V1 Immunitor

Press Release: "Immunitor's breakthrough in cancer immunotherapy" - June 25, 2014 Perhaps your website can be updated to discuss all the recent positive results from several clinical trials with tuberculosis, published in several different journals. Most recently, our results with terminal liver cancer have been made public, but a controlled trial is still in progress. The press release is the only public information on this new use of an Immunitor oral vaccine.
The Immunitor site is updated and back online - January 3, 2011
From the site: Immunitor products are used as means of preventing and/or treating viral infections such as HIV, hepatitis B and C, influenza, tuberculosis, broad spectrum bacterial and fungal infections, cancer; and atherosclerosis/obesity. They are now up to V-5. A list of the latest publications is here and they claim it may be working: Nevertheless, it is clear that obtained results are highly unusual. Why would previously HIV-antibody-positive patients become seronegative after treatment with V1?...

Immunitor site finally gone? - February 7, 2009
It appears that the website of Thai AIDS cure is finally offline. Archive of the site.


V1-Immunitor: Surapong: I didn't break my promise - The Nation, July 22, 2006
Dr Oraphan Methadilokkul, a proponent of the controversial V1-Immunitor pills, which are registered as a food supplement and promoted as a treatment for HIV-Aids, yesterday went to Surapong's house and requested the Bt1 million.
Oraphan said Surapong promised to pay her to withdraw the suit she filed against him four years ago when he was deputy minister of public health.
It was during this time that several newspapers published articles in which Surapong said V1-Immunitor was unable to cure HIV-Aids patients as claimed by the supplement's maker...


Press release from Immunitor - December 15, 2004

Immunitor Announces Placebo-Controlled Trial of Its Therapeutic AIDS Vaccine
College Park, MD -- Immunitor USA Inc., announces that its licensed vaccine candidate V-1 Immunitor (V1) has shown promising results in Phase II, placebo-controlled, clinical trial involving 47 HIV-infected individuals (http://www.emediawire.com/releases/2004/12/emw186195.htm)
The study was published in the special December issue of the Journal of Clinical Virology – the official journal of The Pan American Society for Clinical Virology and The European Society for Clinical Virology. The abstract of the paper is now available on PubMed - the website of the National Library of Medicine.
At the end of 6-month study volunteers who were treated with V1 had statistically significant increase in CD4-positive T-cell numbers (p=0.01). However, in the placebo group that has received sham pills, the changes in T-cell counts failed to reach the significance threshold (p=0.33). The clinical potential of V1 was further supported by an elevation in CD4/CD8 ratio among V1 recipients and decline in CD4/CD8 ratio in patients on placebo. The average weight gain among patients on V1 was 1.8 kg while placebo group lost 0.5 kg. These results indicate that V1 can delay or reverse the HIV disease progression without any concurrent toxicity.
"Our published data supports earlier published, Phase I studies of V1 demonstrating increase in T-lymphocyte numbers, decrease in viral load, body weight gain, and improved survival of end-stage AIDS patients,” said Vichai Jirathitikal, the inventor of the oral vaccine technology. "The study provides additional evidence that this type of vaccine might ultimately be effective as a safe and effective treatment for AIDS and potentially other autoimmune diseases as well."
"The very first clinical study of V1 was published in 2002. In just two years we were able to achieve the major milestone in drug development process, which is the pivotal Phase II trial. We have accomplished this despite major and obvious difficulties and we are looking forward to confirm such results in Phase III clinical trial," said Dr. Aldar S. Bourinbaiar, CEO.
Due to toxicity and drug resistance problems associated with conventional antiviral chemotherapy, the therapeutic use of AIDS vaccines is receiving increased attention in the medical community. There has been considerable experience with this type of approach, with several dozen clinical trials reported over the last twenty years. While the immune response appeared to change as a result of therapeutic vaccination in most, if not all studies, there was no demonstrable clinical benefit. Despite this setback many clinical studies of various therapeutic vaccines are in progress, which may eventually help to identify an effective strategy.
V-1 Immunitor is an experimental AIDS vaccine made as an ordinary pill and comprises heat- and chemically-inactivated viral antigens derived from the pooled blood of HIV-positive donors. V1, which is taken orally on a daily basis, is thought to function by modulating the mucosal immune response. This innovative method of vaccine administration places the emphasis on oral tolerization of alloantigens delivered through the gut. V1 is the first therapeutic AIDS vaccine that has shown the clinical improvement in AIDS patients when administered orally.

V-1 mentioned in Nature - January, 2004
AIDS wasting: V-1 Immunitor treatment
AIDS-related wasting is a common complication of HIV infection and despite being recognised as one of the main predictors associated with subsequent debilitation and death, there is no standard treatment. In this month's European Journal of Clinical Nutrition, Jirathitikal et al. focus on V-1 Immunitor therapy for wasting as a safe, effective and most importantly affordable treatment developed in Thailand. They present their retrospective study of body weight changes in 650 antiretroviral-drug na?ve AIDS patients treated with V-1 Immunitor. This article highlights the comprehensive success of V-1 Immunitor therapy; including the good clinical response shown in patients, the reversal of wasting through reduced rates of opportunistic infections, increase in appetite, sense of taste and the ability to eat solid foods, and importantly the relative affordability of the treatment.

