|
| |
| |
|
 |
Virax gets
green light for commencement of Phase II US clinical trials of VIR201 |
Melbourne, Australia, 17th November 2006 - Virax Holdings Limited (ASX:
VHL) today announced the US Food and Drug Administration (FDA) have allowed an
Investigational New Drug (IND) application for the Phase II testing of the
Company’s VIR201 vaccine for treatment of HIV/AIDS.
The IND application drew on data from the Phase I and IIa trials conducted in
Australia, which showed that VIR201 suppressed the HIV viral load in patients by
up to a factor of ten.
VIR201 is the only therapeutic vaccine based on stimulating the immune system
known to have shown such a positive effect in suppressing virus levels in HIV
infected patients in controlled clinical trials.
Many aspects of VIR201 product development including manufacture and quality
control testing, pre-clinical development, including safety and efficacy tests
and the design, and performance of the clinical trial have been reviewed by the
FDA as part of this process.
Commenting on the announcement today, Virax Chief Executive Officer Dr. David
Beames said, “This is a very significant achievement for Virax. We are one of
only a few Australian companies to have a Phase II trial application allowed by
the FDA”.
“We firmly believe that our Co-X-GeneTM technology is unique and significant,
and VIR201 has the potential to significantly improve the medical outcomes for
millions of HIV sufferers. Confirmation of our present results in a larger trial
with a broader patient population would be a transforming event for the Company.
This would be an important step in the development of an exciting new class of
drug to treat HIV, currently a US$8.0 billion market and growing at more than
10% a year”.
Commencement of the Phase II trial is subject to the availability of sufficient
funds to conduct the trial. The Company is currently pursuing all available
options, including admission to the Alternative Investment Market (AIM) in
London, for funding the Phase II VIR201 studies.
The proposed US trial is in addition to the Phase I/IIa trial of VIR201 planned
for the developing world. An application to conduct a trial in South Africa was
submitted to the South African Medicines Control Council in September 2006.
Virax has received funding pledges from Melbourne-based BHP Billiton as well as
several major South African and international corporations. These pledges of
financial support will enable the South African trial to proceed once approval
from the MCC and other regulatory bodies has been secured.
The Virax Board firmly believes that VIR201, based on Co-X-GeneTM technology is
a unique and potentially important new approach to treating HIV. The
availability of additional, positive trial data will add significant value to
the Company.
- ENDS -
About Virax
Headquartered in Melbourne, Virax Holdings Limited is a biotechnology company
engaged in the development of some of the world’s most promising treatments for
diseases such as HIV/AIDS, prostate cancer, hepatitis B and other infectious and
autoimmune diseases.
Virax’s focus is on technology that underpins the development of immune-based
therapies (immunotherapy) – therapies that use biological signals to direct the
immune system to treat disease.
For further information contact:
Media: Investors:
Adam Michael
David Beames CEO,
Northbank Communications
Virax Holdings Limited
+44 (0)20 3008 7550
+61 (0)3 9854 6230
a.michael@northbankcommunications.com
| |
|
