|
Publication of VIR201 Phase IIa trial results in peer reviewed scientific journal |
|
|
|
19 Jul 2007 |
VIR201 Phase IIa clinical trial results paper to appear in Human Vaccines journal
MELBOURNE, Australia | July 18, 2007 | Virax Holdings Limited (ASX: VHL) announces that it has received notification that the paper presenting the results of its VIR201 Phase IIa human clinical trial has been accepted for publication in the scientific journal "Human Vaccines"The full paper will appear in the Jan/Feb 2008 edition (Vol 4 Issue 1) of Human Vaccines.
The Abstract of the 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 available now from the journal's web page at: http://www.landesbioscience.com/journals/vaccine/article/4627
This is the second scientific peer reviewed paper dealing with results from this important VIR201 clinical trial (please note background section below)
Virax is developing VIR201 as a therapeutic vaccine for the treatment of HIV/AIDS. The therapeutic vaccine approach of stimulating the immune system is in contrast with the existing anti-retroviral treatments that directly target the infecting HIV virus.
Worldwide sales of HIV/AIDS therapeutics were US$7.1 billion in 2005 and are expected to reach US$10.6 billion by 2015 (Datamonitor Report, April 2007).
The Phase IIa trial of VIR201, sometimes referred to as the "Extension Study" because it followed on from a Phase I (safety) trial, demonstrated that when compared with placebo, VIR201 was able to suppress reappearance of the HIV virus after anti-retroviral therapy was discontinued. The HIV virus levels in the placebo treated patient group were more than 6 times higher than the VIR201 treated patient group.
Two of the ten patients in the VIR201 arm of the trial had a reduction of 2 logs (a factor of 100) in viral load compared to the placebo arm. In addition two patients out of a number who joined a follow up group had not returned to their anti-retroviral therapy for a total of 200 weeks from the trial start.
The results from these trials have been reviewed and assessed by a number of expert groups including the FDA which has granted VIR201 IND (Investigational New Drug) status for a Phase II trial in the USA at higher dose levels than employed in these initial trials. Nevertheless, publication in a peer reviewed scientific journal is the first public acknowledgement of the quality of these important trial results and further validation of the science underlying the Co-X-Gene(tm) Technology and VIR201
SOURCE: Virax Holdings Limited |
