Serono's phase 3 trial of r-hGH to treat HIV-associated HARS meets primary, secondary endpoints

By E. Janene Geiss

Philadelphia, Jan. 9 - Serono announced Monday that its pivotal phase 3 double-blind, placebo-controlled trial of Serono's recombinant human growth hormone in the treatment of HIV-associated adipose redistribution syndrome (HARS) has met all prespecified primary and major secondary endpoints.

Serono said it plans to submit the file to the Food and Drug Administration in the first half of 2006 and expects that the data will be presented at upcoming scientific meetings, according to a company news release.

More than 300 patients enrolled in the trial to determine if daily administration of recombinant human growth hormone (r-hGH) as treatment for the abnormal fat accumulation and distribution associated with HARS reduces visceral adipose tissue more effectively than placebo.

In the first phase of the study, company officials said, patients were randomly assigned to receive either r-hGH 4 mg daily or placebo. Growth hormone was administered for 12 weeks and all patients were measured by CT scan to determine changes in visceral adipose tissue from baseline.

In the second placebo-controlled phase of the study, r-hGH was administered as 2 mg on alternate days for 24 weeks to assess the ability of a maintenance regimen to sustain improvements in visceral adipose tissue.

"The completion of this important research study of r-hGH in HARS is a strategic milestone for Serono and may lead to an important advance for patients living with this condition, that not only affects their health but also their quality of life," Paul Lammers, chief medical officer at Serono, said in the release.

"The rapid enrollment in the study demonstrates the need for treatment for this rare medical syndrome. We anticipate filing a supplemental New Drug Application in the first half of 2006," Lammers added.

Recombinant human growth hormone (r-hGH) is produced by recombinant DNA technology. Serono's r-hGH products are indicated for the treatment of pediatric growth hormone deficiency, adult growth hormone deficiency, HIV wasting or cachexia and for the treatment of short bowel syndrome.

Serono is a Geneva, Switzerland, biotechnology company with a focus on reproductive health, neurology, metabolism and growth. Its current research programs include drug candidates for psoriasis and oncology. Currently, there are about 30 ongoing development projects.

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