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(R) [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)
HIV-associated wasting is a chronically 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(R). 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(R) on
alternate days, or 0.1mg/kg of Serostim(R) on a daily basis.
Over the 12-week course of therapy, Serostim(R) 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(R) 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(R) 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(R) daily dose group as compared to the
Serostim(R) 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(R) (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(R) 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(R) 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(R)
Serostim(R) [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(R) 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(R) 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(R). Some patients develop diabetic ketacidosis and diabetic coma. In
some patients, therapy with Serostim(R) 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(R). 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(R) must be used in conjunction with antiretroviral
therapy.
Full prescribing information for Serostim(R), including important safety
information, is available at http://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(R) (interferon beta-1a), Gonal-F(R)
(follitropin alfa for injection), Luveris(R) (lutropin alfa),
Ovidrel(R)/Ovitrelle(R) (choriogonadotropin alfa injection), Serostim(R)
[somatropin (rDNA origin) for injection], Saizen(R) [somatropin (rDNA origin)
for injection] and Zorbtive(TM) [somatropin (rDNA origin) for injection].
(Luveris(R) 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
http://www.seronousa.com or by calling 1-888-275-7376.
SOURCE Serono, Inc.
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Related links:
http://www.serono.com
CONTACT:
Serono, Inc., Rockland, MA, Media Relations,
+1-781-681-2340, or Investor Relations, +1-781-681-2552, or
Serono in Geneva, Switzerland, Media Relations, +41-22-739 36 00,
or Investor Relations, +41-22-739 36 01
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