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IMMUNATOR |
By Aldar S. Bourinbaiar
Immunitor to collaborate with Russian biotech giant Vector
Bangkok, November 17, 2003 -- Privately held, Thai-US vaccine company, Immunitor Corporation, exchanged letters of intent with VECTOR &endash; the State Research Center of Virology and Biotechnology, Russian Federation Ministry of Health, Koltsovo, Novosibirsk region, Russia.
Both parties have expressed interest in joint development of orally delivered vaccines for a variety of viral diseases. This initiative originates from ongoing collaboration between Russian and Thai scientists in developing the new generation of smallpox vaccines as part of the international effort against bioterrorism. In addition to these goals other infectious diseases of concern to the public health will be investigated. The immediate targets of particular interest to both companies are HIV/AIDS, malaria, TB, and SARS. Vector has recently developed a laboratory diagnostic kit for SARS, which was based on the public database of coronaviruses' genome sequences and will be capable to rapidly expand virus production on a commercial scale to satisfy needs for inactivated vaccine manufacture. Pursuant to the aims of letters of intent the plan for setting up a vaccine plant in Siberia is currently being discussed as the possible logical outcome of this partnership.
Russian government's State Research Center of Virology and Biotechnology VECTOR also known as Vector was established in 1974 (www.vector.nsc.ru). Vector has been pursuing various basic and applied research activities aimed at the development and manufacture of novel therapeutic, diagnostic, and vaccinal preparations against virus diseases. Professor Lev S. Sandakhchiev, the Director General of Vector, noted that 'Considering the synergistic interest in this area and ongoing collaboration between Vector and Immunitor researchers this project will have significant impact on the future of vaccine industry and global health crisis. We have been working on mucosal immunization approach ourselves and the technology developed by Immunitor is promising as simple but effective means of vaccine delivery'.
Immunitor Corporation is the first private, biotech company formed in Thailand. As opposed to standard injectable vaccines, inactivated or 'killed' oral vaccines developed by Immunitor have distinct advantages: (1) unparalleled safety and efficacy; (2) simplicity of administration; (3) unprecedented stability and long shelf-life without need for refrigerated storage; (4) no need for syringes and no risk of being infected with contaminated needles; (5) no specially trained medical personnel to carry on vaccination campaigns; and (6) large quantities of desired vaccine can be manufactured at low cost. Mr. Vichai Jirathitikal, the Chairman of Immunitor, said on this occasion 'I am very excited to have Vector as our partner. Vector's expertise in recombinant vaccine technology and in-depth knowledge of biodefense-related projects is a tremendous asset to our company. Together, we can develop affordable and safe vaccines against major infectious diseases that plague developing countries such as in Africa and Asia. I am looking forward to long-lasting, mutually beneficial relationship'.
UNESCO/MIRGEN-sponsored online publication Electronic Journal of Biotechnology based in Chile (see full content of the paper at: www.ejbiotechnology.info/content/ vol6/issue1/full/3/reprint.html). This work was a joint research effort with clinical team of Dr. Orapun Metadilogkul of Rajavithi Public Hospital in Bangkok, Thailand. The preliminary results of this study were presented earlier at the international symposium Therapies for Viral Hepatitis held in Boston on October 29-31, 2002
(http://www.intmedpress.com/pdfs/Sessions3-4.pdf)
Chronic liver infection with hepatitis B and C viruses are life-threatening diseases. Available hepatitis drugs can only produce a transient remission of the disease, which re-emerges after therapy cessation. No effective therapeutic vaccine is yet available. V-1 Immunitor (V1) is an oral therapeutic AIDS vaccine developed by the Immunitor Corporation and is licensed in Thailand as a food supplement. V1 comprises heat-inactivated HIV antigens from pooled clinical isolates derived from the blood of HIV-infected donors.
The vaccine also comprises antigens from HIV-unrelated systemic pathogens commonly found in AIDS patients. Due to frequent incidence of hepatitis B and C among HIV-infected donors it has been hypothesized that V1 may be also effective against hepatitis. Indeed, in this published open label trial 95% patients who entered the study with elevated enzyme levels became indistinguishable from normal individuals as assessed by liver transaminases, bilirubin and alkaline phosphatase levels. In addition, three patients who were hepatitis B surface antigen positive at study entry became negative after V1 treatment. The favorable clinical response suggests that V1-exposed patients may have been immunized against HBV.