Immunitor responds to negative Post news about V-1 - January 21, 2004
Immunitor Corporation, Co., Ltd. responds to two recent articles in the Bangkok Post concerning people being arrested for selling V-1 tablets:

Dear Sir,

The front-page story “Four held for V-1 pill sales” by Anucha Charoenpo (Bangkok Post, 01.18.04) is highly biased and does not attempt to provide any objective exposure on V-1 Immunitor. The last time when your newspaper presented a fair view on V1 was on June 10, 2001 and this was largely due to reporter’s having a degree in biochemistry and research experience in the medical field. During last three years we have witnessed the continuous campaign of slander and libel without any sign of basic professional journalism, i.e., failure to give readers the opinion from both sides or lack of analysis as to why or in whose interest V1 is being persecuted. Calling V-1 Immunitor as a “scam” (legend on the photo by Apichart Jinakul) without any evidentiary support is an outrageous statement, which does not fit the image of respectable newspaper like yours.

Khun Anucha states that “public health authorities have declined to register it as a drug”. This statement is a plain lie. V1 has a pending R&D drug status (Permit No. 1A1874/43 which was issued on September 2000 by the Ministry of Public Health (MOPH). In regard to the food supplement license issue our response has already been published in your newspaper earlier (see for unabridged version of the letter to the Editor at V1 news website http://www.2bangkok.com/2bangkok/v-1.shtml)

So, what is the true meaning of said authorities declining V1 registration as a drug? Is it because MOPH declared (Bangkok Post 08.29.02) that V1 is “useless”? The only official study that purportedly tested the efficacy of V1 has been carried out in August 2001 by MOPH’s investigative committee. However, this study is fraught with three major problems which are as follows: First, three members of the six-member MOPH committee which evaluated V1 were investigators of an AIDS vaccine trial sponsored by overseas company, clearly implying the conflict of interest in what it was supposed to be an objective investigation; Second, and most important, MOPH carried out a single, one-time test of CD4/CD8 T-cell counts and viral load, which for obvious reasons is not sufficient to judge product efficacy. Without any knowledge of the patient's status before treatment initiation how can one tell if V1 is effective? That kind of testing is of little credence to those who are familiar with the basics of scientifically sound inquiry; Third, the final report of the committee has not stated anywhere that V1 is "useless". This was, again, the interpretation of the media and corrupt MOPH officials but not of the committee members. The Chief of the Communicable Diseases Control Department, Dr. Somsong Rakpao, the head of the investigative committee and one who announced that V1 was useless, was removed from his active duty on bribery charges shortly after his announcement (Bangkok Post 08.31.01). What was said in the original conclusion of the committee is that V1 is safe and with available to them efficacy data they cannot make a conclusion and thus further study is required. No further study ever followed. All subsequently repeated declarations by MOPH officials, i.e., by Deputy Health Minister Dr. Surapong Suebwonglee, that V1 is useless were based on flawed August 2001 study (The Nation 09.06.02). Our lawsuit against Dr. Surapong was dismissed by government’s Civil Court which ruled out that Dr. Surapong merely stated the “facts”. So, where are those facts?

During last three years we have published several peer-reviewed scientific papers in reputable international medical journals, which have demonstrated the safety and clinical efficacy of V1. We were also invited to present these data at major international AIDS conferences – a demonstration of V1 recognition by our peers. This evidence is in the public domain and is freely available to anyone who might be interested to investigate further (e.g., HIV Clinical Trials 2002; 3:21-26; HIV Clinical Trials 2002;3:258-259; Antiviral Therapy 2002;7:L115-116; Journal of Human Virology 2002;5:88-89; Current Pharmaceutical Design 2003;9:1419-1431; Vaccine 2003,21:624-628; Electronic Journal of Biotechnolofy 2003;6:76-79; Viral Immunology 2003;16:427-445; European Journal of Clinical Nutrition 2004;58:110-115). In the professional medical field a peer-reviewed publication is the only valid proof and it certainly prevails over “facts” cited in lay media. MOPH is suspiciously silent on this evidence and has never even acknowledged its existence.

The obvious question, who is interested in this? Immunitor Corporation, is a private biotech company that receives no support from the Thai government. The $100 mln/year Government Pharmaceutical Organization (GPO), the half of which is owned by MOPH, produces cocktail anti-HIV drug called GPO-VIR which consists of three generic reverse transcriptase inhibitors, Nevirapine, Stavudine and Lamivudine, but without any protease inhibitor – a critical component in HAART therapy that has shown success in AIDS treatment (Bangkok Post 03.22.02). Immunitor is perceived by MOPH as a competitor of GPO. This perception is not without ground since AIDS patients in Thailand prefer to be treated with V1 rather than with antivirals. Today in Thailand 60,000 patients have been treated with V1 as opposed to 5,000 and counting on GPO drugs. MOPH’s Permanent Secretary Dr. Vallop Thainua admitted that the main reason for low enrolment were “allergic reactions” caused by GPO drug (Bangkok Post 11.22.02). The adverse reactions induced by GPO drug led the former Deputy Health Minister, Surapong Suebwonglee, to ban (sic!) their sale in pharmacies and to declare that “Allowing pharmacies to supply these drugs risks detrimental effects to those infected with HIV or Aids” (Bangkok Post 09.16.02). Due to lukewarm reception of government-sponsored drugs currently only 60% of local Thai hospitals have anti-HIV drugs on hand (Bangkok Post 03.10.03). While patients’ inadequate drug adherence and toxicity problems are inherent to the nature of antiretroviral drugs the Ministry lays blame, albeit unjustly, on Immunitor (Bangkok Post 02.28.03). In the media repeated claims were opined that the mere existence of V1 discourages greater enrolment of AIDS patients into their program (San Francisco Chronicle 08.27.01). Instead of acknowledging and correcting quality problems plaguing GPO’s drugs the government has chosen Immunitor as the main culprit for their failure. Instead of allowing a fair business competition the MOPH uses media and police force to shut us down.

