Is this article true ?
If this is considered Spam, please accept my appologies.
It sounds like a hoax, since I've never heard about it on the news.
Fra: "immunitor immunitor" <immunitor3 at hotmail.com>
Emne: V-1 IMMUNITOR
Dato: 16. april 2002 10:33
Trial to be conducted on 100 patients suffering from HIV/Aids
Critics say tests are unethical
Physicians at Rajavithi hospital are preparing for a trial of V-1 Immunitor
on more than 100 people infected with HIV/Aids.
The trial would be spearheaded by Dr Oraphan Methadilokkul, chief of the
Office of Occupational and Environmental Medicine at the hospital, who
earlier carried out a study on hundreds of patients who have taken V-1
Immunitor at Ban Bangpakong clinic and Wat Phra Baat Nam Phu. Most patients
reportedly got better after receiving the product while only 10% got worse.
V-1 Immunitor was registered as a food supplement with the Food and Drug
Administration, but its inventor Vichai Jirathitikal, wants it upgraded.
Dr Oraphan said the patients who got better were generally younger, had
short-term infection of not more than one year, never received
anti-retroviral drugs and were mostly women.
Since the study proved positive, it was necessary to continue the trial into
the next phase, which would prove if V-1 caused the improvement.
Dr Oraphan said she was planning two trial projects under the placebo
control method. One of the projects would involve 100 volunteers who were
asymptomatic HIV-positive. The volunteers must meet criteria such as having
CD4 count at more than 450, with CD4/CD8 ratio not less than 0.5, having low
level of viral load, and aged between 20-50.
This trial would be conducted at Rajavithi hospital and would take one year
to complete. Dr Oraphan said the hospital director was reluctant to permit
the trial but finally allowed it to proceed.
The other trial was expected in 20 symptomatic HIV sufferers who have the
symptoms of cachexia, but not yet experienced opportunistic infections such
as tuberculosis, or brain and lung infections.
However, since this trial was involved with symptomatic patients, she was
concerned it would not pass the hospital's ethic panel, and therefore
planned to move the trial to other hospitals such as Police hospital or
Bamrat Naradura hospital.
Dr Oraphan explained that in both trials, half of the volunteers would
receive V-1, while the other half would receive placebo unknowingly. This
double-blind study was to prove whether the patients could get better
treatment from V-1.
As president of the Society of Thai Occupational and Environmental Medicine,
Dr Oraphan yesterday organised a seminar on V-1 Immunitor to present various
studies about the substances.
Tasanee Lakhanapichonchat, of Thammasat University's Faculty of Social
Science, who conducted a study on 1,200 patients at Ban Bangpakong clinic
between August and September, was also surprised at the positive results.
She said 49% of the interviewees felt they could eat better after receiving
V-1, 43% said they gained hope and spiritual strength, 35% gained weight,
another 35% could work, 24% feel fresher, while 17% said skin rashes were
relieved or even vanished.
V-1 immunitor became controversial after its inventor started to distribute
the product to HIV/Aids patients last year. Its opponents argued the
manufacturer exaggerated the product's efficacy since there was no
scientific evidence to clearly prove that V-1 could cure HIV/Aids.
The Medical Council ruled against the product, causing dissatisfaction among
Dr Dwip Kitayaporn, professor in Epidemiology at Mahidol University, said he
did not believe V-1 had any beneficial effect.
He also warned that Dr Oraphan's trial on humans would breach medical ethics
if it was conducted without approval of the Public Health Ministry's ethics
``Before any trials, a researcher should have a prior study in animals to
prove safety of the substance,''said Dr Dwip.
Immunitor Company Announces Publication of V-1 Immunitor Clinical Results
Immunitor Press Release
Immunitor Company announces the publication of an open label trial of V-1
Immunitor (V1) in a peer-reviewed medical journal published in the USA. The
scientific paper entitled "Safety and efficacy of an oral HIV vaccine (V-1
Immunitor) in AIDS patients at various stages of the disease" appeared in
bimonthly January-February issue of HIV Clinical Trials
(http://www.thomasland.com ). Paper describes that HIV-positive patients
given experimental oral HIV vaccine, showed strong evidence of clinical
benefit. Even more important to the field of vaccine research is the fact
that, V-1 Immunitor has already been given to more than 50,000 AIDS patients
in Thailand - the largest number in AIDS vaccine history. The mass
distribution of V1 was supported by Salang Bunnag Foundation -
non-government organization based in Thailand.
