Important note: Information in this article was accurate in 2000. The state of the art may have changed since the publication date.
PRNewswire - Monday November 27, 2000
The trial, to be conducted in Melbourne and Sydney, will use Co-X-GeneTM technology, a unique vaccine delivery method invented by Australian researchers. Dr. David Beames, CEO of Virax, said, "Our first clinical trial (to treat people infected with HIV) is the culmination of years of research and pre-clinical development studies."
"With this ethics committee approval patient recruitment can now commence. We are forging new paths in the global search for better ways to treat HIV/AIDS, capturing value for the nation through development of Australian research, and building Australia's clinical drug development expertise."
Virax's HIV vaccine trial will be a multi-centre, double blind, controlled, randomised, parallel group study in 36 patients to evaluate Virax's Co-X-GeneTM with fowlpox virus (FPV) technology in humans. The Phase I/IIa trial is designed to evaluate the safety of Virax's vaccine, VIR201, and its ability to enhance killer T cells in early stage HIV patients. The trial will be conducted in association with the National Centre in HIV Epidemiology and Clinical Research. International basic and clinical research for the treatment and prevention of HIV/AIDS continues to point to the validity of the vaccine approach.
The vaccine to be tested, VIR201, is a live viral vector vaccine based on the Company's platform technology, Co-X-GeneTM with FPV, a method for delivering vaccines. Platform technologies are often used to address a broad range of diseases or potential products. VIR201 uses a FPV to carry genes from the HIV virus and a human cytokine to cells in the human body to trigger a directed immune response.
Patients will receive a series of injections and be closely monitored over 12 months. When the trial is complete, Virax will announce the results. If the trial shows the predicted immune response, Virax may seek an international biopharmaceutical partner to fund further studies to show its effectiveness in larger, later stage studies.
Virax has acquired the exclusive development rights to the patented Co-X-GeneTM with FPV technology from CSIRO and ANU's John Curtin School of Medical Research. The licence permits Virax to develop and commercialise applications of the Co-X-GeneTM with FPV technology within the field of human health.
Earlier this year, it was announced that Virax is part of an Australian consortium that is receiving contract funding from the US National Institutes of Health to develop vaccines to prevent HIV/AIDS. Virax's HIV vaccine trial announced today is a treatment trial. Vaccines to be tested in both prevention and treatment trials use Virax's Co-X-GeneTM with FPV platform technology.
HIV/AIDS is well recognised as a global emergency. More than 34 million people are living with HIV/AIDS and by the end of 1999, almost 19 million men, women and children had died. It has been estimated that 5.4 million people were newly infected with HIV in 1999. Ninety-five percent of all new infections are in developing countries. Current scientific consensus suggests that vaccines offer the best prospects for ending the HIV/AIDS epidemic.
Melbourne-based Virax Holdings Limited is a publicly listed (ASX:VHL) development stage biotechnology company engaged in immunotherapeutics for HIV/AIDS and other infectious diseases, cancer, and autoimmune diseases.
Virax's business strategy is to identify and in-license promising early stage biotechnologies, and conduct R&D followed by early stage clinical trials to demonstrate commercial value. Visit Virax's Web site at www.virax.com.au for more information regarding immunotherapeutics and the Co-X-GeneTM with FPV technology platform.
Co-X-GeneTM is a trademark of Virax Holdings Limited. SOURCE: Virax Holdings Limited
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