Some rare forms of hepatitis are recognized as being bona fide autoimmune and are usually responsive to immunosuppressive drugs, e.g., Cyclosporine A. However, the notion that chronic hepatitis is an autoimmune disease has not been very popular despite the overwhelming evidence that cell-mediated immunity contributes to self-directed liver cell injury. Thus, from the immunological point of view chronic viral hepatitis can be considered as an autoimmune disease. As opposed to parenteral route, the administration of immunogens by oral route is generally believed to induce the tolerance. If a vaccine is administered by injection it will activate the immune system and may thus exacerbate the symptoms of the disease. Individuals with natural tolerance to hepatitis virus have minimal or no liver injury despite chronic viremia. It is known oral feeding of immunogens can induce immune tolerance and improvement of the clinical picture. Thus, orally administered V1 was expected to produce tolerizing effect rather than stimulating effect. The possibility that this approach may work is supported by this published study and by yet to be published independent clinical studies in Israel carried out by Professor Yaron Ilan at Hebrew University-Hadassah Medical School. Principles governing the mucosal response and/or tolerance are still unknown and the analysis of the immune status in subjects receiving oral V1 may provide an answer.
For further inquiries please contact the Company at info@immunitor.com.
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Immunitor publishes article on affordable AIDS drugs
Immunitor Corporation &endash; Thai biotech company- announces publication of 'Low-cost anti-HIV compounds: Potential application for AIDS therapy in developing countries' in Current Pharmaceutical Design (Vol. 9(18): pp. 1419-1431, 2003). The abstract of the paper can be found on the PubMed website of the National Library of Medicine (http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12769722&dopt=Abstract ). The essential elements of this paper were first presented last year at IAEN symposium: 'Economics of HIV/AIDS in Developing Countries', which was held during 14th International AIDS conference in Barcelona, in July 2002 (www.iaen.org/files.cgi/7014_Bourinbaiar.pdf). IAEN or International AIDS Economics Network is a multinational NGO which focuses on affordable HIV/AIDS prevention and treatment, by providing data, tools, and analysis for researchers and policymakers working to define and implement cost-effective AIDS policy.
Considerable progress has been made in recent years in the field of drug development against HIV. However, the current cost of AIDS drugs is the main obstacle that prevents their use in developing countries, where 98% of HIV-infected patients reside. The average yearly price of AIDS therapy and related health care of affected patients in industrialized countries runs as high as $22,000 &endash; an amount that corresponds to the combined income of as many as one hundred individuals in developing countries. Even in these countries, patients without medical insurance cannot afford the costly therapy. From the beginning it was clear that the most feasible and economic means of reaching this goal is to identify anti-HIV drugs among already available and preferably over-the-counter pharmaceuticals, which have historically been used for unrelated clinical purposes. Immunitor's paper summarizes its own original research relating to development and discovery of affordable and potentially promising AIDS drugs. The anti-HIV activity of drugs and immunomodulating substances such as warfarin, cimetidine, levamisole, acetaminophen, gramicidin, and V-1 Immunitor (an oral AIDS vaccine also known as V1) are described and discussed in relation to their clinical application.
President of Immunitor, pharmacologist Vichai Jirathitikal, noted that '…the publication of this landmark paper coincides with the 2nd anniversary of the public launch of V1 in Thailand. The first mass-distribution took place on June 2, 2001 at Thai-Japan stadium in Bangkok. On that historic day we gave V1 to 4,000 people. During summer and fall of 2001 we have treated free-of-charge 40,000 AIDS patients. Today, over 65,000 patients in more than 60 countries, including 26 countries in Africa, have benefited from our relentless effort. We have been and still are facing the resistance to our work. It is difficult to be a pioneer in this highly competitive field especially if you are from the third world country. Nevertheless despite difficulties and lack of public funds we were able to publish our clinical data in several peer-reviewed international journals and this publication is another proof that a small company like ours can make the difference on global AIDS crisis.' For further information and reprints request please write: info@immunitor.com
THEY came looking for straws to clutch. Emaciated and weakened, many with skin lesions and bodies infected with fungus, some carried on a stretcher, they came bearing the marks of the assault of a disease that had claimed over 28 million lives since the beginning of the epidemic two decades ago.
