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VaxGen's Phase III Trial in Thailand clears final scheduled safety review
California | Thursday, October 24, 2002, 08:00 Hrs  [IST]

The independent board that oversees VaxGen Inc's clinical trials has completed the final safety and conduct review of the company's Phase III trial in Thailand and once again concluded that the study was being conducted appropriately and that VaxGen's AIDS vaccine candidate appears safe, VaxGen Inc announced.

VaxGen is conducting two Phase III trials, one in Thailand and another in North America and Europe. The oversight board, or Data and Safety Monitoring Board (DSMB), completed its final safety review of the trial in North America and Europe in April 2002 and therefore focused solely on the trial in Thailand in its most recent evaluation.

In its seventh review of the Thai trial, the DSMB found that VaxGen's AIDS vaccine candidate, AIDSVAX B/E, continues to exhibit a very good safety profile. More than 32,000 injections of AIDSVAX have been administered since it entered human clinical trials. VaxGen is testing AIDSVAX B/B in North American and Europe.

Retention of volunteers in the Thai study remained above expectations. On an annualized basis, 96.7% of the volunteers in the trial continued to participate as of September 15, 2002.

The DSMB also conducted an interim analysis of efficacy using data from the trial in Thailand and recommended that the study continue to its planned conclusion in the second half of 2003. The DSMB would have recommended concluding the trial prematurely if the vaccine had proven effective ahead of schedule. The DSMB, which is composed of prominent scientists, researchers, clinicians, AIDS specialists, vaccinologists, biostatisticians and an ethicist, disclosed no information regarding vaccine efficacy.

VaxGen expects to announce primary efficacy results from the trial in North America and Europe in the first quarter of 2003 and similar results from the study in Thailand in the second half of 2003.

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