Important note: Information in this article was accurate in 2002. The state of the art may have changed since the publication date.
Bangkok Post - April 29, 2002
Anjira Assavanonda
Information has been leaked from the FDA that Trinity Medical Group, which is overseeing development and distribution of the vaccine, commercially known as Remune, in Southeast Asia, approached the FDA in January this year, asking for registration of Remune as an immune response substance for treatment of HIV/Aids patients.
FDA sources said Trinity Medical Group had asked for an exemption from Certificate of Free Sale, an important document issued by the country of manufacture, in this case the US, which is normally required in the FDA registration process for newly imported drugs.
In a leaked document dated Jan 11, Trinity Medical Group claimed that from the five-year phase II study, Remune had resulted in HIV-positive volunteers getting increased CD4 cell counts and decreased viral loads. It also reduced the rate of progression from HIV to Aids to 0.17% (compared to 6% of those who were not given the vaccine).
The company said it was seeking the exemption because Remune had never been registered in any other country.
There was also evidence showing that the company had invited a group of FDA officials to visit Immune Response Corp, Remune's manufacturer in the US, in March to advise the firm on FDA regulatory and documentary processes for registering Remune.
The vaccine was earlier reported to be undergoing phase-I safety and phase-II immunogenicity trials in Thailand. However, after problems with interpreting results obtained in the second phase and observation of insignificant progress among candidates given the vaccine, the evaluation panel decided to call for a repeat of the phase II trial early last year.
The suspension of the trial, however, could not deter lead researcher Vina Churdboonchart who instead had proposed to go ahead with the large scale phase III trials involving some 10,000 HIV-infected volunteers.
The authorised panel, however, decided to wait for results of the extended phase II study on 297 HIV-positive people which is expected to come out by August 2003 before going any further.
The issue had temporarily subsided until Trinity Medical Group made another move to the FDA early this year.
Following the leak of information, the issue was brought to the Drug Commission last Friday. Vichai Chokeviwat, FDA secretary-general and also one of the commissioners, said the commission had not considered the company's request for certificate exemption, but had set up a special panel to study information concerning the product's safety and efficacy.
Dr Vichai said there were only two drugs which had ever been given that exemption. One is a malaria remedy which is manufactured in Switzerland and the other is a remedy for cancer.
They were granted the exemption because they were considered to provide big benefits to patients.
In the case of Remune, he said the commission was considering whether it was a better option for treating HIV/Aids.
Anti-retroviral treatments had not produced satisfying results.
However, questions still remained on Remune's efficacy. Dr Vichai said the vaccine was not given Certificate of Free Sale from the US because the product was unlikely to be manufactured there.
In May 1999, a US Data and Safety Monitoring Board advised Immune Response to halt its phase III trial of Remune because differences in clinical endpoints were not observed between those who added the vaccine to their anti-retroviral therapy and those who did not.
Dr Vichai, however, noted Remune still held some advantages since it had fewer side effects than anti-retroviral drugs, and did not have to be taken every day, unlike anti-retroviral therapies.
Meanwhile, Jon Ungphakorn, a senator and Aids activist, said he was against hasty moves to register the substance. Foreign Aids researchers had said that Remune failed to reduce the virus in the bloodstream.
He also questioned the ethics of the lead Thai researcher, Ms Vina, as she also holds a stake in Trinity Medical Group, which is corporate partner of Immune Response Corp in Southeast Asia.
"As long as there is no proof that Remune could benefit the health of HIV-infected people, I don't see any point in having it registered,"said Mr Jon.
The substance would be no different from V-1 Immunitor, another controversial proported Aids cure remedy distributed by the Salang Bunnag Foundation. "The move could be seen merely as a marketing strategy to sell the products without proving its efficacy," Mr Jon said.
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