With their immune systems gradually wrecked by the Human Immunodeficiency Virus (HIV), their bodies are exposed to an array of opportunistic infections and a simple case of flu becomes a matter of life and death. In scores, they came to the Bangpakong clinic located in Chachoengsao province in the outskirts of Bangkok to obtain the V1 Immunitor, an oral vaccine, touted to be the first of its kind in the 20-year war against the AIDS epidemic.
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.
I went to Bangkok to see for myself people living with AIDS who have taken V1. I wanted to investigate if indeed the claims of the first effective AIDS vaccine were true or if the opponents of the controversial V1 were right &endash; that V1 was "useless" as the then Centre of Communicable Diseases director-general Dr Samsong Rakpao had said last year, or a scam as asserted by AIDS NGOs in Thailand.
I met Sirpai Poontavee, 31, from Prachinbun district and her eight-year-old daughter, at the V1 Immunitor clinic. They had come in a taxi to take their monthly supply of the oral vaccine. The clinic, across the road from the V1 manufacturing plant, is located in a bleak, sun-scorched industrial zone dotted with characterless white buildings.
The odour of burnt cocoa from a nearby chocolate factory wafted into the clinic as patients took turns standing on the weighing machine to have their weight charted and their medical histories recorded.
A mother of two, Sirpai discovered her HIV-positive status five years ago. A housewife then, she was infected by her husband who died two years ago. Speaking through a translator, she said she started having AIDS symptoms about the time when her husband died of AIDS.
Her two daughters were also infected but she was too poor to afford antiviral drugs, the standard treatment for AIDS.
"My health deteriorated. I felt feverish. I had oral thrush and fungal infections which caused red spots all over my legs. I became so thin and I looked like a sick person, sick with AIDS and I was ashamed to be seen. I felt like there was no future for us."
Sirpai started taking V1 pills two years ago after being told of V1 by her friends.
"My children used to have skin disease. They were weak and they were sick all the time. I worried for them. But now they have normal lives. They go to school like normal kids. Look at my skin now and the colour on my face. My friends don't even believe I have AIDS," said Sirpai, holding her eldest daughter, Priyanod Muangthai, 8. Both were a picture of health.
Sirpai continues to take one pill a day, and fed the same amount to both her children.
Another patient, Anan Ketnork, was near death when he took V1 and has resumed normal activities since. A wiry young man in his late 20s, Anan could not walk when he came to the V1 free distribution at the First Provincial Police Headquarters in Bangkok in 1999.
The event attracted broad media coverage. Showing symptoms of full-blown AIDS, Anan was dazed and disoriented when he was wheeled into the police station that day. Images of his emaciated frame slumped on the wheel chair were splashed in the newspapers and aired on prime time news the following day.
"I was told by the doctor that I had fungus in my brain. I took herbal medications and after that I couldn't eat or swallow or get up and I had this constant terrible headache. I also lost a lot of weight. I felt like I was dying," he said.
Anan, who used to work in a furniture factory, said he was infected by his wife who had received several blood transfusions as a result of massive blood loss from a miscarriage she had in 1998. Although infected earlier than Anan, his wife had not shown AIDS
symptoms so the responsibility of caring for the family fell on her.
Vitchai Jirathitikal (right) with a patient at the Bangkapong V1 clinic. Vitchai: "The goal is to find a medicine that does not give
bad side effects. How can you fight the virus when you are sick?"
"I was never unfaithful to my wife so we think it was the blood transfusion. At the time when I was sick, my wife was earning 90
baht (about RM9) a day shelling oysters. She had to borrow money to pay for my medication and support the family," he recounted.
Anan said he was given 14 free tablets and after taking them for a mere one week, he started to regain his strength. He was able to sit up unassisted, feed himself and his appetite returned, he said. He continued taking them and was able to do light work around the house after two months.
"I still could not ride my motorbike or run, but I gained 11kg, from 41kg to 52kg. My headaches stopped. I am still taking V1 and I can work like a normal healthy person. I ride my motorcycle now to pick up the tablets from Chonburi," he said.
Sirpai and Anan are among thousands of people who have benefited from the vaccine developed by home-grown Thai pharmacologist Vitchai Jirathitikal, a graduate of Mahidol University.
