immunoxel study proposed with us

IMMEDIATE RELEASE
ImmunoXel Study Proposed with US
Research Institute
20 September 2010
? Evaluating ImmunoXel as a therapy for the treatment of HIV/SIV
infection
? Progress of ImmunoXel Commercialisation
Healthcare group, Stirling Products Limited (ASX:STI) is pleased to advise that
following meetings attended by the Company?s Managing Director in Washington
with a major US Government research institute late last month, the Company has
agreed to proceed with a collaborative research study of its unique botanical
immunomodulator, ImmunoXel, to be conducted at the institute.
The study as proposed by the institute will be a significant further investigation of an
initial study that the Institute conducted independently of the Company, the indicative
findings of which were reported on 5 July 2010.
During the last decade, ImmunoXel has been successfully used as a part of
combination therapies for many inflammatory and immunodeficiency conditions. It
has been shown in several published clinical studies that ImmunoXel decreases the
elevated liver enzymes and increases CD4 T-cell counts in HIV infected patients coinfected
with TB or having viral hepatitis.
These clinical studies have indicated that ImmunoXel can decrease viral load as well
as help to achieve better clinical response when combined with standard antiretroviral
and anti-tuberculosis therapy. ImmunoXel has also been found to alleviate
the hepatotoxicity associated with antiretroviral therapy as evidenced by improvement
of liver function tests and to reduce the incidence of HIV related opportunistic
infections and reverse TB-associated wasting.
However, variable degrees of success have been reported with ImmunoXel, likely due
to the lack of standardization of the dose, types of combined treatments, timing of
initiation, and the duration of therapy. A large controlled randomized multicentre trial
has not been performed to formally evaluate the efficacy of this treatment. Before
such trial is initiated, it is important to carefully characterize the immunologic and
virologic effects and to better understand its mode of action. This will be one of the
key objectives of the proposed collaborative research study.
HIV infection, together with tuberculosis, claims more than an estimated 3 million
lives annually [UNAIDS and WHO]. As well as this massive annual toll in human
lives, the ongoing multi-billion dollar financial burden on the developing countries
most effected and on WHO and other global aid organizations continues unabated.
Although highly active antiretroviral therapy (ART) is able to inhibit HIV-1
replication, it provides only a partial immune reconstitution, has toxic side effects, and
is unable to eliminate viral reservoirs. Thus, there is an interest in immune-based
therapies, such as ImmunoXel, that alone, or in conjunction with ART, may be able to
restore immune function and prevent disease progression.
The findings of the earlier study conducted independently by the institute suggest that
in-vitro ImmunoXel increases SIV specific responses and particularly IL2 production
by SIV specific cells. These findings are particularly encouraging as HIV infected
long-term non-progressors have been shown to increase antigen specific immune
responses compared to progressors and specifically shown to have preserved IL2
production. Based upon these encouraging findings, the instute has scoped and
proposed the following collaborative studies that the Company has agreed to
particpate in:
1: To further investigate the mechanism of the action of ImmunoXel in-vitro on SIV
infected and unifected cells.
2: Investigate and assess the immunomodulatory activity of ImmunoXel during SIV
infection and the effect of ImmunoXel on viral load, CD4 T-cell count and immune
activation in chronically SIV infected ART na?ve animals.
3: If warranted through the success of 1&2, the efficacy of ImmunoXel in
combination with ART to improve immune reconstitution during SIV infection will
then be evaluated.
The Company?s Managing Director, Peter Boonen, stated: ?We see this proposed
collaborative study with the US government agency as a significant step forward for
Stirling to be able to validate and better understand the findings of all the early trials
that have demonstrated the extraordinary properties of ImmunoXel. The clinical
responses of patients treated to date strongly indicate that ImmunoXel certainly has
potential as a major breakthrough in the treatment of HIV and TB. For the product to
be accepted as a key treatment adjunct, however, we are required to address the
necessary product approval protocols. This proposed collaboration, to which the
Company has agreed, can certainly contribute to a rapid product acceptance and
adoption if the study findings further support the clinical results to date.?
The Company further advises that over the past several months it has been in the
process of assessing its approach to the positioning and marketing of ImmunoXel.
Despite the fact that it is an all-natural botanical immunomodulation compound that
has successfully demonstrated its extraordinary benefits in a number of clinical trials,
any activity by the Company in its promotion and/or sale with regard to the
prevention or treatment of any disease, is globally highly regulated. As a result of this
situation, any marketing of the product as a dietary supplement with no claims, but
only structure and function claims, introduces a series of complex compliance and
legal considerations that the Company is continuing to work with and progress.
The Company will advise the market accordingly as this situation progresses and also
on formalisation of the study proposed by the US research institute that the Company
has agreed to proceed.
For further information see www.stirlingproducts.net or contact:
Peter Boonen
Managing Director
Stirling Products Limited
Ph: +61 2 9299 9270
E: [email protected]
For all Investor Relations inquiries please contact:
James Moses
Mandate Corporate
Ph: +61 420 991 574
E: [email protected]