Your story tells us that police and Thai health officials have arrested members of the non-government organization (NGO) called Immunitor Support Society for the distribution of V1. According to Thares Saengsakul – the President of Immunitor Support Society - his NGO lists over 2,000 AIDS patients who represent 60,000 Thai individuals treated with V1. In Thailand there are over 300 AIDS NGO’s, assembled as ‘Thai NGO's Coalition on Aids’ whose goal is to represent people with HIV/AIDS. Despite that both associations have same number of members the difference between so-called “AIDS NGO’s” and Immunitor Support Society is that the former are on the government payroll. According to report by Pothisiri et al., presented at the 12th International AIDS Conference in Geneva Thai NGO’s consume approximately $2.2 mln (90 mln Baht) per year or 10% of Public Health Ministry’s AIDS budget (http://www.worldbank.org/aids-econ/thaifund.htm). By Thai standards this is very substantial sum; by comparison the budget of the entire Thai FDA was only about three times larger at that time. Because of dependence on government handouts none of Thai AIDS NGOs have an opinion that is at difference with the government policy. This lack of independence is demonstrated by their repeated attacks on V1, often in concert with Thai FDA (Bangkok Post 04.27.03). Arresting those who do not align with the government’s view has implications far beyond trivial issue of whether patients have the constitutional right to a treatment that has been scientifically proven to be safe and effective. Our company never claimed or advertised V1 as AIDS cure (Bangkok Post 02.03.02).

Thus, there is a clear conflict of interest between V-1 Immunitor supporters and Thai health authorities backed by Thai AIDS NGO’s. It is unfortunate that so far Bangkok Post mostly presented only one-sided opinion on V1 and we believe that for the sake of fairness you may consider our side of the story.

Mr. Vichai Jirathitikal, Pharm. Sci.
Chairman
Immunitor Corporation, Co., Ltd.

FDA confirms V-1 pill sales not legal - Bangkok Post, January 19, 2004
...The substance V-1 Immunitor cannot be distributed or sold because it is not registered as an Aids drug or a food supplement, the Food and Drug Administration says...
Magnesium chloride was named as the main ingredient in the licence application...
The licence of the Chachoengsao plant making V-1 Immunitor has been temporarily held back and a ban imposed on production...
In 2001, the product's backers distributed the product widely in Thailand, with the support of the Salang Bunnag Foundation, which later parted company with the manufacturers.

As we have mentioned before, we suspect that various legal measures will be used to silence all mention of V-1 so as not embarrass Thailand during the upcoming XV International AIDS Conference in Bangkok.

Four held for V-1 pill sales - Bangkok Post, January 18, 2004
Four people have been arrested after crime suppression police and health officials raided Ban Bangpakong, a clinic selling V-1 Immunitor pills for HIV/Aids patients... Mr Thares said Ban Bangpakong was not a typical clinic. He said it was called the Immunitor Support Society, which sought to help people with the disease...

V-1 press release: Immunitor publishes large clinical study in European Journal of Clinical Nutrition - January 7, 2004

V-1 floods into Swaziland - Firm denies exporting tablets - Bangkok Post, January 4, 2004
... The press reports identified the source of the "miracle drug" as Sutitangwe Medical Services, located in the Swazi capital of Mbabane, and owned by two Thai nationals and a Swazi.
They also mention 2Bangkok.com without actually mentioning this site: Thailand is to host the International Aids Conference in July. Dr Aldar recently told a Bangkok website Immunitor intends to try to take part, although "if rejected we have plans B and C".
This quote is from here in May 2003. The rest of the story was that there was some miscommunication--Dr. Aldar did not realize we were going to post his comments. However, after he saw them online he decided not to object.


Thailand company ready to manufacture AIDS drugs
- GNA, October 24, 2003
Immunitor Corporation, the company behind V-1, pointed out this article about V-1 being used Ghana: A Thailand-based organisation, Immunitor Corporation Company Limited on Friday expressed interest in transferring technology into Ghana for the production of an HIV/AIDS therapeutic drug to prolong the lives of patients. Dr. Aldar Bourinbaiar, the Scientific Director of the company, said the V-1 immunitor drug, already in the country, has been tested in clinical trials in 26 African countries with Ghana being the only African country to have registered it with the Food and Drugs Board.

