Wednesday’s San Francisco Chronicle reported the exciting news that pharmaceutical company Chiron has changed its decision to stop funding the SILCAAT study of interleukin-2 (IL-2) treatment.
As reported here on aidsmap in October, Chiron had come to the decision that the trial was proving too costly, and was expected to submit licensing applications for IL-2 in the USA and European Union on the basis of an analysis of existing data from the study. SILCAAT is an international randomised study of the use of IL-2 in people with CD4 counts between 50 and 300 cells/mm3 and undetectable viral load on a stable HAART regimen. It is assessing the effect of IL-2 treatment on the risk of opportunistic infections and death.
Chiron began funding SILCAAT back in 1999 and had anticipated the study would take six years and require $75 million to enroll 1,400 patients. By October last year the company had enrolled 1,950 people at a cost of $60 million and had expected the study to take four more years and an additional $100 million to complete.
Speaking to the San Francisco Chronicle, Chiron President Craig Wheeler said “we did not anticipate the amount of support this trial had in the HIV scientific and treatment community.”
Chiron discovered IL-2 in the 1980s and was first approved as an anti-cancer drug in 1992. During the early 1990s a team of researchers led by Cliff Lane at the US National Institutes of Health (NIH) were also investigating IL-2 as a treatment to boost the immune system and prevent HIV from progressing to AIDS.
Although officials at Chiron and the NIH have declined to reveal details about Chiron’s financial commitment to the trial over the coming years, the Chronicle reports that Chiron will provide $5 million annually for the next “three to four years,” this represents a considerable reduction from the $20 million each year the company had originally pledged for four years.
The researchers on this study may well be the ones to feel bear the brunt of the cutbacks; instead of receiving $5,000, they are now more likely to receive around $2,000 per patient. NIH researcher Lane, who brokered the deal, warned that if too many researchers could not cover their own costs and were forced to drop out of the trial, it would likely fall apart, though he expressed his hope that this would not be the case.
More information on IL-2 on this website
Tom Abate. Chiron reversal on AIDS study. San Francisco Chronicle. 15 January 2003.