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Drug Maker Begins Trials on Bird Flu Vaccines in Humans

Posted on: Thursday, 30 March 2006, 18:00 CST

PHILADELPHIA _ As U.S. health officials warn it may only be a matter of time before the avian flu hits the United States, GlaxoSmithKline PLC said Thursday it has started clinical trials to test two bird flu vaccines in humans.

The London-based drug maker, with U.S. headquarters in Philadelphia, said it is conducting two European trials _ in 400 healthy volunteer adults in Belgium and 400 in Germany _ to test the vaccines' safety and ability to boost protective immune response against the H5N1 avian flu strain, which has killed more than 100 people worldwide.

The vaccines are made from killed, or inactivated, H5N1 virus and should pose no health risks, the company said.

The tested vaccines will contain immune-enhancing chemicals, called adjuvants, to boost the power of the shots, said David Stout, president of GlaxoSmithKline's pharmaceutical operations, in a conference call with reporters.

Preliminary results from the studies are expected in the third quarter, and the company plans to have a vaccine in production before the end of the year.

Drug companies are scrambling to create vaccines or symptom-reducing therapies against H5N1, which has killed millions of birds across Asia, Europe, Africa and now the Middle East. Health officials are worried the virus will mutate and be easily transmitted among people.

Avian flu vaccines are part of a three-point program for pandemic preparedness, GlaxoSmithKline officials said Thursday.

GlaxoSmithKline is spending more than $80 million to increase production of Relenza, an inhaled powder, approved Wednesday by U.S. regulators to treat seasonal influenza in adults and children, 5 and older.

The company is spending about $2 billion on expanding flu manufacturing, including developing new cell-culture technology flu vaccines and innovative immune-boosting adjuvants, which would allow the company to move away from the current way of making influenza vaccines from chicken eggs. The company is expanding its flu plant in Dresden, Germany, and recently acquired ID Biomedical, a Canadian vaccine manufacturer.

"As a result of all our capital investments in flu manufacturing, GSK's capacity to produce a seasonal flu vaccine should grow from today's 30 million doses to around 150 million doses by 2008," Stout said.

GlaxoSmithKline's pandemic vaccines will contain doses of less than 4 micrograms to 30 micrograms of virus antigen, but will be enhanced by adjuvants to boost immune response.

The company is hoping for better results than were reported Wednesday in the New England Journal of Medicine on rival Sanofi Pasteur's H5N1 avian flu vaccine. Sanofi's vaccine contained a high dose, 90 micrograms, of antigen, but did not contain an adjuvant.

Sanofi's vaccine, the nation's first to be tested in people, was found to be only 54 percent effective in producing an immune response to the virus. Sanofi executives said they would work on improving their vaccine.

Shares of GlaxoSmithKline rose 37 cents to $52.63 Thursday.

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(c) 2006, The Philadelphia Inquirer.

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Source: The Philadelphia Inquirer

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