Important note: Information in this article was accurate in 2002. The state of the art may have changed since the publication date.
Bangkok Post - May 3, 2002
Anjira Assavanonda
Their backing comes amid recent reports that the manufacturer was seeking FDA approval to register Remune as an immune-based therapy for treating HIV/Aids patients without the Certificate of Free Sale, an important document normally required under the FDA registration process.
Vina Churdboonchart, an associate professor at the Department of Pathobiology, Mahidol University, said HIV-1 Immunogen had already undergone phase I safety and phase II immunogenicity trials in five respected medical institutions in Thailand, Khon Kaen University, Chiang Mai University, Songkhla University, Vachira and Phra Mongkutklao hospitals, with satisfying results.
Ms Vina is a part-owner of the Trinity Medical Group Inc (TMG), joint developer and distributor of Remune in Southeast Asia. She said the studies were conducted in a straight-forward manner and followed international protocols requiring safety trials in animals and the immunogenicity trials on humans.
``After five years of studies, our trials are finally moving in the right direction, with our volunteers showing a significant improvement in health,'' said Ms Vina.
Visut Sukeepaisarncharoen, a researcher at Khon Kaen University, said that in the phase II trial involving 297 HIV-infected volunteers, 198 received the vaccine while 99 were placed on a placebo.
It was found that only those given the vaccine showed an increase in their CD4 counts (immunity level in white blood cells) after 40 weeks.
After 132 weeks, from the 235 volunteers left in the trial, 65% not only showed an increase in their CD4 counts but also a decrease in their viral loads, meaning their health had improved.
The results also showed that the progression to Aids had been detected in only three of the 235 volunteers (0.72 per 100 people per year) compared to a normal progression rate of 6.8 per 100 people a year in the Thai population.
Dr Visut said Remune had also succeeded in preventing the HIV virus from mutating which made the treatment more effective.
It was earlier reported that Remune had failed to win endorsement from the evaluation panel because results of the phase II trial did not impress.
Ms Vina, however, said the report was based on a misunderstanding, and that the ethics sub-committee considering vaccine trials on humans had already approved the phase III trial, which has been continued with the same group of volunteers from phase II.
The extended trial, she said, was being conducted at Songkhla and Khon Kaen universities. Asked why she did not wait for the completion of the last trial before applying for the drug's registration with the FDA, Ms Vina said since Remune had already proved its effectiveness to a degree, she thought it would be wise to put it on the market.
Asked why the vaccine was not given the Certificate of Free Sale by US authorities, Ms Vina said no such application was made by Immune Response Corp, which makes Remune in the US.
But reports have it that the phase III trial on 2,500 volunteers in the US was stopped following an analysis of the trial results which failed to detect a difference in clinical endpoints between patients receiving anti-retroviral drugs, with or without Remune. Ms Vina said researchers ended the trial because a large number of volunteers withdrew from the long-running trial and the remaining number were insufficient for accurate data analysis.
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