Main clinical endpoints in the study were safety of V1 and differential
effects on CD4 and CD8 cell counts, plasma HIV RNA levels, and body weight
change. Following V-1 Immunitor administration, the number of CD4 T
lymphocytes increased so is the number of CD8 cells, which thought to
provide cell-mediated immune response and now considered as critical arm of
immunity in the fight against HIV. Following six months on V1 the mean
increase in absolute CD4 and CD8 cells was 51 (18%; p=0.0088) and 172(16%;
p=0.0199) cells per cubic millimeter of blood. Viral load measurements in
eight patients have shown statistically significant trend in decrease
(Spearman correlation test: r=0.96; p=0.0005). The mean body weight gain
following V1 administration was 2.2 kg (p=0.0004). Statistical probability
values of obtained data indicate that changes due to V1 administration
cannot be attributed to a simple coincidence.
Classic injectable vaccines have the major disadvantage of relying on
syringes as the mode of delivery. Patients who are frequently exposed to
injections run risk of having life-threatening infections. Almost every AIDS
vaccine currently under development is injectable since development of
reliable oral delivery is a major challenge for vaccine industry. Immunitor
technology has been able to overcome the problem of delivery. It is likely
that V-1 Immunitor will be more acceptable alternative for the treatment of
diseases, such as HIV, because they are more suitable for administration
especially in developing countries, which often lack most basic medical
V-1 Immunitor is a novel vaccine platform technology that enables oral
delivery of virtually unlimited number of immunogen types. Immunitor
immunogens are formulated into an ordinary looking pill in a such way that
they can withstand the digestive degradation in the stomach but are capable
to trigger immune response once presented by the gut cells. The vaccine
induces the cellular immune response in the mucosal environment as a means
to treat, control or prevent disease. This ability to preferentially target
mucosal immune system is a major breakthrough. Any type of disease which
requires mucosal immune response, such as infectious diseases, cancer,
autoimmune diseases, allergic asthma and allergy, are potential candidates
for this technology.
In addition to V1 the Immunitor Corporation developed novel immune-based
treatments for cancer, microbial and fungal diseases. These products
represent the next generation of vaccines which are deliverable orally.
According to the Joint United Nations Program on HIV/AIDS, today there are
36.1 million people estimated to be living with HIV/AIDS. Of these, 34.7
million are adults and 1.4 million are children under 15. An estimated 21.8
million people have died from AIDS since the epidemic began. During 2000,
AIDS caused the deaths of an estimated 3 million people, including 1.3
million women and 500,000 children. Approximately 47%, or 16.4 million, of
adults living with HIV or AIDS worldwide are women. Over 95% of people with
HIV now live in the developing world without access to antiviral drugs.
Vichai Jirathitikal, the inventor of the technology said, "Our vaccine
represents a whole new way of treating patients in the future. People die
every day and most cannot afford expensive antiviral drugs. V-1 Immunitor is
valuable, life-saving and safe alternative to our patients. Our publication
demonstrates the value of Immunitor core technology for the identification
of treatment for a variety of human diseases and the discovery of novel
potential drug targets. Placebo controlled study is the next step to advance
further development of V1".
V-1 Immunitor is currently under investigation in several Asian countries
including China, Burma, Cambodia, Laos, India, Malaysia and some countries
in Africa. V1 distribution campaign was initiated as a popular grass-roots
movement that has started in Thailand in the summer of 2001 (see for details
in "V-1 Immunitor: Grass-Roots AIDS Initiative in Thailand". M. Satarayak
and T. Laknapichonchat (Eds), Thammasat University, 2001 Seven Printing
Group, ISSBN 974-572-907-8).
For reprints contact: Dr. Aldar S. Bourinbaiar; tel: 66-01-931-0116; fax:
1-775-640-6636; email: immunitor at aol.com
The downloadable PDF copy of the article can be found at Publisher's website
Copyright 2002 Immunitor Company
Permission to reprint this release granted by Dr. Aldar S. Bourinbaiar,
Immunitor Company website (currently under construction)
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