Bangkok, Thailand: The Privately held Thai biotech company "Immunitor Corporation Co., Ltd" has submitted to the Thai FDA the application for a Phase III clinical trial to Thailand's Food and Drug Administration (FDA). The application is based on pending investigational R&D drug permit that was granted in the year 2000. The primary endpoint of the trial is aimed at confirming the beneficial property of V-1 Immunitor (V1) shown for AIDS-associated wasting.

When approved, a study will be carried out in Thailand by the clinical team of Dr. Orapun Metadilogkul, the President of Occupational and Environmental Medicine Association of Thailand at the Rajavithi General Hospital in Bangkok, one of the largest public hospitals in Thailand.

Recently published retrospective, large-scale studies of 650 AIDS patients demonstrated that V1 Immunitor was safe, effective, and highly promising as an inexpensive therapy for the management of opportunistic infections and AIDS-associated decline in body mass. The findings of those stusies support the results of open label phase I study on V1 Immunitor published two years ago and of placebo-controlled phase II study of V-1 Immunitor completed last year.

V-1 Immunitor is an orally available therapeutic AIDS vaccine, which has been licensed in Thailand and certain countries in Africa as a dietary or food supplement. The vaccine elicits mucosal immune response in the gut, which appears to result in reversal of weight loss in 76% of AIDS patients. Several published clinical trials have shown that V-1 Immunitor is safer and cheaper than standard antiviral therapy for AIDS / HIV.

The Phase III trial seeking licensure for AIDS-related wasting represents a "streamlining" of the Company's approval strategy. Obtaining drug label for such an indication is a stepping stone for V1 Immunitor's ongoing research program aimed at developing effective and safe vaccine for treatment and prevention of HIV."

Principal Investigator, Dr. Aldar S. Bourinbaiar, the Scientific Director of the Company, said, "Our results compare very favorably to any published results of treatment for this indication. The results we have seen are the best I've observed with this difficult-to-treat condition, which is associated with certain death. Currently available nutritional supplements or cocktail antiviral drugs known as HAART are inefficient for correction of wasting and V1 Immunitor can be useful add-on option to HAART or as stand-alone therapy. Other treatment options like recombinant human growth hormone (HGH), produced by Swiss company Serono, are quite effective but they are too expensive for third world countries."

Mr. Vichai Jirathitikal, the Chairman of the V-1 Immunitor, said, "We plan to initiate a similar Phase III multi-site trial program for V1 Immunitor in four countries in Africa. Depending on ethics committees' decision in respective countries the trials will start sometime before International AIDS Conference to be held in July of this year in Bangkok, Thailand. We are especially proud that our charitable work which provided free V1 Immunitor treatment to more than 40,000 AIDS patients in Thailand and other developing countries led to the nomination of the Company for 2004 Bill Gates Award in Global Health."

For more infor visit: V1 Immunitor Thailand