Important note: Information in this article was accurate in 1996. The state of the art may have changed since the publication date.
Important note: Information in this article was accurate in 1996. The state of the art may have changed since the publication date.
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Reuters NewMedia, Inc. - 9 July 1996
Sarah Edmonds / Reuters
Celgene Corp., a speciality chemicals firm, said Tuesday it plans to file early next year with the Food and Drug Administration for a new drug approval to use thalidomide in the treatment of AIDS wasting, the dramatic weight loss connected with the disease.
Celgene President Dr. Sol Barer said following a symposium on AIDS wasting at the 11th International Conference on AIDS that the company also will apply before the end of the year for approval to use thalidomide to treat ENL, a disorder associated with leprosy.
Thalidomide became one of the worst nightmares of modern medicine in the late 1960s and 1970s when it was prescribed to treat morning sickness in pregnant women and caused thousands of terrible birth defects.
"It's something good coming out of something ... which caused unhappiness to so many," Barer said.
Barer said both of the applications were conditional upon the Warren, N.J.-based company getting encouraging data from on-going trials. He said he was unable to discuss details of a pivotal trial now underway on the treatment of AIDS wasting with thalidomide.
Dr. Morris Schambelan, a professor at the University of California, called the study "exciting."
"I think we are really anxious to see what our data shows on that," he said. "I can only tell you that people who have been involved in open-label (studies) feel well, are eating more and are gaining weight," he added.
The double-blind placebo controlled trial involves 63 patients. Enrollment is now complete on the study.
Thalidomide, one of the most notorious drugs in history, helps prevent the over-production of TNF Alpha in the human body, Barer said.
TNF Alpha is a chemical, which activates the immune system, but its over-production can lead to the proliferation of HIV in the body, as well as to other auto-immune diseases, Barer said.
HIV attacks immune system cells, injecting its genetic material into a cell and then initiating a process that turns it into a virus factory, pumping out more copies of HIV.
Celgene holds licenses for thalidomide as well as a process patent for the treatment of AIDS wasting and a leprosy related disorder. There are also other patents pending, Berer said.
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