Fwd: “PinkPanacea”, at last a vaccine against AIDS?

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3 Apr 2004 15:45:01 -0000

“PinkPanacea”, at last a vaccine against AIDS?

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" Pink Panacea " , at last a vaccine against AIDS?

 

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Sam Burcher reports on an unconventional vaccine that could

provide treatment for AIDS

 

A fully referenced version of this report is posted on ISIS

website.

 

www.i-sis.org.uk/PinkPanacea.php

 

For a referenced version

 

www.i-sis.org.uk/full/PinkPanaceaFull.php

 

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A company based in Thailand has developed an oral vaccine

against HIV/AIDS. The makers of a pink pill called " V1 " ;

claim striking success in the treatment of HIV/AIDS symptoms

[1].

 

 

Immunitor Corporation Company and V1's creators are clinical

researcher Dr Aldar S. Bourinbaiar and pharmacist Vichai

Jirathitikal who have put V1 through a placebo-controlled

phase II study. The results showed significant improvements

in CD4 and CD8 cell counts, weight gain, decreased viral

load and survival of end-stage AIDS patients. It also

suggested that the V1 could reverse the progression of AIDS

without concurrent toxicity [2].

 

 

Immunitor and Dr Orapun Metadilogkul, an independent

physician who heads the Thailand Association of Occupational

and Environmental Medicine Physicians, claim that 27

patients diagnosed with HIV/AIDS have seroconverted from HIV

positive to HIV negative after treatment with V1. A phase

III trial application has been submitted to the Thai Food

and Drug Administration (FDA) aimed at demonstrating the

beneficial properties of V1 on associated symptoms of AIDS

such as wasting. If approved, trials will take place at the

largest public hospital in Bangkok under Dr Metadilogkul.

 

 

V1 is said to be a therapeutic vaccine comprising " HIV

antigens from pooled clinical isolates from HIV infected

donors " . These antigens are made into pills taken orally

that do not degrade in the digestion process of the stomach,

but trigger immune responses in the underlying mucosa-

associated immune cells in the lining of the small

intestine.

 

 

Some 90% of the immune cells in the human body are made up

of lymphocytes and monocytes in the lining of the mucosal

surfaces. So there are ten times more CD4 and CD8

lymphocytes residing in the mucosal lining than in the blood

where only 2% of lymphocytes are present. According to

Immunitor, these intestinal cells are the front-line defence

against HIV and are the first to be destroyed or disabled by

the virus.

 

 

Once mucosal immunity has failed, the common and often fatal

symptoms of HIV/AIDS appear, such as diarrhoea and

respiratory infections. V1 works on the premise that

HIV/AIDS is a disease of mucosal immunity, so targeting

antigens at mucosal surfaces is a valid clinical approach.

 

 

Public opinion on V1 came sharply into focus when Thai

clinics began giving out the pink pills free of charge to

AIDS patients at mass rallies organised in schools, police

stations, sport stadiums and Buddhist temples. There was

opposition to these actions by a number of workers in

conventional medical practices, despite the fact that they

have no effective treatment to offer to patients with

HIV/AIDS.

 

 

V1 is extensively subject to toxicity studies both in vitro

and in vivo. So far, studies by the Thai government and

independent private laboratories have proved it exhibits no

toxicity. Five mammalian cell lines tested at the highest

dose of 10mg/ml showed no sign of cytotoxicity. The

extrapolated dose of V1 that would cause death in humans is

2 200 pills per day, as against the recommended daily dose

for adults of one or two pills per day.

 

 

Recently published data from Immunitor shows that 40 AIDS

patients on a six month trial of V1 treatment increased

their CD4 and CD8 cells counts by a mean average of 51 cells

(19%) per microlitre of blood. Increase in body weight was

2.2 kg on average. But some patients'weight increased by as

much as 30 kg, which is an important gain in the treatment

of AIDS.

 

 

These encouraging results led Bourinbaiar and Jirathitikal

to evaluate V1 therapy in the treatment of terminally ill

AIDS patients in intensive care wards in Thai hospitals.

They approached 117 patients and 53 decided to take V1 while

64 declined treatment. All patients were bedridden and had

been receiving palliative care. None of the patients had

access to conventional anti-retroviral drugs, but some had

been treated with antibiotics. All the patients in the non-

V1 group were dead by week 9. In contrast 30 out of the 53

in the V1 group were alive and able to resume normal

activity.

