Serono Announces Results From Pivotal Phase III Clinical Trial of Its Proprietary Recombinant Human Growth Hormone in the Treat
August 17 2006 - 4:05PM
PR Newswire (US)
ROCKLAND, Mass., Aug. 17 /PRNewswire-FirstCall/ -- Serono (virt-x:
SEO and NYSE: SRA) announced today positive results of a pivotal
Phase III trial of Serono's recombinant human growth hormone
(r-hGH) for the treatment of HIV-associated Adipose Redistribution
Syndrome (HARS) at the XVI International AIDS Conference in
Toronto, Canada. Results of the trial were presented as a
late-breaker session on August 17th during the International AIDS
Conference. Serono submitted a supplemental New Drug Application
(sNDA) to the US Food and Drug Administration (FDA) during the
second quarter of 2006. "The findings from the HARS study provide
promising news for the HIV community and for people living with
HARS, a metabolic condition for which there is currently no
approved drug treatment," said Paul Lammers, M.D., M.Sc., Chief
Medical Officer for Serono, Inc. "Visceral fat accumulation and
lipid changes are concerns for HIV patients who are living longer
due to advances in antiretroviral therapy. We are pleased that the
study met all pre-specified primary and major secondary efficacy
endpoints and we look forward to working with the FDA during the
review process." The HARS study, a Phase III, double-blind,
placebo-controlled study, was designed to evaluate recombinant
human growth hormone as a potential therapy for reducing abnormal
accumulations of visceral fat. In HARS study patients, r-hGH 4 mg
daily for 12 weeks significantly reduced visceral adipose tissue
(VAT), trunk fat, non-HDL cholesterol, and improved pre-specified
health-related quality of life outcomes. Maintenance therapy for 24
weeks with a lower dose of r-hGH helped sustain the clinical
benefits. "The results of the HARS study indicate that Serono's
recombinant human growth hormone has a potential role in the
treatment of HIV-infected patients who have increased visceral
adipose tissue," said lead presenter and investigator, Carl
Grunfeld, M.D.,PhD, Professor of Medicine, Chief, Metabolism and
Endocrine Sections, SF Veterans Affairs Medical Center, University
of California at San Francisco. "This is an important finding for a
condition that has a significant impact on HIV-infected patients in
the U.S. who suffer from the consequences of increased visceral
fat." Results of the HARS Phase III Trial 326 patients were
randomized into the trial to determine if daily administration of
r-hGH as treatment for the abnormal fat accumulation and
distribution associated with HARS reduces visceral adipose tissue
as compared to placebo. Patients that had abnormal glucose at the
time of screening into the trial were excluded from the study. The
primary endpoint was change in cross-sectional VAT area on CT scan
measured at vertebral level L4-L5. Key secondary endpoints included
reduction in trunk fat, the impact of reduction in VAT on body
image and patient reported outcomes associated with quality of
life, and changes in lipid parameters, including non-HDL
cholesterol. In the first induction phase of the study, patients
were randomly assigned to receive either r-hGH 4 mg daily, or
placebo for 12 weeks. In the second placebo-controlled maintenance
phase of the study, r-hGH was administered as 2 mg on alternate
days for 24 weeks to assess the ability of a lower dose regimen to
sustain improvements in VAT. At the end of the induction phase, the
mean change (plus or minus SD) in visceral adipose tissue area was
-32.6 plus or minus 37.9cm2 on r-hGH and +0.5 plus or minus 34.5cm2
on placebo (p