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
"Since its founding in 1998, VIRxSYS has achieved remarkable success in an industry riddled with many disappointments"
Dr. Riku Rautsola, VIRxSYS CEO