The second son of a family of pharmacist, Vitchai had gone against his father's wish to work on HIV, joining scientists throughout the world in the race to find a cure for the AIDS epidemic.
Working in his family's lab at Bangpakong, Vitchai developed the V1, V2, V3, and V4 for different ailments by using a "new technology" that involves crystallising heat-inactivated antigens (viral, bacterial or fungal) in magnesium chloride, and packaging it in a pill coat that resisted the stomach's digestive action.
"The goal is to find a medicine that does not give bad side effects. Other drugs that have been developed to fight AIDS cause damage to the liver, heart and the kidneys. It weakens the immune system and the patients look even sicker. How can you fight the virus when you are sick?"
Vitchai said V1 had been tested for acute toxicity in mice and it was found that only if a dose equivalent to 2kg of V1, or 2,200 pills a day, was taken by a 70kg human could V1 result in harm. Even ordinary table salt can cause harm if 2kg of salt is consumed in a day, he said.
Other than having minimal side effects, he pointed out that V1 is affordable and its administration simple &endash; just pop the pill &endash; compared to conventional vaccine, which has to be injected.
But he insisted that he never claimed V1 was a cure for AIDS. "I am not saying V1 is a miracle drug. What it does is to boost the immune system to fight the virus. It is giving hope to people."
A grim reality
In Thailand, with one million people infected by the virus (one in 60 people in a nation of 63.6 million) and close to 300,000 killed by the disease, managing AIDS is a grim reality.
Last year, with some 29,000 new infections, AIDS has become the leading cause of death. However, only 5% of the one million infected people had access to antiretroviral drugs which cost between 10,000 baht and 30,000 baht (RM1,000 and RM3,000) a month.
This in contrast to a month's supply of V1 pills which costs 900 baht (RM90), far lower then even generic antivirals, which are sold at a subsidised rate by the Government Pharmaceutical Organisation of Thailand at 1,800 baht (RM180), a price still beyond the reach of most people living with HIV/AIDS in Thailand.
Currently, the Thai government provides subsidised antiretroviral treatment for 10,000 patients. But with a whopping 9.2bil baht (RM920mil) aid from the Global Fund for AIDS, Tuberculosis and Malaria approved this year, the Public Health Ministry announced that free medical aid would be extended to cover all those living with AIDS by 2007.
Even then, with the infection rate of 29,000 new cases a year and 55,000 AIDS-related deaths last year, the scenario on the ground is still bleak. Antiretroviral drugs have high toxicity, causing severe side-effects, and patients invariably develop resistance to it after two years. As a routine, hospitals send patients with terminal, full-blown AIDS to Buddhist temples to die.
Hope amidst controversy
When the V1 pill caught the attention of the media in 2001, it received mixed reactions from various quarters. The free distribution campaign to promote V1 was viewed with suspicion by AIDS organisations and public health officials. They had accused the promoters of V1 of raising false hope and regarded the free distribution as a publicity stunt on an unproven drug which only had a food supplement permit.
Shortly after the distribution campaign, including large stadium handouts in Bangkok, the V1, which had earlier received its food supplement permit on Oct 15, 1999, from the Thai Food Drug Administration (FDA), was deregistered on June 5, 2001.
But patients who have been taking V1 came out in full force in a demonstration to demand for the permit to be reinstated. A week later, the permit was reissued.
A day before the permit was reissued on July 13, 2001, the Bangkok Post reported that Prime Minister Thaksin Shinawatra gave his full backing for research on V1 pills.
Thaksin was quoted to have said that some officials were adhering too closely to international rules that were preventing Thai researchers from experimenting with AIDS vaccines.
"We should give Thai people opportunities to develop a vaccine," he said.
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.
Although V1 manufacturers had cut off ties with Salang since 2001, the damage had been done. With the bad press and attacks by powerful NGOs, some high-level public health officials had joined the crowd in denouncing V1. They claimed that cases of patients getting better were mere anecdotal evidence.
Scientific evidence
Since then, V1 has undergone clinical trials and research into its safety and efficacy. Outside of Thailand, it is gradually gaining recognition in the scientific fraternity.
With publications in the Electronic Journal of Biotechnology, and peer-reviewed journals such as HIV Clinical Trials and Vaccine, a leading international journal in the field, the V1 has received attention from countries hardest hit by AIDS. Eleven countries in Africa are currently testing the V1, with 10 more countries having plans in the pipeline.