Latest V-1 press release - October 11, 2003
Dr. Aldar S. Bourinbaiar, the Scientific Director of Immunitor, gave a presentation at the 6th International Forum on Global Vaccinology: Vaccines and Immunization in Belarus. We've put the entire press release in our V-1 forum.

Immunitor's presentation was praised by the Honorary Chairman of the Forum, Professor Veniamin I. Votyakov, a member of Belarusian and Russian Academy of Sciences, as an example of finding simple and inexpensive solution to global health crisis especially in countries that have no means to purchase often-expensive antiviral drugs or vaccines.
...Mr. Vichai Jirathitikal, who is a pharmacology graduate of Mahidol University in Bangkok and the principal developer of the vaccine. 'V1 is now registered in Ghana and we have pending licenses in several other African countries. We are currently discussing plans to build a vaccine plant in two of these countries as part of our long-term goal to provide affordable and safe therapy to the developing world".


Was V-1 ever claimed to be a cure for AIDS? - June 19, 2003
With the net's only webpage on V-1, 2Bangkok.com has been following the saga of this homegrown AIDS treatment in the leadup up to next year's XV International AIDS Conference in Bangkok. Genevieve M. Clavreul ("one of the original consultants hired to look at the efficacy" of V-1) has written a rebuttal to several recent claims by V-1 supporters, including the claim that V-1 was never touted as a Thai cure for AIDS.

Genevieve M. Clavreul writes: As I have stated once before in a previous email to you, I have been monitoring your page with interest. After having read the most recent posting, the response from Dr. Bourinbair, I would like to provide you with some feedback and additional background information.

Aldar refers to "they" having "once before in Durban we managed to get one abstract because back in 2000 they did not know about it". This statement is, I feel misleading. I submitted the abstract as a latebreaker to the Durban conference, and I was the primary presenter at the poster session. Also, as an experienced presenter of numerous conferences and meetings, I know from experience that even the most highly regarded and anticipated data can often be rejected and there is no more nefarious reason than some thing as simply as lack of space. However, I do find Aldar's reference to this presentation of interest, since in the other published works, I do not think it has ever been referenced.

As to Aldar contentions that Dr. Vichai has not referred to V-1 as a cure, I would have to disagree with this statement. I have personally been present with both Dr. Vichai and Mr. Jira have made such claims and when I have been present when they made these claims I have admonished them not to refer to V-1 as a cure. Do not hesitate to contact me should you have any questions.

V-1 proponents speak - May 13, 2003
Dr Aldar Bourinbaiar responds to 2Bangkok.com concerning the latest V-1 developments. Immunitor does intend to submit papers to the XV International AIDS Conference to be held in Bangkok in 2004 (Of course we will submit abstracts to Bangkok event and depending on political climate (which does not look favorable at this time point, especially here in Thailand)...)
Dr. Bourinbaiar also states that V-1 has never been claimed as a cure for AIDS, just that in some patients it can cause the virus to be "no longer detectable in their blood." Also that the FDA license for V-1 has not been canceled as was reported in the Post and they have included a letter to the editor of the Bangkok Post which was never printed in the Post, but we have posted in full below.
Dr Aldar Bourinbaiar responds
: We have submitted 4 abstracts to the last AIDS conference in Barcelona - they were all rejected "due to lack of space". Once before in Durban we managed to get one abstract because back in 2000 they did not know about it. We still managed to attend the Barcelona event and present at some satellite meetings, mostly those that dealt with inexpensive therapies for third world countries (see for example http://www.iaen.org/files.cgi/7014_Bourinbaiar.pdf).
Of course we will submit abstracts to Bangkok event and depending on political climate (which does not look favorable at this time point, especially here in Thailand) we will be there. In case it rejected we have plans B and C. Considering the overwhelming support we have in other countries it can be a memorable event. Besides, contrary to incorrect report in Bangkok Post our license is not cancelled. We send them a correction letter but it was not published (see below).

Immunitor Statement (letter to the editor of the Bangkok Post from Immunitor Company)

As announced in media reports Immunitor Company has received a letter from FDA officials indicating that they intend to cancel food supplement license for V1, V2, V3, and V4 products manufactured by the company. The content of this letter is interpreted by our legal advisors, one of whom is former Minister of Health, as an intent letter not the actual cancellation letter. The letter gives us 15 days to reply to this action. The reasons given by the FDA for cancellation were as follows: the investigative committee set up by the Ministry of Health found out that (1) products were manufactured by a factory that has no license; (2) alleged advertisement of V1 as a "cure for AIDS" in Bangkok Today newspaper on March 6, 2003, and (3) V1 is ineffective and has no clinical benefit.

The original manufacturing license for V1, V2, V3, and V4 was issued to Jirasathaporn Company - a company which is now registered as Immunitor Company as affirmed by the Ministry of Commerce on September 23, 2002. The products are currently being manufactured at a factory in Bangpakong Industrial Park, Chachoengsao province. The good manufacturing practice (GMP) license for this factory has been applied and the FDA inspection team visited our factory and found it to be suitable for manufacturing V products. The factory’s layout blueprint has been approved and GMP license is now pending. Immunitor has an approval letter from the FDA indicating that GMP license will be issued shortly.

