Serono's
Serostim(R) Improves Lean Body Mass and Physical Performance
in Patients With HIV-Associated Wasting .
Posted
on Mon, Apr. 05, 2004 / By Cathy
Results
of largest study of recombinant human growth hormone in HIV-associated
wasting published in current issue of the Journal of AIDS
ROCKLAND,
Mass., March 31 /PRNewswire-FirstCall/ -- Serono (virt-x: SEO
and NYSE: SRA)-Serono's Serostim® [somatropin (rDNA origin)
for injection] improves lean body mass and physical performance
in patients with HIV- associated wasting, according to study
data published in the current edition of the Journal of AIDS
("Growth Hormone Improves Lean Body Mass, Physical Performance,
and Quality of Life in Subjects with HIV-Associated Weight Loss
or Wasting on Highly Active Antiretroviral Therapy"). (1)
debilitating
and potentially life- threatening condition. It is a metabolic
disorder that causes the loss of lean body mass, which includes
muscle tissue, important body organ tissue and blood cells,
and can lead to increased risk of opportunistic infections,
illness, and extreme fatigue and can profoundly diminish a person's
quality of life.
The present study, the largest randomized, double-blind placebo-controlled
study of recombinant human growth hormone in HIV-associated
wasting, confirmed the efficacy, safety and tolerability of
Serostim®. The study treated 757 patients with HIV-associated
wasting at US, European and other international trial sites.
Participants were treated with placebo, 0.1 mg/kg Serostim®
on alternate days, or 0.1mg/kg of Serostim® on a daily basis.
Over the 12-week course of therapy, Serostim® was superior
to placebo in improving physical function, lean body mass and
body weight and had a positive effect on patient perception
of the benefits of therapy.
"People with HIV still involuntarily lose both weight and
lean body mass, despite the adoption of highly antiretroviral
therapy," said Joseph M. Gertner, MD, Vice President of
Medical Affairs, Metabolic Endocrinology, Serono, Inc. "As
demonstrated by these study results, Serostim® is the only
therapy shown clinically to build body mass and improve physical
function in people with HIV-associated wasting."
The result on the study's primary endpoint of cycle work output
was statistically significant for the Serostim® as compared
to the placebo group (p<0.001). Greater improvement was seen
for the secondary endpoint of change in lean body mass for the
Serostim® daily dose group as compared to the Serostim®
alternate day group (p=0.017) and as compared to the placebo
group (p<0.001). In addition, patient perception of the impact
of treatment on their wasting symptoms was positive with both
doses of Serostim® (p=0.002 for the alternate day group
and p=0.0004 for the daily dose group) as compared to placebo.
Bodily pain increased in a dose dependent manner for both treatment
groups, but the pain did not interfere with the subjects' normal
work.
This study also provides long-term efficacy and safety information
for up to 48 weeks of Serostim® treatment in a subset of
participants. When treatment was extended from 12 to 24 or 48
weeks, positive results in cycle work output and lean body mass
either improved further or were maintained with continued treatment
with Serostim® at both the daily and alternate day dosing.
Adverse reactions reported during this clinical trial were consistent
with those included in the current product labeling.
About Serostim®
Serostim® [somatropin (rDNA origin) for injection] is the
only growth hormone approved by the US Food and Drug Administration
for the treatment of HIV-associated wasting or cachexia. The
recommended dose is 0.1 mg/kg daily (6 mg/day for patients >
55 kg). Serostim® 0.1 mg/kg every other day should be considered
as a starting dose in patients thought to be at risk of certain
adverse effects, i.e., glucose intolerance.
In patients with HIV-associated wasting, the most common adverse
events associated with Serostim® therapy are mild to moderate
muscle and joint pain and swelling, which occur in a dose-related
manner and often subside with continued treatment or dose reduction.
Cases of new onset impaired glucose intolerance, new onset Type
2 diabetes mellitus and exacerbation of preexisting diabetes
mellitus have been reported in patients receiving Serostim®.
