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
2009
Successfully completed Phase II dose escalation trial for single infusions, multiple infusions, re-infusion groups, further evaluating the safety, tolerability, and therapeutic effect of VRX496™
Completed prime/boost vaccinations of non-human primates for VRX1023 HIV vaccine candidate. Immunogenicity data continues to be very encouraging.
Implemented large scale lentiviral vector production using proprietary stable cell line technology.
Awarded grant from the State of Maryland Stem Cell Research Fund for the advancement of iPS (induced pluripotent stem cells) using VIRxSYS' SMaRT™ RNA technology and lentiviral vector platforms.
Performed proof of principal of integrating VIRxSYS' lentiviral platform with SMaRT™ RNA platform.
2008
Initiated non-human primate study for VRX1023 anti-HIV vaccine candidate.
Presented VIRxSYS HIV vaccine data at 125th anniversary of the founding of the Pasteur Institute.
Received invitation to be a discussant at the 25th commemorative meeting of the discovery of HIV/AIDS.
Received special invitation to present VRX1023 HIV vaccine data at Objectif Recherche Vaccin SIDA (ORVACS).
2007
Confirmed in patients the laboratory findings that VRX496™ treatment results in non-infectious HIV particles.
Performed initial testing of VRX1023 vaccine in non-human primates yields encouraging immunogenicity data.
Acquired the SMaRT™ RNA technology from Intronn, Inc.
2006
Published the Phase I clinical trial results on safety, tolerability and therapeutic effect of VRX496™ in the Proceedings of the National Academy of Sciences USA (PNAS).
Completed multiple infusions of VRX496™ in the Phase II clinical trial. Safety and tolerability of multiple doses of VRX496™ demonstrated.
Commenced Phase I/II clinical trial at the University of Pennsylvania to evaluate the safety, tolerability and therapeutic effect of VRX496™ in HIV-positive patients who are well-controlled (patients on anti-retroviral HIV therapy who have fully suppressed HIV viral loads).
2005
Completed state-of-the-art cell processing center in Gaithersburg, Maryland.
Commenced Phase II Multiple Infusion Trial to evaluate the safety, tolerability and therapeutic effect of multiple infusions of VRX496™.
Executed Cooperative Research and Development Agreement (CRADA) with National Heart, Lung and Blood Institute of NIH for the cardiovascular applications of SMaRT™.
2004
Received "Fast Track" status by the FDA for VRX496™.
Received a $3.5 million grant for the development VRX496™ cell processing.
Demonstrated proof of principal of genomic applications for SMaRT™ RNA trans-splicing. Work funded by a grant from National Human Genome Research Institute of NIH.
2003
Commenced the Phase I clinical trial for VRX496™ for modified CD4 T cells as an anti-HIV therapy at the University of Pennsylvania. This clinical trial is a first-in-class use of lentiviral vectors in humans for any indication.
Received $3.5 million grant from NIH for the application of SMaRT™ RNA technology for hemophilia A.
Developed high throughput screen for SMaRT™.
2002
Submitted IND application to the FDA for VIRxSYS’s Phase I clinical trial for VRX496™.
Received NIH grant on integration safety study for VRX496™.
Received $2.7 million NIH grant for the application of SMaRT™ RNA to cystic fibrosis. The Executive Secretary of the NIH review committee of experts stated, “This is one of the most innovative, thoughtful, and exciting applications they ever read.”
Cover story in Nature Biotechnology on use of SMaRT™ in cystic fibrosis.
2001
Completed Pre-clinical studies for VRX496™ toward an Investigational New Drug (IND) application.
Completed first-in-kind cGMP facility for manufacturing clinical grade lentiviral vector in Gaithersburg, Maryland.
Presented Phase I protocol for VRX496™ to the NIH Recombinant Advisory Committee (RAC) for public review.
Presented VRX496™ to the FDA Biological Response Modifier Advisory Committee (BRMAC) for formal protocol review.
Executed Cooperative Research and Development Agreement (CRADA) with National Cancer Institute for molecular mechanisms of SMaRT™.
2000
Held initial meeting with the FDA to discuss the VIRxSYS’ first product, VRX496™ anti-HIV gene therapy.
Received first US patents for SMaRT™ RNA trans-splicing technology.
1999
Established research and development facilities in Gaithersburg, Maryland.
1998
Incorporated VIRxSYS.
Licensed foundational lentiviral technology from The Johns Hopkins University.
"Since its founding in 1998, VIRxSYS has achieved remarkable success in an industry riddled with many disappointments"
Dr. Riku Rautsola, VIRxSYS CEO