HIV-positive patients who are well-controlled by traditional drug regimens
September 2006 Phase I/II clinical trial approved for the  treatment of HIV positive patients who are not on drug therapy, to be conducted at Harvard University, The University of Pennsylvania, and The University of Amsterdam;  AIDS Clinical Trial Group funds received for clinical trial sites in the United States

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