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News/Event Item
Immunitor Company Announces Publication of V-1 Immunitor Clinical Results
5 February 2002
Immunitor Press Release
Immunitor Company announces the publication of an open label trial of V-1 Immunitor (V1) in a peer-reviewed medical journal published in the USA. The scientific paper entitled "Safety and efficacy of an oral HIV vaccine (V-1 Immunitor) in AIDS patients at various stages of the disease" appeared in bimonthly January-February issue of HIV Clinical Trials (http://www.thomasland.com ). Paper describes that HIV-positive patients given experimental oral HIV vaccine, showed strong evidence of clinical benefit. Even more important to the field of vaccine research is the fact that, V-1 Immunitor has already been given to more than 50,000 AIDS patients in Thailand - the largest number in AIDS vaccine history. The mass distribution of V1 was supported by Salang Bunnag Foundation - non-government organization based in Thailand.
Main clinical endpoints in the study were safety of V1 and differential effects on CD4 and CD8 cell counts, plasma HIV RNA levels, and body weight change. Following V-1 Immunitor administration, the number of CD4 T lymphocytes increased so is the number of CD8 cells, which thought to provide cell-mediated immune response and now considered as critical arm of immunity in the fight against HIV. Following six months on V1 the mean increase in absolute CD4 and CD8 cells was 51 (18%; p=0.0088) and 172(16%; p=0.0199) cells per cubic millimeter of blood. Viral load measurements in eight patients have shown statistically significant trend in decrease (Spearman correlation test: r=0.96; p=0.0005). The mean body weight gain following V1 administration was 2.2 kg (p=0.0004). Statistical probability values of obtained data indicate that changes due to V1 administration cannot be attributed to a simple coincidence.
Classic injectable vaccines have the major disadvantage of relying on syringes as the mode of delivery. Patients who are frequently exposed to injections run risk of having life-threatening infections. Almost every AIDS vaccine currently under development is injectable since development of reliable oral delivery is a major challenge for vaccine industry. Immunitor technology has been able to overcome the problem of delivery. It is likely that V-1 Immunitor will be more acceptable alternative for the treatment of diseases, such as HIV, because they are more suitable for administration especially in developing countries, which often lack most basic medical supplies.
V-1 Immunitor is a novel vaccine platform technology that enables oral delivery of virtually unlimited number of immunogen types. Immunitor immunogens are formulated into an ordinary looking pill in a such way that they can withstand the digestive degradation in the stomach but are capable to trigger immune response once presented by the gut cells. The vaccine induces the cellular immune response in the mucosal environment as a means to treat, control or prevent disease. This ability to preferentially target mucosal immune system is a major breakthrough. Any type of disease which requires mucosal immune response, such as infectious diseases, cancer, autoimmune diseases, allergic asthma and allergy, are potential candidates for this technology.
In addition to V1 the Immunitor Corporation developed novel immune-based treatments for cancer, microbial and fungal diseases. These products represent the next generation of vaccines which are deliverable orally.
According to the Joint United Nations Program on HIV/AIDS, today there are 36.1 million people estimated to be living with HIV/AIDS. Of these, 34.7 million are adults and 1.4 million are children under 15. An estimated 21.8 million people have died from AIDS since the epidemic began. During 2000, AIDS caused the deaths of an estimated 3 million people, including 1.3 million women and 500,000 children. Approximately 47%, or 16.4 million, of adults living with HIV or AIDS worldwide are women. Over 95% of people with HIV now live in the developing world without access to antiviral drugs.
Vichai Jirathitikal, the inventor of the technology said, "Our vaccine represents a whole new way of treating patients in the future. People die every day and most cannot afford expensive antiviral drugs. V-1 Immunitor is valuable, life-saving and safe alternative to our patients. Our publication demonstrates the value of Immunitor core technology for the identification of treatment for a variety of human diseases and the discovery of novel potential drug targets. Placebo controlled study is the next step to advance further development of V1".
V-1 Immunitor is currently under investigation in several Asian countries including China, Burma, Cambodia, Laos, India, Malaysia and some countries in Africa. V1 distribution campaign was initiated as a popular grass-roots movement that has started in Thailand in the summer of 2001 (see for details in "V-1 Immunitor: Grass-Roots AIDS Initiative in Thailand". M. Satarayak and T. Laknapichonchat (Eds), Thammasat University, 2001 Seven Printing Group, ISSBN 974-572-907-8).
For reprints contact: Dr. Aldar S. Bourinbaiar; tel: 66-01-931-0116; fax: 1-775-640-6636; email: immunitor@aol.com
The downloadable PDF copy of the article can be found at Publisher's website http://www.thomasland.com
Copyright 2002 Immunitor Company
Permission to reprint this release granted by Dr. Aldar S. Bourinbaiar, Immunitor Company
Immunitor Company website (currently under construction)
http://www.immunitor.com
category: News from Other Sources : AIDS News
contributed by Andrea Welch on 8 February 2002
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