Important note: Information in this article was accurate in 1999. The state of the art may have changed since the publication date.
Important note: Information in this article was accurate in 1999. The state of the art may have changed since the publication date.
Reuters NewMedia - Monday, May 3, 1999
Leukine, which stimulates the immune system, kept the virus suppressed and extended the use of antiretroviral drug cocktails in AIDS patients with low levels of the virus in their bodies, the biotechnology company said in a statement.
The phase three study showed that Leukine also reduced the incidence of all infections and death, Immunex said.
As an immune-based therapy, Leukine acts to block HIV entry into uninfected cells, or even restores cells that have been destroyed by the progression of the disease, Immunex said.
The antiretroviral therapies attack the virus itself.
"Immune-based therapies have the potential to protect the immune system from HIV infection, ensure that infected cells remain susceptible to antiretroviral therapies, and ultimately to reestablish the human immune system's ability to fight HIV infections on its own," said Ann Hayes, M.D., senior vice president of medical development at Immunex.
The six-month randomized study involved 309 patients, out of which 115 patients had viral loads less than the level at which Leukine proved effective. Of the 57 patients with undetectable levels of the virus, 83 percent of Leukine patients maintained undetectable viral load at 24 weeks, as compared to 54 percent of placebo patients, Immunex said.
The new data suggests that it is possible to extend the time patients can maintain viral suppression and their response to an antiretroviral regimen, the company said.
Immunex said it will review the results of the Leukine phase three trial with the U.S. Food and Drug Administration this spring.
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