V1 Immunitor scientific director Dr Aldar Bourinbaiar said the results of V1's efficacy as a potential therapeutic and preventive vaccine far surpassed any drugs or vaccine that have been developed since HIV was discovered two decades ago.
Dr Bourinbaiar is one of the pioneer researchers in AIDS drug and immunology and has a total of over 20 years of experience in patenting work and working in multinational pharmaceutical companies and top labs in the world. He has six patents and over 100 publications, including five books to his name in AIDS research.
"We are seeing an 85% efficacy rate. That has never been seen in any AIDS drug or vaccine," he said.
In a paper, published in HIV Clinical Trials (Thomas Land Publishers Inc, 2002), 40 patients tracked in a six-month survey experienced an average weight gain of 2.2kg. They also registered a mean increase of 18% and 16%, respectively, in their absolute CD4 and CD8 cells, a measurement of white blood cells responsible for warding off infections.
For end-stage patient survival rate, V1 has kept alive 56.6% of the patients, while those who did not take V1 were all dead within nine weeks. The research on 117 terminally ill patients at the Wat Phra Baht Nam Phu, the largest Buddhist temple in Thailand that cares for dying AIDS patients, was published in HIV Clinical Trials last year.
"If you are a terminal AIDS patient, and you took V1, instead of being dead within two months, you have a more than 50% chance of surviving past two months. Your chance of being alive is still in the 15% range even after one year.
"No antiviral drug in the world today can match that effect. The most advanced antiviral combination therapy in full-blown AIDS patients showed that 16% of treated patients had died versus 23% of patients who were untreated and placed on placebo. That means the difference attributable to antiviral drugs was only 7%, whereas in the V1 study, which dealt with much sicker patients, the difference was between zero and 56.6% survival," said Dr Bourinbaiar.
Independent researcher Dr Orupan Metadilogkul, who was the prime investigator in the research, said one or two of the patients from the study managed to stay alive, got out of the temple and had been living normal lives.
"One still visits me, and that's after two years from the study," said Dr Orupan, an epidemiologist, who is also the president of the Occupational and Environmental Medicine Association of Thailand.
Dr Orupan is currently under investigation by the Public Health Ministry for publishing a paper on 22 cases of AIDS patients who had become HIV-negative after taking V1 between two weeks and 14 months.
Her paper has been lambasted by the ministry's permanent secretary-general Dr Vallop Thaineau as poorly done research, and he accused her of misleading the public into believing that V1 was a cure for AIDS. Dr Orupan had responded by suing him for libel.
Is there a conspiracy?
Last October, a senior medical technologist was found hanged after being blamed by her superiors for making an error in a particular HIV blood test of a patient who was taking V1. Police said they suspected the alleged suicide as a result of issues related to work at the state-run Lerdsin Hospital, where she was working.
Sureeporn Limpasupalerk, 52, had found that the blood test of a HIV-infected person, named Amnuay Phawachalermsak, had become negative after taking the V1 pills. Her report was picked up by the press and made headlines. Seureeporn was questioned by the hospital board after an inquiry by the Ministry of Public Health over her test report, reported The Nation (Nov 3, 2002).
A Thai language paper, the Thai Post quoted a close friend of Sureeporn saying that she had been asked by her to keep some copies of the patient's test results and fight for fairness for her if she was to be put under further investigation.
The paper quoted her friend as saying that the copies she had in hand were those of the original results, which had mysteriously disappeared from the hospital a month after Sureeporn was questioned in August.
At the behest of patients who have been taking V1 and Dr Orupan, the Public Health Ministry ordered a fact-finding committee to be set up to look into the alleged suicide but the case is as good as closed. Nothing concluded, half a year later.
Over the months, independent doctors who had been volunteering at the Bangpakong Clinic have withdrawn their support for the V1, alleging that they had been pressured by their superiors to drop out or have their medical licence revoked.
One of them is a former World Health Organisation (WHO) consultant, who refused to have his name published for fear of repercussions. He was contributing his Saturdays to see patients at the V1 clinic until March.
He said: "In my 20 years of research into vaccines, I have never seen anything like that. This is the first time I have encountered such a vaccine that had such a positive impact on AIDS patients. It is better than any AZTs because for AZTs you have to take more and more, you suffer the side effects and then you develop resistance.