Some patients develop diabetic ketacidosis and diabetic coma.
In some patients, therapy with Serostim® necessitated initiation
or adjustment of anti-diabetic treatment. Patients with a history
of hyperglycemia or other risk factors for glucose intolerance
should be monitored closely during treatment with Serostim®.
Transient increases in glucose levels occur early in treatment
and should be monitored.
Use of growth hormone is contraindicated in treatment of patients
in intensive care units due to complications following open-heart
surgery or abdominal surgery, multiple accidental trauma or
acute respiratory failure; patients with active neoplasia; and
patients with known hypersensitivity to growth hormone. Serostim®
must be used in conjunction with antiretroviral therapy.
Full prescribing information for Serostim®, including important
safety information, is available at www.serostim.com .
About Serono
Serono, Inc., located in Rockland, MA, is the US affiliate of
Serono, a global biotechnology leader, headquartered in Geneva,
Switzerland. The Company has seven recombinant products, Rebif®
(interferon beta-1a), Gonal-F® (follitropin alfa for injection),
Luveris® (lutropin alfa), Ovidrel®/Ovitrelle® (choriogonadotropin
alfa injection), Serostim® [somatropin (rDNA origin) for
injection], Saizen® [somatropin (rDNA origin) for injection]
and Zorbtive(TM) [somatropin (rDNA origin) for injection]. (Luveris®
is not approved in the USA.)(2) In addition to being the world
leader in reproductive health, Serono has strong market positions
in neurology, metabolism and growth. The Company's research
programs are focused on growing these businesses and on establishing
new therapeutic areas. Currently, there are approximately 30
ongoing development projects.
In 2003, Serono achieved worldwide revenues of US$2,018.6 million,
and a net income of US$390.0 million, making it the third largest
biotech company in the world. Its products are sold in over
90 countries. Bearer shares of Serono S.A., the holding company,
are traded on the virt-x (SEO) and its American Depositary Shares
are traded on the New York Stock Exchange (SRA).
Some of the statements in this press release are forward looking.
Such statements are inherently subject to known and unknown
risks, uncertainties and other factors that may cause actual
results, performance or achievements of Serono S.A. and affiliates
to be materially different from those expected or anticipated
in the forward-looking statements. Forward-looking statements
are based on Serono's current expectations and assumptions,
which may be affected by a number of factors, including those
discussed in this press release and more fully described in
Serono's Annual Report on Form 20-F filed with the U.S. Securities
and Exchange Commission on March 25, 2004. These factors include
any failure or delay in Serono's ability to develop new products,
any failure to receive anticipated regulatory approvals, any
problems in commercializing current products as a result of
competition or other factors, our ability to obtain reimbursement
coverage for our products, and government regulations limiting
our ability to sell our products. Serono has no responsibility
to update the forward-looking statements contained in this press
release to reflect events or circumstances occurring after the
date of this press release.
For
more information, please contact:
Serono,
Inc., Rockland, MA
Media Relations: Investor Relations:
Tel. +1 781 681 2340 Tel. +1 781 681 2552
Fax: +1 781 681 2935 Fax: +1 781 681 2912
Serono
in Geneva, Switzerland:
Media Relations: Investor Relations:
Tel: +41-22-739 36 00 Tel: +41-22-739 36 01
Fax: +41-22-739 30 85 Fax: +41-22-739 30 22 http://www.serono.com
Reuters: SEO.VX / SRA.N
Bloomberg:
SEO VX / SRA US
(1) Moyle, G, Daar, E, Gertner JM, et al. Growth Hormone Improves
Lean
Body Mass, Physical Performance, and Quality of Life in Subjects
with
HIV-Associated Weight Loss or Wasting on Highly Active Antiretroviral
Therapy. Journal of AIDS 2004, Volume 35, Number 4, April
1 2004, pp.
367 - 375.
(2)
Package inserts for Serono's US marketed products are available
at www.seronousa.com or by calling 1-888-275-7376.
Distributed by
Serono, Inc.
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