VIR201 Phase IIa Trial Results Now Published in Peer Reviewed Scientific Journal – Human Vaccines
• VIR201 Phase IIa clinical trial results appear in Human Vaccines journal
MELBOURNE, Australia, 6 February 2008--As communicated to shareholders in the Company’s announcement of 18 July 2007, the Company received notification that the paper presenting the results of its VIR201 Phase IIa human clinical trial was to be published in the scientific journal “Human Vaccines”.
The full paper entitled “Influence of IFN? Co-Expression on the Safety and Antiviral Efficacy of Recombinant Fowlpox Virus HIV Therapeutic Vaccines Following Interruption of Antiretroviral Therapy” is now in print and appears in Vol 3 Issue 6 of Human Vaccines, pages 260-267.
Publication in a peer reviewed scientific journal is acknowledgement of the quality of these important trial results and further validation of the science underlying the Co-X-Gene™ Technology and VIR201. This paper contains data that has not until now been available in the public domain. A copy of the paper is attached and can also be viewed on the Company’s website (www.virax.com.au).
VIR201 which utilises Virax’s proprietary Co-X-Gene™ Technology and fowlpox virus technology is being developed as a therapeutic vaccine for the treatment of HIV/AIDS. The manuscript describes in detail the ability of VIR201 to suppress reappearance of the HIV virus when individuals infected with HIV discontinue anti-retroviral therapy. This was not observed when HIV infected individuals were vaccinated either with placebo (salt solution) or a related recombinant fowlpox virus that did not utilise Co-X-Gene™ technology. Because of this encouraging data Virax is planning to further develop VIR201 with a clinical trial planned for South Africa where it is currently awaiting regulatory approval.
Virax, based in Melbourne, Australia, is a biopharmaceutical company engaged in the discovery and development of novel immunotherapeutic products for the treatment of chronic infectious diseases and cancer. The Company’s lead product, VIR201, an HIV/AIDS immunotherapeutic (therapeutic vaccine), recently cleared by the U.S. FDA to begin Phase II trials, has completed two successful clinical trials in Australia with additional international studies planned. The Company has also submitted an application to the South African regulatory authority (MCC) to conduct a Phase I/IIa trial of VIR201. Funding for the African trial has been contributed by a consortium of global and South African resource companies led by BHP Billiton.
In March 2007 Transgene (Eurolist Paris: FR0005175080) executed a Licence Agreement with the Company for access to Co-X-Gene™ technology for use in two of Transgene’s immunotherapeutic products. These are TG4001 – a treatment for pathologies relating to human papilloma virus (HPV) infection that can lead to cervical cancer - and TG4010 – a treatment for non-small cell lung cancer. This was reported to the ASX in the Company’s announcement of 13 March 2007 and is referred to as the “Transgene Sub-licence”. Both TG4001 and TG4010 are in advanced development with Phase III trials of TG4001 planned for 2008 and Phase IIb studies of TG4010 currently underway. Transgene has licensed TG4001 to the pharmaceutical company Roche for treatment of HPV related pathologies.
Additional information about Virax is available at www.virax.com.au
For further information contact:
Dr Larry Ward John Morrison
CEO, Virax Holdings Limited CFO, Virax Holdings Limited
Melbourne, Australia Melbourne, Australia
(03) 9854 6230 (03) 9854 6230
Please see the attachment for more information.
Posted: February 2008