October 17, 2008
Preliminary Phase I Safety Data for Preventive HIV Vaccine Delivered By Ichor’s TriGrid to Be Presented at AIDS Conference
Ichor Medical Systems, whose advanced TriGrid(TM) Delivery System is being tested worldwide for its ability to enhance delivery of DNA drugs and vaccines, announced today that preliminary safety and tolerability data for a Phase I preventive HIV vaccine clinical trial being conducted at the Rockefeller University Hospital in New York City will be presented at the AIDS Vaccine Conference in Cape Town South Africa this week. Recruitment of trial participants, comprised of healthy HIV-negative volunteers, is now complete.
The trial is testing the ability of the TriGrid(TM) to enhance delivery of the ADVAX DNA-based HIV vaccine developed by the Aaron Diamond AIDS Research Center (ADARC) and the International AIDS Vaccine Initiative (IAVI). The TriGrid(TM) uses a process called electroporation to open pathways into cells, facilitating entry of DNA into the cells with the goal of increasing the ability of DNA vaccines to stimulate immune responses. DNA vaccines may be well suited to provide protective immunity to HIV without concerns regarding pre-existing immunity to the vector, as is the case with some viral vectors. Efficiently delivering DNA vaccines into cells has been a major challenge thus far, but Ichor's TriGrid(TM) may be a solution. This study represents the first clinical trial of electroporation-mediated DNA vaccine delivery in healthy human volunteers. The trial is part of the Collaboration for AIDS Vaccine Discovery (CAVD) and is funded by a grant to ADARC from the Bill & Melinda Gates Foundation.The primary goal of the ADARC/IAVI/Ichor/CAVD study is to evaluate the safety and tolerability of delivering ADVAX to healthy subjects using Ichor's TriGrid(TM) delivery device, while immunogenicity of the vaccine will be evaluated as a secondary objective. The findings of the clinical trial to date, which will be presented in Cape Town, indicate that the TriGrid(TM)-mediated delivery of the vaccine appears to be safe, well-tolerated and acceptable to healthy human volunteers. Analyses of immune responses are currently underway at ADARC and IAVI.
"We are grateful to all of the participants in this trial and remain hopeful that this study will provide important information relevant to the long term goal of developing a vaccine for HIV," said Bob Bernard, CEO of Ichor. "We look forward to continuing this study with ADARC, IAVI and CAVD and are fortunate to be working with such a prestigious team headed by Dr. David Ho, CEO of ADARC and Irene Diamond Professor at the Rockefeller University."
In addition to this human study, findings from a promising study in mice with a DNA vaccine for Avian Flu developed by researchers at ADARC and Academia Sinica in Taiwan, delivered with the TriGrid(TM) were recently published in the Proceedings of the National Academy of Sciences. The groups hope to advance this candidate into human trials in the near future.
About Ichor Medical Systems
Ichor Medical Systems' TriGrid(TM) Delivery System is the first integrated and fully automated system for electroporation-mediated DNA administration in humans. Ichor, a privately-held biotech company based in San Diego, CA, is collaborating with partners on three continents in a wide range of studies to test the TriGrid as an enabling platform for delivery of DNA drugs and vaccines to treat diseases such as pandemic flu, hepatitis B, HIV, melanoma, multiple sclerosis, and others. The TriGrid is also being tested by the U.S. military as an efficient means of delivering biodefense countermeasures.
Ichor's current research partners also include Bayhill Therapeutics, Delphi Genetics, FIT Biotech, Genexine, INSERM, the Johns Hopkins Bloomberg School of Public Health, Leiden University Medical Center, Memorial Sloan-Kettering Cancer Center, the Pasteur Institute, Pharmexa-Epimmune, ScanCell, The Scripps Research Institute, the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), the Naval Medical Research Center (NMRC), the University of Georgia, University of Constance and the Vaccine and Infectious Disease Organization (VIDO). For further information, visit www.ichorms.com.
About Aaron Diamond AIDS Research Center (ADARC)
The Aaron Diamond AIDS Research Center is a large non-profit HIV/AIDS research center in New York City, affiliated with the Rockefeller University. Founded in 1991, ADARC focuses both on basic research efforts to increase understanding of the structure and function of HIV and to define the mechanism by which it destroys the immune system, and on translational efforts to develop novel therapies to treat and prevent HIV. In recent years, development of novel vaccines to prevent HIV infection has been a substantial focus of research at ADARC.
The International AIDS Vaccine Initiative (IAVI) is a global not-for-profit organization whose mission is to ensure the development of safe, effective, accessible, preventive HIV vaccines for use throughout the world. Founded in 1996 and operational in 24 countries, IAVI and its network of collaborators research and develop vaccine candidates. IAVI's financial and in-kind supporters include the Alfred P. Sloan Foundation, the Bill & Melinda Gates Foundation, the Foundation for the National Institutes of Health, The John D. Evans Foundation, The New York Community Trust, the James B. Pendleton Charitable Trust, The Rockefeller Foundation, The Starr Foundation, The William and Flora Hewlett Foundation; the Governments of Canada, Denmark, India, Ireland, The Netherlands, Norway, Spain, Sweden, the United Kingdom, and the United States, the Basque Autonomous Government as well as the European Union; multilateral organizations such as The World Bank; corporate donors including BD (Becton, Dickinson & Co.), Bristol-Myers Squibb, Continental Airlines, Google Inc., Henry Schein, Inc., Merck & Co., Inc. and Pfizer Inc; leading AIDS charities such as Broadway Cares/Equity Fights AIDS and Until There's A Cure Foundation; other private donors such as The Haas Trusts; and many generous individuals from around the world. For more information, see www.iavi.org.
About the Collaboration for AIDS Vaccine Discovery
The Collaboration for AIDS Vaccine Discovery (CAVD) is an international network of thirteen Vaccine Discovery Consortia and five Central Service Facilities funded by the Bill & Melinda Gates Foundation to apply new technologies, concepts and approaches to the design of safe and effective preventive vaccines against HIV/AIDS.
This collaborative effort was established in July 2006 and now includes 18 grants totaling $327 million over five years, with additional co-funding provided by the Fraunhofer Society and the Ministry of Economic Affairs of Saarland in Germany, and the Swiss State Secretariat of Education and Research. The CAVD supports research priorities identified by the Global HIV Vaccine Enterprise, an alliance of researchers, funders and advocates from developing and developed countries dedicated to implementing a shared scientific plan to accelerate HIV vaccine development.