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Is this true ?? Just curious.

Tim none at none.com
Tue Apr 30 03:35:54 EST 2002

It's interesting that a search of the FDA website, using the term
"Immunitor" gives 0 hits.  A search on "V-1" gives numerous hits for
procedural documents and illustrations, but I didn't see a specific
reference to this compound (maybe I missed it - perhaps the company can
provide you with a copy of the registration).  The journal is not generally
regarded as "upper tier".


""Brian"" <zhil at online.no> wrote in message
news:8E9x8.4532$2E.135766 at news2.ulv.nextra.no...
> 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.
> Brian
> --------------------------------------------------------------
> Fra: "immunitor immunitor" <immunitor3 at hotmail.com>
> Dato: 16. april 2002 10:33
> Trial to be conducted on 100 patients suffering from HIV/Aids
> Critics say tests are unethical
> Anjira Assavanonda
> Physicians at Rajavithi hospital are preparing for a trial of V-1
> 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
> reportedly got better after receiving the product while only 10% got
> 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
> 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
> CD4 count at more than 450, with CD4/CD8 ratio not less than 0.5, having
> level of viral load, and aged between 20-50.
> This trial would be conducted at Rajavithi hospital and would take one
> 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
> 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
> Dr Oraphan yesterday organised a seminar on V-1 Immunitor to present
> 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
> 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
> 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
> V-1 supporters.
> Dr Dwip Kitayaporn, professor in Epidemiology at Mahidol University, said
> did not believe V-1 had any beneficial effect.
> He also warned that Dr Oraphan's trial on humans would breach medical
> if it was conducted without approval of the Public Health Ministry's
> panel.
> ``Before any trials, a researcher should have a prior study in animals to
> prove safety of the substance,''said Dr Dwip.
> News/Event Item
> 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.
> 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
> 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
> 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
> vaccine currently under development is injectable since development of
> reliable oral delivery is a major challenge for vaccine industry.
> 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
> diseases, such as HIV, because they are more suitable for administration
> especially in developing countries, which often lack most basic medical
> supplies.
> 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
> 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
> 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
> 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
> 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
> valuable, life-saving and safe alternative to our patients. Our
> 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
> 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
> 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
> http://www.thomasland.com
> Copyright 2002 Immunitor Company
> Permission to reprint this release granted by Dr. Aldar S. Bourinbaiar,
> Immunitor Company
> Immunitor Company website (currently under construction)
> http://www.immunitor.com
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