The Company » Company Milestones

Below are selected milestones and achievements related to VIRxSYS and its programs:

Year
Milestones
2010
 
 
  • In the company's HIV Vaccine monkey study, observed remarkable control of viral load and preservation of the immune system iin some vaccinated animals at the 12 month post-challenge date and beyond.
 
 
  • Presented HIV vaccine monkey study data at various prestigious conferences including: CROI 2010; 2010 Keystone Symposia-HIV Vaccines; XVIII International AIDS Society (IAS) Conference; AIDS Vaccine 2010; and HIV DART 2010.
 
 
  • Held a successful pre-IND meeting with the FDA regarding VRX1273; no major safety or clinical issues were identified.
 
  • Expanded VIRxSYS’ Collaborative Research and Development Agreement (CRADA) with the National Heart Lung and Blood Institute (NHLBI) of the NIH for VRX1243.
 
  • Commenced monkey studies with the NHLBI for VRX1243.
 
  • Invited to present the Company’s SMaRT™ technology at the RNA Therapeutics Meeting in Lisbon, Portugal, co-sponsored by the Harvard Medical School and the EU. 
 
  • Presented VIRxSYS' Lexgenleucel-T (VRX496TM), HIV vaccine (VRX1273) and apoA-I program (VRX1243) at the 13th Annual Meeting of the American Society of Gene and Cell Therapy.
 
  • Selected team of investigators from Harvard and University of California, San Francisco for next Lexgenleucel-T (VRX496™) clinical trial to be conducted with the AIDS Clinical Trials Group (ACTG) of the NIH. Commenced a search for corporate partner to advance Lexgenleucel-T (VRX496™) in collaboration with the ACTG. 
2009
 
 
  • Completed prime/boost vaccinations of non-human primates for VRX1273 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.
 
  • Successfully completed Phase II dose escalation trial for single infusions, multiple infusions, re-infusion groups, further evaluating the safety, tolerability, and therapeutic effect of Lexgenleucel-T (VRX496™).
2008
 
 
  • Initiated non-human primate study for VIRxSYS' 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 VIRxSYS HIV vaccine data at Objectif Recherche Vaccin SIDA (ORVACS).
2007
 
 
  • Performed initial testing of VIRxSYS' HIV vaccine in non-human primates yields encouraging immunogenicity data.
 
  • Acquired the SMaRT™ RNA technology from Intronn, Inc.
 
  • Confirmed in patients the laboratory findings that Lexgenleucel-T (VRX496™) treatment results in non-infectious HIV particles.
2006
 
 
  • Published the Phase I clinical trial results on safety, tolerability and therapeutic effect of Lexgenleucel-T (VRX496™) in the Proceedings of the National Academy of Sciences USA (PNAS).
 
  • Completed multiple infusions of Lexgenleucel-T (VRX496™) in the Phase II clinical trial. Safety and tolerability of multiple doses of Lexgenleucel-T (VRX496™) demonstrated.
 
  • Commenced Phase I/II clinical trial at the University of Pennsylvania to evaluate the safety, tolerability and therapeutic effect of Lexgenleucel-T (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 Lexgenleucel-T (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 Lexgenleucel-T (VRX496™).
 
  • Received a $3.5 million SBIR Phase 2 grant for the development Lexgenleucel-T (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 Lexgenleucel-T (VRX496™) for modified CD4 T cells as an anti-HIV therapy at the University of Pennsylvania. This clinical trial is a first-in-class, first-in-human use of lentiviral vectors 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’ Phase I clinical trial for Lexgenleucel-T (VRX496™).
 
  • Received NIH SBIR Phase 1 grant on integration safety study for Lexgenleucel-T (VRX496™).
 
  • Received $2.7 million NIH grant (to Intronn) for the application of SMaRT™ RNA to cystic fibrosis. The Executive Secretary of the NIH expert review committee stated, “This is one of the most innovative, thoughtful and exciting applications we ever read.”
 
  • Cover story in Nature Biotechnology on use of SMaRT™ in cystic fibrosis.
2001
 
 
  • Completed Pre-clinical studies for Lexgenleucel-T (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 Lexgenleucel-T (VRX496™) to the NIH Recombinant Advisory Committee (RAC) for public review.
 
  • Presented Lexgenleucel-T (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, Lexgenleucel-T (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.

 
 
 

 

 
 

 

 

 

© 2009 VIRxSYS. All rights reserved. Legal Notice
Site powered by True Presence.

"Since its founding in 1998, VIRxSYS has achieved remarkable success in an industry riddled with many disappointments"
Dr. Lawrence Michaelis, VIRxSYS Chairman & CEO