Serono Laboratories Inc. said Wednesday that it filed anew drug application (NDA) seeking approval of itshuman growth hormone to treat AIDS wasting.

The product, called Serostim for that indication, is amammalian cell-derived recombinant human growthhormone. Serono has an NDA on file seeking approval ofits human growth hormone to treat short children withgrowth hormone insufficiency called Saizen.

Serono, of Norwell, Mass., already is providing its drugunder an FDA treatment investigational new drug (TIND)program. None of the other growth hormone products hasshown the clinical benefit in AIDS wasting as hasSerostim.

AIDS wasting, cachexia, is defined as a loss of 10 percentor more of a person's body weight, and is an indicator ofprogression from HIV infection to disease. The condition,Serono said, is a metabolic dysfunction that causes a bodyto burn muscle and organ tissue rather than fat. "Growthhormone is able to reverse that process," said Gina Cella,Serono's director of corporate communications. "It's ableto maintain and build lean body mass while using the fatappropriately."

One 178-patient placebo-controlled Phase III studyshowed patients taking Serostim gained an average of 6.6pounds of lean body mass, while losing an average of 3pounds of fat. Those who gained lean body massperformed better on treadmill endurance tests. The NDAalso contains data suggesting the drug impactsimmunological parameters, the company said.

Phase II studies of Serostim showed it had both protein-building and protein-sparing effects, and that those takingthe drug gained weight and body mass.

In August, California's Medicaid program, Medi-Cal,agreed to provide full reimbursement coverage forSerostim for those with AIDS wasting. That marked thefirst TIND product covered by Medi-Cal.

Serono Laboratories is the U.S. unit of The Ares-SeronoGroup, of Geneva, Switzerland. Serono said the SerostimNDA was filed on Sept. 11, 1995. n

-- Jim Shrine Staff Writer

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