The Immunitor did not place any advertisement in Bangkok Today newspaper at any time. The alleged advertisement is an interview that was conducted by a reporter from this paper. The final printed story is false and does not reflect the viewpoint of Mr. Vichai Jirathitikal. His official point of view on whether V1 is a "cure" for AIDS is published in the interview to the English language Nation newspaper on Oct 3, 2002 (http://www.nationmultimedia.com/page.arcview.php3?clid=12&id=66767&usrsess=1) and has been also addressed earlier in Bangkok Post on March 2, 2002. The relevant section related to "cure" issue is as follows: "I have never claimed that V1 is a cure. Our viewpoint on whether V1 is a cure can be found in the Q&A chapter of the book "V-1 Immunitor: Grass-roots Aids initiative in Thailand" published in 2001 by Thammasat University. We cite in its entirety the appropriate passage. Q: Will V1 cure Aids? A: We don't know yet whether V1 will cure Aids. Blood tests of some patients have shown that the virus is no longer detectable in their blood, but we need to do more studies to confirm this observation. We are scientists and we do know the fine distinction between the terms "cure" and "treatment". In the Thai language there is no distinction between these two terms (raksa) and many in the local and even international media failed to understand the implications of the difference of Thai term translated into English."

Immunitor also states that clinical studies of V1 showing the benefit to AIDS patients have been published in several peer-reviewed international medical journals, including HIV Clinical Trials, Vaccine, Electronic Journal of Biotechnology, etc. The clinical findings of V1 were presented at many international and domestic scientific conferences during last 2 years. The investigative committee set up by the FDA has never requested from Immunitor to review these reports and thus Mr. Vichai Jirathitikal, is unaware on what basis they were able to conclude that V1 is ineffective. Concerning V2, V3 and V4 products: they are unrelated to V1 and intent of canceling their licenses is without any base.

The apparent conduct of FDA does not fit the promotion and support of the local Thai industry as advocated by the government of Thaksin Shinawatra. V1 is vital to the fight against AIDS epidemic not only Thailand but in the whole world. Today, V1 has been used by 65,000 patients in 60 countries, including 23 countries in Africa. Due to popularity of V1 the Immunitor Company has pending regulatory licenses in countries other than Thailand and is planning to manufacture V1 outside of Thailand in near future.

Immunitor will appeal the FDA letter and is confident that the justice will prevail for the sake of lives of thousands of AIDS patients around the world. For further information please contact [email protected]

"Pill of hope for HIV+ people" - May 11, 2003
Hopes the authorities had that the extravagant claims of the V-1, the Thai "cure" for AIDS, would go away before the XV International AIDS Conference (to be held in Bangkok in 2004) are dashed by a series of articles in a Malaysian paper as V-1 proponents take their claims international. Among other things, the article claims a government conspiracy in which a supporter of V-1 was murdered.

Pill of hope for HIV+ people - The Star, May 5, 2003
Sirpai Poontawee and her eight-year-old daughter Priyanod Muangthai at the V1 Immunitor clinic in Bangpakong. Having taken V1 pills for two years now, mother and daughter are now a picture of health. And their progress was tremendous. After a few months and even just weeks of taking the drug licensed as a food supplement in Thailand, patients were getting better. Skin lesions healed and scabbed over. Those with full-blown AIDS symptoms recovered and felt strong enough to go back to work. Even some bedridden patients on the verge of death got up and started walking...
...The free distributions had the patronage of the Salang Bunnag Foundation, which is headed by a controversial figure in Thai politics. Police General Salang’s involvement with V1 turned AIDS activists and the foreign press against V1. He was remembered as the man who commanded the police and paramilitary in the Thammasat University massacre of pro-democracy supporters in 1987. In 1996, he ordered the execution of six drug dealers in his custody, which was caught on film...
...“We are seeing an 85% efficacy rate. That has never been seen in any AIDS drug or vaccine,” (Dr Aldar Bourinbaiar) said.
...(An anonymous doctor who supports V1) blamed the resistance to accepting V1 on the chauvinism in mainstream science that is Western-based. It locks the mind into a certain way of thinking, he asserted.


Unwelcome treatment for V1 - The Star, May 5, 2003
...V1 maker Vitchai Jirathitikal said V1 has never claimed that it was a cure for AIDS, or put out an advertisement to promote V1. “There is a fine distinction between ‘cure’ and ‘treatment’ but in the Thai language there is none. We have always said that more research is needed but what we have found is that blood tests of some patients have shown that the virus is no longer detectable in the blood,” he said.
Also How V1 works - The Star, May 5, 2003

V-1 license revoked - Bangkok Post, April 24, 2003
The National Food Commission has decided to revoke the manufacturing and sales licences for the controversial food supplements V-1, V-2, V-3 and V-4 Immunitors, saying they were sub-standard products whose effectiveness as a cure for HIV/Aids had been exaggerated. Food and Drug Administration secretary-general Supachai Khunaratanaphruk said after a meeting of the commission yesterday the manufacturer continued to insist its products could cure Aids, though they were registered only as food supplements...
Immunitor ban backed by NGOs - Bangkok Post, April 27, 2003

Claims of V-1 success against hepatitis - April 19, 2003
The promoters of V-1 have a study published in The Electronic Journal of Biotechnology suggesting "that V1-exposed patients may have been immunized against" hepatitis ("April 15, 2003 issue of peer-reviewed, UNESCO/MIRGEN-sponsored online publication Electronic Journal of Biotechnology based in Chile").

