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Glaxo Plans Human Trials of AIDS Vaccine This Year
Ben Hirschler, European Pharmaceuticals Correspondent
February 22, 2001
LONDON (Reuters) - GlaxoSmithKline Plc said on Thursday it aimed to test a novel AIDS vaccine on humans later this year, after studies on monkeys showed it offered protection lasting more than a year. Jean Stephenne, head of vaccine research at the Anglo-American drugs group, told an investor meeting that clinical trials of a prophylactic, or preventative, version of the vaccine were on track to start in the fourth quarter.

GSK -- the world's largest producer of HIV/AIDS medicines -- also hopes to develop a therapeutic version of the vaccine, designed to treat people already infected with the virus that causes AIDS.

The company is not alone in testing AIDS vaccines -- around 25 vaccines are currently being tested on humans around the world. But its high profile in AIDS treatment is likely to add weight to its program. GSK, which has come under fire for its pricing of AIDS drugs in Africa, on Thursday pledged to widen a scheme to supply poor countries with treatments at discounts in excess of 90 percent.

Stephenne said the intention was to combine the vaccine with GSK's standard triple-combination anti-retroviral drugs. Patients would be get the usual drug "cocktail" to reduce the amount of virus in their body and then receive the vaccine to keep them well.

Trials on this therapeutic use of the product are due to start in early 2002 and results on the feasibility of the process should be available around mid-2003.

Other companies working on AIDS vaccines include VaxGen Inc, which is conducting advanced Phase III trials of its AIDSVAX vaccine, as well as GSK's "big pharma" rivals Merck and Co Inc and Aventis SA.

GSK's vaccine consists of purified proteins from the HIV virus in a novel adjuvant, a material added to vaccine preparations to improve the immune response.

Vaccines work by helping the body recognize and act against invaders, by using antigens, which are the recognition part of the equation, and adjuvants, that help boost immune system cells.

Stephenne said the results of GSK's studies on rhesus monkies, showing a sharp reduction in viral load and an increase in CD4 immune cells in animals given the vaccine, would shortly be published in a scientific journal.

A vaccine is seen as the best long-term hope in stopping the spread of HIV which the World Health Organization estimates has infected more than 36 million people worldwide.



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