Re: Serono Announces Completion of Patient Enrollment in Phase III Trial of Serostim

[Guest guest]

Although the Serono national trial has completely enrolled, you can

still get into a Growth Hormone trial if you can make into Boston

approximately once per month.

They are still enrolling patients for this study in Boston:

HIV Positive Volunteers with Lipodystrophy Needed

HIV positive subjects age 18-65 with changes in body fat distribution

are needed for a three-year research study investigating treatment

with growth hormone. Participants will self-inject growth hormone

for 18 months and placebo for 18 months. Participation in this study

requires an initial screen visit, and, if you qualify, 17 outpatient

visits over 3 years. Compensation up to $500 is provided. For more

information call Dr. Polyxeni Koutkia at , Program in

Nutritional Metabolism, Massachusetts General Hospital.

IRB Protocol: 2002P-001170

---------------------------

In PozHealth , GetWell@... wrote:

>

> http://biz.yahoo.com/prnews/050124/ukf014_1.html

>

> Serono Announces Completion of Patient Enrollment in Phase III

Trial of

> Serostim® (Somatropin [rDNA Origin] for Injection) in HIV-

Associated Adipose

> Redistribution Syndrome (HARS)

>

> Monday January 24, 1:00 am ET

>

> GENEVA, Switzerland and ROCKLAND, Massachusetts, January 24

>

> /PRNewswire-FirstCall/ -- Serono Inc., the US affiliate of global

> biotechnology leader Serono (virt-x: SEO and NYSE: SRA), announced

today that

> it has completed enrollment in its second multi-center, phase III

trial of

> Serostim® (somatropin [rDNA origin] for injection) in the

treatment of

> HIV-Associated Adipose Redistribution Syndrome (HARS).

> The primary goal of this randomized, double-blind, placebo-

controlled trial

> is to assess whether Serostim induction therapy significantly

reduces the

> marked abnormal accumulation of visceral adipose tissue (intra-

abdominal fat) and

> fat maldistribution which characterize HARS, and whether low-dose

> maintenance therapy prevents the abnormalities from returning

during a continued course

> of therapy.

> " We are pleased to have reached this major milestone for this very

important

> study, " said Sapirstein, Executive Vice President of

Metabolic

> Endocrinology at Serono, Inc. " An unmet need clearly exists in this

patient

> population. Serono is committed to ensuring rapid completion of the

trial and a US

> registration submission for Serostim as a treatment for this

orphan

> indication. "

> " More than 300 patients were enrolled in the study in only six

months. The

> dedication of the clinical investigators, all study site personnel

and our

> in-house study team coupled with the need and enthusiasm for this

project in the

> HIV community led to speedy enrollment of this study, " said

Lammers,

> Chief Medical Officer at Serono, Inc. " The results of this pivotal

Phase III

> clinical trial are eagerly awaited. "

> 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®

> Serostim [somatropin (rDNAorigin) for injection] is the only growth

hormone

> approved by the US Food and Drug Administration for the treatment

of HIV

> 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, e.g.,

> glucose intolerance.

> 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_ (http://www.serostim.com/) .

> About Serono

> is a global biotechnology leader. The Company has eight

biotechnology

> products, Rebif®, Gonal-F®, Luveris®, Ovidrel(R )/Ovitrelle®,

Serostim®, Saizen®,

> Zorbtive and Raptiva®. In addition to being the world leader

in

> reproductive health, Serono has strong market positions in

neurology, metabolism and

> growth and has recently entered the psoriasis area. 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.

> _http://www.serono.com_ (http://www.serono.com/) Reuters:

SEO.VX /

> SRA.N

>

> Bloomberg: SEO VX / SRA US

>

>

>

> _http://biz.yahoo.com/prnews/050124/ukf014_1.html_

> (http://biz.yahoo.com/prnews/050124/ukf014_1.html)