"But with V1, I see the patients getting well and returning to normal life. Instead of dying, they go back to work. This is not by chance. This is because of the product."
He 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.
Asked why he refused to stand by his words publicly, he said: "As a government officer, we survive under a big conflict. I am not as strong as Dr Orupan."
While the V1 continued to be maligned in Thailand, ironically, it has received better acceptance abroad. So far, according to Dr Bourinbaiar, open label clinical tests are being conducted by independent doctors in 35 countries, including 11 in Africa.
More needs to be done, he said, but neither the Thai government nor international AIDS funders have been forthcoming. As a result, V1 research has been criticised for the small number of subjects involved.
"Multinationals put in billions to develop and promote a drug. For V1, Vitchai has managed to develop it with half a million," he said.
The oral presentation by the Scientific Director, Dr. Aldar S. Bourinbaiar, has received warm welcome and tremendous interest from African immunologists and their colleagues on other continents. The presentation summarized the scientific rationale for V1 and clinical findings from 65,000 patients in over 60 countries. The presented work was a result of joint effort of Immunitor scientists with the clinical team led by Dr. Orapun Metadilogkul of Bangkok's Rajavithi Public Hospital, of the Thai Ministry of Public Health.
During the conference Immunitor had initiated and also followed up on already established collaboration with researchers and doctors in Botswana, Burundi, Cameroon, Gambia, Lesotho, Kenya, Mauritania, Mozambique, South Africa, Swaziland, Uganda, Zambia, and Zimbabwe. Plans to build local vaccine production facilities utilizing Immunitor's platform technology was also discussed as part of the future cooperation and development. It is anticipated that sharing of technology between developing countries in Asia and Africa will be synergistic and mutually beneficial for all involved parties.
V-1 Immunitor is a cocktail of fragments of HIV proteins derived from a large pool of primary isolates from blood of HIV carriers.
These protein fragments or antigens are harmless since they are inactivated by heat and chemical means and are then formulated into a tablet. Safe and affordable antiviral treatment is still beyond reach of 99.9% of AIDS patients in Africa. A private Thai
biopharmaceutical company, Immunitor Corp., has developed an oral therapeutic AIDS vaccine called V1. In less than 2 years since the launch of V1 in Thailand, 65,000 AIDS patients have benefited from it. The published evidence in peer-reviewed medical literature and clinical experience in 60 countries worldwide has shown that V1 is safe and effective in alleviating symptoms of HIV/AIDS.
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 genital organs, 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 many HIV subtypes; (3) very large quantities can be manufactured at low cost; (4) it is stable for 3 years at tropical temperature, thus eliminating the need for refrigerated storage and transportation; (5) it is easy to administer (no syringes and no risk of being infected with contaminated needles); (6) it does not require specially trained personnel for mass-vaccination campaigns; (7) the cost of setting a vaccine plant is low and feasible even in the least developed country.
Except V1 no other AIDS vaccine is commercially available in any part of the world. In addition Immunitor's vaccine is the first of its kind to originate from a developing country. Immunitor has pending licenses in several African countries which are expected to be approved shortly.
Mr. Vichai Jirathitikal, President of Immunitor said: 'Our company is a tiny, private company which has independently developed and currently manufactures four types of oral vaccines with little or no support from my government. We are very glad to see the keen interest from so many countries in Africa, whose economies and lives are affected by an AIDS epidemic worse than in Thailand. Our main focus is to establish long-lasting and mutually beneficial cooperation with governments, academic institutions, private sector, and AIDS NGOs in Africa. We seek to produce vaccines jointly so that our partners can be self-reliant and have their own affordable and safe means to fight diseases and economic crises common in our part of the world. We have developed a considerable experience working with our African colleagues and are looking forward to share the success. V1 can be now found in 23 countries in Africa but we are always welcome inquiries and collaboration proposals from other! countries. V1 is not a cure but is the best you can find today.'
