Study of patients with HARS published in Journal of AIDS
ROCKLAND, Mass., March 1 /PRNewswire-FirstCall/ -- Serono
(virt-x SEO and NYSE: SRA) -- Serono's Serostim(R) (somatropin (rDNA origin)
for injection) administered daily decreased visceral adipose tissue in
patients with HIV-associated adipose redistribution syndrome, according to
study data published in the current edition of the Journal of AIDS.(1)
Some people with AIDS or HIV infection develop HARS or HIV-associated
adipose redistribution syndrome, an excessive build up of visceral adipose
tissue combined with metabolic abnormalities. No medical treatment is
currently approved to treat HARS.
"While further study is needed, Serostim(R) has promise as a potential
treatment for visceral fat accumulation in patients with HARS," said Donald P.
Kotler, M.D., St. Luke's Roosevelt Hospital, New York, and a lead investigator
in the study.
The Serostim(R) in the Treatment of Adipose Redistribution Syndrome
(STARS) trial was a multi-center, randomized, double-blind, placebo-controlled
study that included 239 patients at trial sites located throughout the US.
The study was designed to evaluate the efficacy and safety of Serostim(R)
therapy at doses of 4 mg daily or every other day for a period of 12 weeks as
a treatment of abnormal visceral adipose tissue accumulation in HIV-infected
patients with HARS.
The results showed that the decrease in visceral adipose tissue was highly
significant in the Serostim(R) 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(R)
4 mg daily (p<0.001) and alternate day (p<0.001) groups compared to placebo.
Among the study's secondary endpoints was an evaluation of serum total and
non-HDL cholesterol which declined significantly in both the Serostim(R) 4 mg
daily (p<0.005) and alternate day (p<0.015) dose groups compared to the
placebo group.
Adverse reactions reported during this clinical trial were consistent with
those expected within the current approved indication for Serostim(R).
About HARS
HIV-associated adipose redistribution syndrome or HARS is a subset of HIV
lipodystrophy. HIV-associated lipodystrophy is characterized by a variety of
metabolic disturbances and body shape abnormalities that may present
individually or in combination.
Patients with HARS experience abnormal, pathological accumulation of
adipose tissue, which may be present with or without fat depletion and/or
metabolic abnormalities. In general, HARS patients accumulate excess visceral
adipose tissue in the abdomen or may develop a fat pad on the upper back
commonly known as a "buffalo hump."
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, Serostim(R) has a generally
manageable side effect profile. 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 April 17, 2003. 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: SEOZ.VX / SRA.N
Bloomberg: SEO VX / SRA US
(1) Kotler, D, Muurahainen, N, et al. Effects of Growth Hormone on
Abnormal Visceral Adipose Tissue Accumulation and Dyslipidemia in
HIV-Infected Patients. Journal of AIDS 2004, Volume 35, Number 3,
March 1 2004, pp. 239 - 252.
(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.
 back to top
Related links:
http://www.serostim.com
CONTACT:
Serono, Inc., Rockland, MA - Media Relations
- +1-781-681-2340, fax, +1-781-681-2935, Investor Relations,
+1-781-681-2552, fax, +1-781-681-2912, or Serono in Geneva,
Switzerland - Media Relations, +41-22-739-36-00, fax,
+41-22-739-30-85, Investor Relations - +41-22-739-36-01, fax,
+41-22-739-30-22
|
