AEGiS-Bangkok Post: Drug firm denies it has quit vaccine trial: Clinical phase ends, now checking data Bangkok PostImportant note: Information in this article was accurate in 2003. The state of the art may have changed since the publication date.
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Drug firm denies it has quit vaccine trial: Clinical phase ends, now checking data

Bangkok Post - July 4, 2003
Aphaluck Bhatiasevi


Aidsvax manufacturer VaxGen Incorporated yesterday denied it was withdrawing financial support for a Thai vaccine trial involving 2,500 volunteers.

"VaxGen has not withdrawn financial support required to complete the trial. VaxGen remains committed to completing its Phase III trial in Thailand, including final analysis of the data from this study," said Kesinee Angkustsiri Yip, associate communications director of the California-based firm.

She said that the clinical portion of the trial had finished and the firm planned to announce the results in this year's fourth quarter.

The US National Institute of Allergy and Infectious Diseases and the US Centre for Disease Control and Prevention (CDC) were holding a a series of meetings with VaxGen to examine data from the company's Phase III trial in North America and Europe to determine if further government-supported research and development were warranted, she said.

The meetings with the two US agencies also discussed the possibility of providing financial and technical support for the Phase III clinical trial in Thailand, Ms Kesinee said.

She was responding to Monday's statement by Kachit Choopanya, principal investigator for the vaccine trial, that VaxGen had decided to stop providing the financial support needed to complete the trial.

Mr Kachit also insisted the project would go ahead despite VaxGen's withdrawal of financial support.

The Aidsvax vaccine trial is being administered by the Bangkok Metropolitan Administration, Mahidol University's faculty of tropical medicine, with collaboration between the Public Health Ministry, the CDC and VaxGen.

Dr Kachit yesterday stood by his earlier remarks. He also said it would make no difference whether VaxGen continued to support the trial or not as most of the administrative work had been done, including the giving of injections to volunteers and data compilation.

Only information analysis remained to be done, he said. No timeframe was available.

Aidsvax is a preventive vaccine especially designed with the B/E strain of the HIV virus because its subtype E is most common in Thailand.

It is one of two vaccines to be used in another clinical trial due to begin at the end of this year in Rayong and Chon Buri provinces, involving 16,000 volunteers.

The new trial will be administered by the Public Health Ministry and the US Armed Forces Research Institute for Medical Science.

In February, VaxGen released the results of the trial in the US, stating that the vaccine was 3.8% effective.

The company, however, raised hopes that the vaccine could work on Asian people more than Caucasian people.


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