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Phase II Placebo-Controlled Study of V-1 Immunitor in VACCINE Journal

immunitor immunitor at aol.com
Thu Jan 30 05:16:31 EST 2003

Phase II Placebo-Controlled Study of V-1 Immunitor in VACCINE Journal

Researchers of Thailand-based Immunitor company announce the
publication of results of placebo-controlled, Phase II clinical trial
entitled ‘V-1 Immunitor: oral therapeutic AIDS vaccine with
prophylactic potential’ in January 30, 2003 issue of VACCINE
– the top scientific journal in the field (Vol. 21(7-8): pages
624-628). The link to the abstract of the paper at the website of the
National Library of Medicine of the NIH is as follows:

This study is a result of collaboration with the clinical team led by
epidemiologist Dr. Orapun Metadilogkul of Rajavithi General Hospital,
the largest public medical institution of the Thai Ministry of Public
Health. In this trial V-1 Immunitor (V1) has been investigated as a
preventive AIDS vaccine in 35 healthy, non-infected individuals.
Twenty HIV-negative volunteers immunized with V1 gained 28.2% and
17.5% in absolute CD4 (825 versus 1058; P=0.007) and CD8 (597 versus
702; P=0.013) cells, while lymphocytes in the placebo group did not
increase, suggesting that a rise in CD4 and CD8 counts will be an
easily measurable immune correlate of the efficacy of the AIDS
vaccine. At the same time V1 did not induced HIV-specific antibodies
as orally administered immunogens usually produce cell-mediated but
not systemic humoral response. Currently, no other oral AIDS vaccine
is available that has been tested in humans. The closest product,
planned for clinical studies, an IAVI-sponsored vaccine being
developed by a research team of Dr. Robert Gallo – the
co-discoverer of HIV.

V1 consists of a cocktail of fragments of HIV proteins derived from a
large pool of specially processed blood from HIV carriers. These
protein fragments or antigens are harmless since they are inactivated
by heat and chemical means and are then formulated into an
ordinary-appearing pill. When taken orally, V1 produces an immune
response on mucosal surfaces as evidenced by rising T cell counts.
Since HIV also enters the body through the mucosal surface of the
vagina or rectum, a proper immunological response at the site of virus
entry is the best chance to prevent infection in a rational manner.
The vaccine as designed offers unique advantages: (1) it is safe; (2)
has a broad-spectrum activity against any HIV species at any
continent; (3) very large quantities can be manufactured at low cost;
(4) it is extremely stable at ambient tropical temperature, thus
eliminating the need for refrigerated storage and reducing the cost of
transportation; (5) it is easy to administer (no syringes and no risk
of being infected with contaminated needles); and (6) it does not
require specially trained personnel for mass-distribution campaigns.

The vaccine, the first of its kind to originate from a developing
country, is currently manufactured in Thailand. V1 is licensed by the
Thai FDA as dietary food supplement for special purposes and also has
a permit as an R&D drug. As of today, over 12 million units of V1 have
been made and used by 60,000 AIDS patients in Thailand and
approximately 4,500 individuals in 50 countries around the world.
According to results of Phase I trial reported in the peer-reviewed
journal HIV Clinical Trials in early 2001, in a study involving 40 HIV
infected individuals, orally administered V1 boosted CD4 and CD8
lymphocyte counts, decreased viral load, and reversed AIDS associated
wasting (www.thomasland.com/_nonsearch/hct03104.pdf). In the
subsequent study on 117 patients as reported in May 2002 in the same
journal, administration of V1 to terminally ill, end-stage AIDS
patients has resulted in prolonged survival and return to normal life,
while all those who declined treatment were dead within two months
(www.thomasland.com/_nonsearch/hct03310.pdf). V1 also appears to be
beneficial to patients with viral hepatitis

According to the United Nations Programme on HIV/AIDS (UNAIDS) about
14,000 people worldwide are infected with HIV every day. In developing
countries, where therapies are not readily available, HIV diagnosis is
a death sentence. Of the 3 million deaths attributed to AIDS in 2001,
2.2 million occurred in Africa. Several large pharmaceutical firms,
e.g., Aventis, Chiron, GlaxoSmithKline, Merck, Wyeth, and a dozen of
smaller companies are working to advance their candidate HIV vaccines
into human trials. However, only two AIDS vaccines, one by VaxGen and
another by Immune Response Corporation, have reached late-stage trials
involving several thousand volunteers.

‘This year we will start Phase III trial in Africa in accord
with our strategy of going where there is a need,’ said Mr.
Vichai Jirathitikal, who is a pharmacology graduate of Mahidol
University in Bangkok and the principal developer of the vaccine.
‘We are currently running pilot therapeutic trials in eight
African countries as part of the feasibility study. So far, the
response from patients and clinicians has been enthusiastic; V1
appears to benefit even those who have HIV-2, a distant cousin of HIV.
We are also discussing plans to build a plant in one of these
countries as part of our long-term goal to provide self-reliance and
independence to our allies. We want our technology to be affordable in
third world countries. Our goal is to save lives; money is tangential.
We have given V1 free-of-charge to 40,000 people in Thailand.’

‘The paper in VACCINE represents the culmination of many years
of groundwork in basic science to understand how the virus spreads in
the mucosa and a succession of preclinical and clinical studies in
spite of the enormous hurdles of developing vaccine without adequate
support,’ commented Immunitor’s Scientific Director, Dr.
Aldar Bourinbaiar, who was involved in HIV research since 1983.
‘As opposed to start-up biotech companies, primarily depending
on research grants and venture capital, we have a commercially viable
line of proprietary products that sustain our activity, albeit at very
modest level. This is and will be an uphill struggle but we are
optimistic about seeing enrollment in a Phase III trial happening
before end of this year. We hope that such a study will bring us one
step closer to the ultimate goal of ending the AIDS pandemic.’
For further information please contact immunitor at aol.com.

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