Study Aimed at Assessing Benefits of Recombinant Human Growth Hormone as
Potential Treatment and Maintenance Therapy for HIV Metabolic Complication
GENEVA and ROCKLAND, Mass., June 1 /PRNewswire-FirstCall/ -- Serono, Inc.,
the US affiliate of Serono (virt-x: SEO and NYSE: SRA), announced today that
the company has initiated a Phase III clinical trial of Serostim(R)
[somatropin (rDNA origin) for injection] as a potential treatment and
maintenance therapy to reduce excess visceral fat accumulation in patients
with HIV-associated adipose redistribution syndrome (HARS). HARS is a
potentially debilitating medical condition experienced by people being treated
for HIV for which there is currently no medical treatment. The visceral
adipose tissue accumulations seen in HARS may also be associated with an
adverse risk profile.
This multi-center, randomized, double-blind, placebo-controlled study of
the safety and efficacy of Serostim(R) in HARS will include approximately 300
patients at 30 clinical trial sites. The study will evaluate the
effectiveness of Serostim(R) 4mg administered daily for 12 weeks compared to
placebo in reducing abdominal visceral adipose tissue while assessing, among
other endpoints, patient reported outcomes. This trial will also evaluate the
effect of Serostim(R) 2mg administered on alternate days as a maintenance
therapy to sustain reductions in visceral adipose tissue attained during the
first 12 weeks of active therapy.
"This trial will build upon Serono's extensive experience with
Serostim(R)," said Paul Lammers, MD, MSc, Chief Medical Officer, Serono, Inc.
"We are hopeful that it will demonstrate the effectiveness of recombinant
human growth hormone for this metabolic complication of HIV."
The results of previous studies suggest that Serostim(R) may be an
effective treatment for this indication. Serono has previously reported
positive findings of the Serostim(R) for the Treatment of Adipose
Redistribution Syndrome (STARS) study, a double-blind, placebo-controlled
study, designed to evaluate Serostim(R) as a potential HARS therapy. The
study results showed that Serostim(R) 4mg administered daily for 12 weeks
decreased visceral adipose tissue and trunk fat as compared to placebo
(p<0.001). A significant decline in total and non-HDL cholesterol as compared
to placebo was also observed (p<0.005).
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 and may develop a fat pad of on the upper back
commonly known as a "buffalo hump."
About Serostim(R)
Serostim(R) [somatropin (rDNAorigin) 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 impaired glucose intolerance,
Type 2 diabetes mellitus and exacerbation of pre-existing 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.)(1) 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 over 30 projects in development.
In 2003, Serono achieved worldwide revenues of US$ 2,018.6 million, and a
net income of US$390 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.
SOURCE Serono International S.A.
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Related links:
http://www.serostim.com
CONTACT:
Serono in Geneva, Switzerland - Media
Relations, +41-22-739-36-00, Fax- +41-22-739-30-85, or Investor
Relations - +41-22-739-36-01, Fax - +41-22-739-30-22; or Serono,
Inc., Rockland, MA - Media Relations - +1-781-681-2486, Fax -
+1-781-681-2935, or Investor Relations - +1-781-681-2552, Fax -
+1-781-681-2912
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