Verifying V-1 studies - March 11, 2003
A local researcher is claiming that papers on the "Thai cure for AIDS" appeared in peer-reviewed journals ("Orapun Metadilogkul, also the president of the Occupational and Environmental Medicine Association of Thailand, said her studies were reliable and published in two international medical journals _ HIV Clinical Trials 2002 of Thomas Land Publishers and Elsevier Vaccine Journal of Elsevier Science Ltd."). Since earlier references to V-1 studies in the local press turned out to be completely false, 2bangkok.com asked the journals in question if they could confirm they carried the studies.
Ken Killion of Thomas Land responds: ...There was a brief paper in HIV Clinical Trials 3:1 (January/February 2002) and abstracts are available at www.thomasland.com. The conclusion made by the authors was that V-1 deserved further evaluation in placebo controlled trials.
The study: "CONCLUSION: Mucosal delivery of HIV antigens provides compelling results and deserves further evaluation in placebo-controlled clinical trials. "

The other study was in Vaccine (Elsevier Science): V-1 Immunitor: oral therapeutic AIDS vaccine with prophylactic potential , Volume 21, Issues 7-8 , 30 January 2003, Pages 624-628
"V1 does not appear to induce HIV-specific antibodies as orally administered immunogens usually produce cell-mediated but not systemic humoral response. V1 as a preventive oral vaccine targeting cellular and mucosal immunity deserves further evaluation."
Meanwhile, every other day or so, the Bangkok Post carries ads (right) requesting sales agents for V-1.

Advocate adamant V-1 study legitimate - Bangkok Post, March 6, 2003
...One said the blood of 22 HIV sufferers who had taken V-1 immunitor for a year became HIV negative...
Earlier: Ministry wants to counter V-1 Aids-cure publicity - Bangkok Post, February 28, 2003
In July, 2004 the XV International AIDS Conference will be held in Bangkok. It's certain the government would like V-1 to be a distant memory by then so as to avoid the embarrassing publicity that AIDS-denying South Africa received when it hosted the conference. However, V-1 has some shadowy influential backers.

V-1 ad - January 2, 2003
Thanks to Don for pointing out this ad that appeared in Matichon newspaper on January 2, 2002 for the Thai "cure" for AIDS, V-1 Immunitor.



V-1 in the Boston Globe - December 8, 2002
V-1 has become a political hot potato, so much so that the head of Thailand's FDA recently ordered government employees not to speak about the pill to the news media. Officials from the FDA, Ministry of Health, and Medical Sciences Department all refused to comment for this story.
Further alarming health officials, V-1 has shown up in China, parts of Africa, and even in small numbers in Europe and the United States. How is not clear, although Bourinbaiar said HIV-positive tourists buy it in Thailand and take it home.
The secrecy in which the ingredients of V-1 are cloaked also breeds skepticism, since secrecy is a characteristic of quack remedies, exempting them from scientific study. Jirathitikal said it contains ''inactivated HIV antigens,'' but will give no further description
.

Business Day article disappears - December 20, 2002
Several weeks ago, 2B exposed erroneous info from Business Day about V-1 (the Thai 'cure' for AIDS). We challenged Business Day to print a retraction or explain the source of their information. Instead, the archived copy of the article vanished from their website without comment. Lucky we saved a copy (below). There is pretty much a consensus in the press that making press errors vanish online is unethical. The accepted practice is to openly correct the errors with a retraction just like one would in a printed edition.

Below is the article removed from the Business Day website (formerly at this address http://bday.net/bdetail.asp?id=4086):

Researchers show V-1 Immunitor is good news for HIV patients

Business Day Editorial

Recently, the world's famous HIV research institute, Aventis Pasteur, has raised the Thai food supplement V-1 Immunitor to Phase 3/4, a stage that indicates it has shown to be the most effective cure against Aids so far. The Thai HIV product has successfully undergone Phase 3 safety and immunogenicity tests. It still needs to go through Phase 4 - the final phase that proves its real effectiveness.

This is certainly a good news for the V-1 Immunitor inventor, Pharmacist Vichai Jirathitikarn, and thousands of HIV patients all over the country who are taking the drug (currently considered by the Thai Food and Drug Administration as a mere food supplement). However this good news has not been well recognized by the Thai Public Health Ministry and other medical authorities.

Public Health Minister Sudarat Keyuraphan said last week the ministry declined to include the V-1 Immunitor (under the medical name "Absorbed Inactivated virion") in the government's 30-baht universal health care coverage scheme. She said the ministry would reconsider only if and when V-1 could be scientifically proved as a valid medicine.

