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:
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12531330&dopt=Abstract
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, is 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
(www.dnavaccine.com/new.html?aid=610).
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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