For further details contact: info@immunitor.com
Below is the result of your feedback form. It was submitted by info@immunitor.com) on Friday, October 10, 2003 at 12:34:27
name: Aldar S. Bourinbaiar
company: Immunitor Corp., Co., Ltd.
street: 71 Moo 5 Bangpakong Industrial Park
city: c
fax: 1-775-640-6636
where: internet
comment: Immunitor at the 6th International Forum on Global
Vaccinology
An oral presentation - Phase II placebo-controlled study of
therapeutic AIDS vaccine, V-1 Immunitor - was delivered by Dr. Aldar
S. Bourinbaiar, the Scientific Director of Immunitor, at the plenary
session of the 6th International Forum on Global Vaccinology:
Vaccines and Immunization, 25 - 26 September 2003, Minsk, Belarus.
The Forum was organized by the Infections Control World Organization,
Montreal, Canada, and the Research Institute for Epidemiology and
Microbiology, Minsk, Belarus, under auspices of the Ministry of
Public Health of the Republic of Belarus and National Academy of
Sciences of Belarus (http://www.briem.ac.by/eng/konf.html).
The presented study was 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.
V-1 Immunitor (V1) is a polyvalent oral AIDS vaccine which was licensed in Thailand as orally available dietary supplement. Except for V-1 Immunitor no other oral killed vaccine against viruses is available commercially. However, as noted by Dr. Bourinbaiar, there are many killed bacterial oral vaccines on the market. Among these are: a killed whole cell-cholera toxin recombinant B subunit vaccine developed in Sweden (WC/rBS); a simpler version of cholera vaccine without recombinant B subunit manufactured in Vietnam; Soviet tableted cholera vaccine; E.coli oral vaccine against urinary tract infections sold by OM Pharma (Geneva, Switzerland); Czech-made oral vaccines Kanvakol, Alvakol, and Urvakol against several types of bacteria; multibacterial vaccine Luivac against respiratory tract infection from Sankyo (Tokyo, Japan); oral anti-bacterial vaccine, Imocur, to prevent respiratory infections (Zambon, France); Broncho-Vaxom (Fournier, France); tableted Buccaline preparation !
(Berna Biotech/Qualiphar); a broad-spectrum antigenic preparation from Klebsiella pneumoniae Biostim (Aventis Pharma); the Mexican/German anti-bacterial Paspat made as an oral tablet (Altana Pharma); the French oral preparation, Ribomunyl, containing ribosomal fractions of bacteria (Pierre Fabre); Bulgarian polybacterial vaccine Respivax for bronchopulmonary infections; the Polish propionibacterium acne vaccine; and several Russian vaccines for a variety of microbial infections. These vaccine preparations are used as therapeutic and prophylactic modalities. Most clinical trials relating to these vaccines are either unpublished or published in non-English language journals, which makes them virtually unknown to Western vaccinologists. With the exception of, perhaps, cholera vaccine almost all of these vaccines are marketed as immunomodulators or food supplements. However, this misnomer in regulatory terminology is semantic rather than scientific.
Placebo-controlled phase II study of V1 as a prophylactic vaccine in healthy volunteers has been published in January 30, 2003 issue of VACCINE journal (Vol. 21, pages 624-628; http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12531330&dopt=Abstract). However, the clinical experience with V1 as a therapeutic modality was primarily based on open-label studies which demonstrated body weight gain, increase in CD4 and CD8 cells, decrease in viral load, and improved survival of end-stage AIDS patients. In order to substantiate prior non-controlled studies the placebo-controlled phase II clinical trial has been undertaken in 45 asymptomatic volunteers who had over 350/mm3 CD4 T-cells at study entry. The results from 6-month follow-up were as follows: HIV-positive volunteers who received V1 b.i.d. had gained on average 85 CD4 T-cells (543 vs 628). This gain was statistically significant (p=0.0062) while a small increase in T-cell counts (530 vs 576) of !
patients on placebo failed to reach the significance threshold (p=0.32). The clinical benefit of V1 was further supported by steady increase in CD4/CD8 ratio among V1 recipients (0.4455 vs 0.5840, p=0.0011) and decline in CD4/CD8 ratio among patients on placebo (0.5581 vs 0.5113, p=0.15). These results suggest that V1 may reverse the disease progression without any concurrent toxicity. Other immune and clinical improvements were discussed during the presentation and results of this study will be submitted for publication to a peer-reviewed AIDS journal in near future.
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.
'This critical study enforces the value of our product and will be further supported by results of ongoing and planned clinical trials in Africa which is carried out by independent investigators,' said 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".
For further information please contact info@immunitor.com
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