The V-1 Immunitor made its debut last year when Pharmacist Vichai and a former police deputy chief, Pol. Gen Salang Bunnag, started distributing the V-1 Immunitor free of charge to interested HIV patients. Vichai developed the V-1 Immunitor at his Ban Bangpakong Clinic in Chasoengsao province, 80 kilometers east of Bangkok.

More patients kept coming to receive the drug after learning that many HIV patients taking V-1 Immunitor have gained better health, with their HIV status turning from positive to negative.

Unfortunately, four months ago doctors volunteering at the Salang Bunnag Foundation accused Vichai of breaching an agreement that it be distributed free of charge, and that the substance had failed to improve immunity levels.

To these charges, Vichai replied that his clinic would not survive if it continued to distribute the product free of charge. He also said that people who took V-1 should stay under close supervision by doctors - another reason why indiscriminate giveaways would not work. He did admit that some patients who took V-1 had grown worse and died, but said they all had had very low immunity levels which were hard to reverse.

Vichai also pointed out that vested interests would stand to lose if V-1 was a success. These vested interests include drug firms distributing anti-antroviral drugs costing 20,000 -30,000 baht a month. That's why poor HIV patients died quickly - they could not afford to buy such expensive medicines.

Vichai's Ban Bangpakong Clinic sell V-1 at 60 baht per tablet to people who can afford to pay, but support patients who cannot.

Apart from his patients who recovered from the HIV status, numerous doctors have also supported him after their own individual studies of different groups of HIV-infected patients taking V-1 Immunitor.

Oraphan Methadilokkul, an expert in occupational and environmental medicine at Rajavithi Hospital, recently cited her finding from a 14-month follow-up study of 22 patients whose blood tests were reported to have turn negative after they took V-1 from Ban Bangpakong Clinic. She said it was still too soon to conclude that the food supplement was an effective cure against HIV/Aids, and more studies were needed.

With the recent listing of V-1 Immunitor by Adventis Pastuer as the highest potential for curing this terrible disease, the Thai Public Health Ministry and/or medical institutes should support extended researches on this food supplement, for the sake of not only the Thai patients, but also the HIV/Aids sufferers worldwide.

Bogus Business Day editorial - November 28, 2002
On November 19, 2002, a Business Day editorial reported "the world's famous HIV research institute, Aventis Pasteur, has raised the Thai food supplement V-1 Immunitor to Phase 3/4, a stage that indicates it has shown to be the most effective cure against Aids so far" (Researchers show V-1 Immunitor is good news for HIV patients - Business Day, November 19, 2002). It sounds absurd right off. The editorial went on to claim that drug companies do not want V-1 to be a success because they would lose money and ended with a plea for the Public Health ministry to support V-1 research, etc.
So, 2Bangkok.com wrote Aventis Pastuer to see if the Business Day claims were true. Here is Aventis Pastuer's reply:

Dear Sir,
Thank you for contacting us.
In response to your question, Aventis Pasteur is not involved in any way with V-1 Immunitor or the company that makes it. It has neither reviewed nor approved V-1 Immunitor and as such has no opinion on the product. Aventis Pasteur is entirely devoted to vaccine development; we do not therefore intend to either review or approve this product in the future as it is not consistent with our scientific focus.
Sincerely,
Koren Wolman-Tardy
Corporate Media Relations
Aventis Pasteur
2, avenue du Pont Pasteur
69367 Lyon cedex 07
France
tel: (33) 4 37 37 72 73
fax: (33) 4 37 37 79 76

We've asked Business Day to print a retraction... We also wonder where they are getting their information. There seem to be many V-1 sympathizers in the local Thai press. It is a compelling dream that someone in a third world country could 'invent' a cure or treatment for AIDS so sufferers would not have to rely on overseas drug companies.

The Nation's "interview" about V-1 - October 3, 2002
The Nation printed what they claim is an interview with the inventor of the V-1 drug, but a simple net search shows chunks of the article are merely adapted from a press release from the Salang Bunnag Foundation from August 15, 2001. The V-1 frenzy has recently unraveled: doctors who once helped distribute the drug now disavow it, the clinic that distributed the drug was ordered closed, and the foundation that once touted it now claims they were tricked into distributing it.

More on Thailand's "AIDS cure" - Bangkok Post, August 29, 2002

V-1 - the evil that men do - 08:10, July 14, 2002
Did you know there's a cure for AIDS in Thailand? ...Thailand risks becoming a dumping ground for treatments that have not passed strict tests elsewhere. Desperate HIV carriers unable to afford approved treatments could be lured to try fraudulent or unsafe drugs. "There is a lot of money to be made by evil people through this disease," he said. BTW: The XV International AIDS Conference will be held in Bangkok in July, 2004.


