Washington Editor

Serono Inc. initiated a Phase III study of Serostim as a treatment and maintenance therapy to reduce excess visceral-fat accumulation in patients with HIV-associated adipose redistribution syndrome.

Serostim (somatropin [rDNA origin] for injection), a growth hormone, is marketed in the U.S. for the treatment of HIV-associated wasting or cachexia. Also, in May, Serono began selling Serostim under the name Zorbtive in the U.S. as a treatment for short-bowel syndrome.

The third indication, HIV-associated adipose redistribution syndrome (HARS), is experienced by people being treated for HIV and there currently is no medical treatment, Serono Inc., the U.S. affiliate of Geneva-based Serono SA, said.

Lisa Ellen, director of corporate communications in Serono's Rockland, Mass., office, told BioWorld Today the company would not comment on other possible indications for Serostim.

The firm's Phase III multicenter, randomized, double-blind, placebo-controlled study will enroll 300 patients at 30 sites. It is designed to evaluate the effectiveness of Serostim at 4 mg administered daily for 12 weeks compared to placebo in reducing abdominal visceral adipose tissue while assessing, among other endpoints, patient-reported outcomes. Also, the trial will evaluate the effect of Serostim at 2 mg administered on alternate days as a maintenance therapy to sustain reductions in visceral adipose tissue attained during the first 12 weeks of active therapy.

Since the firm has just started enrolling the study, Ellen said it is too early to project an estimated date of completion or time frame for filing with the FDA.

HARS is a subset of HIV lipodystrophy, which is characterized by a variety of metabolic disturbances and body-shape abnormalities that might present individually or in combination.

Patients with HARS experience abnormal, pathological accumulation of adipose tissue, which might be present with or without fat depletion and/or metabolic abnormalities. In general, HARS patients accumulate excess visceral adipose tissue in the abdomen and could develop a fat pad of on the upper back, commonly known as a "buffalo hump," Serono said.

Results from an earlier 239-patient study showed that Serostim administered daily decreased visceral adipose tissue in HARS patients. The data, published in the Journal of AIDS, indicated a significant decrease in visceral adipose tissue in the Serostim 4-mg daily group (p<0.001), as compared to placebo. The study also showed that the trunk-to-limb fat ratio, another measure of fat distribution, was significantly reduced in both the Serostim 4-mg daily (p<0.001) and alternate-day (p<0.001) groups, compared to placebo, the company said.

Serono's stock (NYSE:SRA) was up 37 cents Tuesday to close at $15.40.

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