 

 

After 20 months on V1, 18% of patients who started with

almost zero CD4 counts were still alive. It was also noted

that patients receiving V1 seldom developed opportunistic

infections, which further suggests that V1 improves mucosal

immune responses to infections.

 

 

A retrospective analysis by Bourinbaiar and Jirathitikal of

650 HIV positive patients who had taken V1 for an average of

twenty-three weeks showed significant results. In total, 496

(76%) were able to increase their body weight or at least

maintain weight on the V1 regime; 389 (59%) gained 4.2 kg,

while 107 (17%) remained unchanged and 159 (24%) lost

weight. Everyone participating in the trial was able remain

on it and suffered no serious side effects [3].

 

 

A further study took place whereby V1 was administered to

the HIV-negative relatives of terminally ill AIDS patients

over a median period of twenty-four days. Their blood was

then transfused into the AIDS patients who experienced an

improvement in their health. Results showed that increases

in CD4 and CD8 counts were statistically significant [2].

 

 

V1 is currently licensed as a food supplement by the Thai

Food and Drug Federation (FDA) and is produced for R & D

purposes. A one months supply costs around $20-£30 per

person, but it is given freely to poor patients in public

hospitals wherever possible. So far 65 000 Thais infected

with HIV have been given the treatment.

 

 

Costs for V1 contrast strikingly with those of more

established combination therapies or " cocktails " consisting

of three-drug antiretroviral treatments of HIV/AIDS. A

recent HIV Cost Services Utilization Study Consortium

Analysis estimates that in the USA, 33 500 HIV infected

adults seen twice a year for medications and blood tests

spend $6.7 billion or $22 000 per patient per year [4].

Apart from the economic viability of V1, there may be other

advantages when considering its use as a safe therapy for

the developing world. It has broad-spectrum activity against

many HIV subtypes and is stable in ambient tropical

temperatures for three years, making refrigeration

unnecessary. And no special skills or syringes are needed to

administer the pill [5].

 

 

Immunitor is not disclosing the medicinal properties of V1,

but instead recommend a cocktail of V1 and certain generic

drugs as alternative and inexpensive treatments for

HIV/AIDS. They cite examples of five compounds: gramicidin

(the first antibiotic to be isolated), cimetidine (Tagamet),

warfarin, (a common anti-coagulant), levamisole (an animal

de-wormer), originally developed for animal use, but

latterly became a useful drug in treating colon cancer in

humans, and acetaminophen (Paracetamol). Immunitor says

these unapproved drugs are all highly effective against

HIV/AIDS and are incredibly cheap in comparison to approved

combination therapies [6]. (See Alternative AIDS Therapy

from Cheap Generics, this series)

 

 

Clinical trials of V1 are ongoing and phase III trials are

scheduled for Africa with results pending. It is registered

in Ghana and licenses have been applied for in several other

African states. Immunitor hopes to build a vaccine plant to

supply large amounts of V1 to Africans at low cost. This

would meet a critical demand for affordable and available

HIV/AIDS treatment in the Continent.

 

 

Much attention is centred on the high rates of infection and

death, 95%, caused by HIV/AIDS in the developing world. But

until recently the intimate association between the pandemic

and poverty has been played down in the application of

strategic approaches for HIV/AIDS. In his recent letter to

The Times newspaper Prof. Kenneth Stuart, the medical

advisor to the Commonwealth Secretariat, highlighted the

need to recognise the role of poverty in effective

treatments for HIV/AIDS. He says " The more the gap widen

between rich and poor the greater the number of people who

are left stranded in the backwaters of progress. " So not

only are people in poverty traps deprived access to helpful

technologies and medicines their ability to acquire

knowledge is diminished along with their human rights [7].

 

 

The report " Thailand Social Monitor: Poverty and Public

Policy " says 16 per cent of the country's population, or

about 10 million people, are now living on less than the

minimal income of Bt900 per person per month, which

constitutes the country's poverty line [8].

 

 

" Poverty is re-emerging as one of the nation's most serious

problems, " said Ian Porter, the World Bank's country

director for Thailand at the launch of the new report, which

was jointly prepared by the National Economic and Social

Development Board, the Thailand Development Research

Institute and international experts [9].An international

AIDS conference will be held in Bangkok in July 2004.

 

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