V-1 Immunitor tablets
- February 16, 2002
There's always wishful thinking that smaller nations should be able to go into their forests and find traditional cures for ailments that would forestall having to buy expensive foreign drugs. Last year, thousands were taken in by a health clinic's claim of a locally produced cure for AIDS. Now, better late than never, some payback: The Public Health Ministry will initiate legal proceedings against Ban Bang Pakong clinic in Chachoengsao for misleading the public with advertisements that seemed to suggest that HIV-positive people had become HIV-negative after treatment with controversial V1-Immunitor tablets, the Medical Council said yesterday.... Chumsak said the Medical Council would announce tomorrow the outcome of its study on the effectiveness of V1-Immunitor tablets, which it has been studying since last year. "The study reveals that the products have no effect on HIV/Aids," he said. (Clinic to be sued for ad, The Nation, Feb 13, 2002 )

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One Response to V1 Immunitor

  1. Anonymous says:

    Groundbreaking immunotherapy trial in advanced liver cancer
    VANCOUVER, British Columbia, April 13, 2017 — Immunitor Inc., is pleased to report publication of a first ever successful trial in the oncoimmunology field showing that the once-daily tablet of oral immunotherapeutic vaccine, hepcortespenlisimut-L (Hepko-V5), was safe and highly effective in treating patients with advanced liver cancer – inoperable hepatocellular carcinoma (HCC). The open-label Phase II study conducted in 75 patients with late-stage HCC appeared in open access Journal of Hepatocellular Carcinoma (https://www.dovepress.com/articles.php?article_id=32377).
    The overall survival observed in the published study was outstanding – over 90% of patients were alive after median 12 months of follow up – by comparison only about 10% survive after one year of treatment with sorafenib. This study has also shown that after median 2 months of treatment 50 out 75 patients had their hepatic tumor marker, alpha-fetoprotein or AFP, declined, which indicates that two thirds (66.7%) of studied population responded to immunotherapy, since the decrease in AFP was correlated with tumor shrinkage. Those who had AFP down to normal levels experienced tumor clearance, implying that they were cured. There were 12 patients (16%) in the study who ended up with normalized AFP below 10 IU/ml. No adverse events or toxicity were observed at any time – an observation in line with the experience in over 10,000 people who took V5 for the past 15 years in more than 30 countries for clinical indications such as liver cirrhosis and hepatitis. Considering that no validated immunotherapy for liver cancer has emerged after 20 years of research efforts, these results are highly promising. An ongoing Phase III study at the Mongolian National Cancer Center is aimed to confirm the potential of hepcortespenlisimut-L in placebo-controlled, randomized setting.
    HCC is the second most common cause of death from cancer, estimated to be responsible for 788,000 deaths or 9.1% of total cancer fatalities in 2015. Aside from surgery, the only available option is the FDA-approved chemotherapy, sorafenib (NEXAVAR), which prolongs life by 2.8 months, results in 2% of partial clinical response, but no cure. According to the American Cancer Society 40,710 new cases of HCC and intrahepatic bile duct cancer will be diagnosed in 2017 in the United States. “While HCC rates have tripled since 1980, they are still relatively low in North America and most of Europe, but it is a major cause of death in developing countries”, said Dr. Allen Bain – director of Vancouver-based Immunitor Inc. “Half of liver cancer patients are in mainland China”, added Mr. Alan Reid – head of Hong Kong-registered Immunitor China Ltd – a company set up to address the unmet need of Asian market. “Africa has the remaining share of burden”, joined Mr. Paul Heslop – the company manager in Johannesburg, South Africa. Mr. Valeryi Kalashnikov – representative in Moscow, Russia – noted: “Eastern Europe and Russian Federation are additional target countries with high prevalence of hepatitis, cirrhosis and liver cancer”. Dr. Aldar Bourinbaiar, CEO of Mongolia-based Immunitor LLC, commented: “The results of this trial are good news to patients with HCC, who now have life-saving option. We are deeply satisfied by outcome of this study, which has all the signs of long-awaited breakthrough in liver cancer. This trial is yet another proof-of-concept for our oral vaccines platform designed to counteract cancer-associated inflammation through induction of immune tolerance, explaining why our vaccine can cure cancer, but without any evidence of toxicity”. The co-founder of the company, Mr. Vichai Jirathitikal, concluded: “Hepko can control HCC the same way as V5 has shown for hepatitis and cirrhosis”.
    About Immunitor
    Immunitor Inc. is a privately held, commercial stage biopharmaceutical company with headquarters in Vancouver, Canada (www.immunitor.com) and offices in Beijing, Johannesburg, Moscow and Ulaanbaatar. Immunitor’s strength resides in its proprietary oral vaccine platform validated by numerous clinical trials conducted over the past 15 years. Immunitor makes several immunotherapy products addressing major health problems, i.e., in infectious diseases area: HIV, HBV, HCV, influenza, malaria, fungal and microbial infections including tuberculosis; in the area of autoimmune and metabolic diseases: i.e., renal failure, thyroiditis, Alzheimer disease, hypertension, atherosclerosis, obesity and diabetes; and recently in oncology space, with several candidates currently being investigated. The immediate goal of Immunitor is to address the unmet need in a wide range of liver-related diseases. A Phase II trial in patients with cholangiocarcinoma – second most common form of liver cancer affecting bile ducts – has been initiated last month. Soon, another immunotherapy will be deployed with intent to treat pancreatic cancer, which has the worst prognosis out of all forms of cancer. Based on encouraging preliminary data in HCC patients, hepcortespenlisimut-L has received orphan drug designation from the U.S. Food and Drug Administration (FDA), which clears the path toward approval in US market.

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