Serono Announces Initiation of the Reflex Trial to Evaluate New Formulation of Rebif(R) in Patients at Risk of Developing Multip
December 12 2006 - 1:00AM
PR Newswire (US)
First Trial Assessing Therapeutic Benefit of Two Different Dosage
Regimens of Disease Modifying Therapy in People With First Clinical
Symptoms Suggesting Multiple Sclerosis GENEVA, Switzerland,
December 12 /PRNewswire-FirstCall/ -- Serono (virt-x: SEO and NYSE:
SRA) announced today the initiation of a Phase III clinical trial
to evaluate the effect of two dosage regimens of the new
formulation of Rebif(R) (interferon beta-1a 44 mcg, three times a
week or once a week) on the time to conversion to multiple
sclerosis (MS) in people with first clinical symptoms suggestive of
the disease. The trial, called the REFLEX study (REbif FLEXible
dosing in early MS), will involve 480 patients considered at risk
of developing MS because of a recently experienced isolated
demyelinating event and of typical magnetic resonance imaging (MRI)
brain scans. "It has been demonstrated that early treatment with
interferon-beta can reduce the risk of developing multiple
sclerosis. Optimizing the impact of such treatment on development
of irreversible neurological damage and ascertainment of long term
outcomes is still subject of active experimental and clinical
research", said Professor Ludwig Kappos, from the Department of
Neurology, University Hospital Basel, Switzerland, and a member of
the Steering Committee of the REFLEX study. "The REFLEX study will
determine the respective therapeutic benefit of two different
dosage regimens of the new formulation of Rebif(R) for people at
risk of developing multiple sclerosis." The REFLEX study is a
randomized, double-blind, placebo-controlled, multicenter trial.
Study participants will receive either the new formulation of
Rebif(R) 44 mcg three times a week (160 patients), or the new
formulation of Rebif(R) 44 mcg once a week (160 patients), or
placebo (160 patients) as a subcutaneous injection for a period of
24 months, unless they suffer from a second attack leading to a
diagnosis of clinically definite MS. In this case, patients will be
offered open label treatment with the new formulation of Rebif(R)
44 mcg three times a week. The primary endpoint of the study is
time to conversion to MS, according to the McDonald criteria. Other
endpoints will include assessments of MRI brain scans, clinical
relapses and disability progression. The REFLEX study will also
evaluate the effect of the new formulation of Rebif(R) on cognitive
function as measured by the Paced Auditory Serial Addition Test
(PASAT)[1]. Cognitive dysfunction can occur early in MS and impact
memory, ability to process information and learning. A sub-study
will assess retinal nerve fiber thickness (a marker of axonal loss)
by means of optical coherence tomography (OCT). This sub-study will
be conducted in selected centers, equipped with this leading edge
technology. In addition, the REFLEX study will aim at identifying
genetic/genomic profiles associated with disease and treatment
outcomes. The new formulation of Rebif(R) has been developed by an
innovative approach, using state-of-the-art technologies. It is
under regulatory review by the European Medicines Agency, the US
Food and Drug Administration and other healthcare authorities, and
is not currently approved. About Rebif(R) Rebif(R) (interferon
beta-1a) is a disease-modifying drug used to treat relapsing forms
of multiple sclerosis (MS) and is similar to the interferon beta
protein produced by the human body. Interferon helps modulate the
body's immune system, fight disease and reduce inflammation.
Rebif(R), which was approved in Europe in 1998 and in the US in
2002, is registered in more than 80 countries worldwide. In the
United States, Rebif(R) is co-marketed by Serono, Inc. and Pfizer
Inc. Rebif(R) has been proven to delay the progression of
disability, reduce the frequency of relapses and reduce MRI lesion
activity and area[2]. Rebif(R) is not approved for treatment of
chronic progressive MS. Rebif(R) is available in a 22 mcg and 44
mcg ready-to-use pre-filled syringe and a titration pack, and can
be stored at room temperature for up to 30 days if a refrigerator
is not available. Most commonly reported side effects are injection
site disorders, flu-like symptoms, elevation of liver enzymes and
blood cell abnormalities. Patients, especially those with
depression, seizure disorders, or liver problems, should discuss
treatment with Rebif(R) with their doctors. About Serono and
multiple sclerosis In addition to Rebif(R), Serono also offers a
second therapy within its US portfolio of multiple sclerosis (MS)
therapies: Novantrone(R) (mitoxantrone for injection concentrate)
for worsening forms of MS. Full prescribing information for these
products can be obtained by contacting Serono or visiting the
Serono website. Additional therapeutic options are currently under
development at Serono, including oral cladribine, currently in
Phase III studies and potentially the first oral therapy for
treatment of MS, as well as several products in early stage
development including: osteopontin, an MMP-12 inhibitor, a JNK
inhibitor and interferon beta:Fc. Serono also is taking a leading
role in developing an understanding of the role of genetics in MS,
with a whole genome scan currently underway. About multiple
sclerosis Multiple sclerosis (MS) is a chronic, inflammatory
condition of the nervous system and is the most common,
non-traumatic, neurological disease in young adults. MS may affect
approximately two million people worldwide. While symptoms can
vary, the most common symptoms of MS include blurred vision,
numbness or tingling in the limbs and problems with strength and
coordination. The relapsing forms of MS are the most common.
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Forward-looking statements 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 February 28, 2006. 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, the outcome of any
government investigations and litigation. Serono is providing this
information as of the date of this press release, and 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. About Serono Serono is a
global biotechnology leader. The Company has eight biotechnology
products, Rebif(R), Gonal-f(R), Luveris(R), Ovidrel(R)
/Ovitrelle(R), Serostim(R), Saizen(R), Zorbtive(TM) and Raptiva(R).
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, including oncology and
autoimmune diseases. In 2005, Serono, whose products are sold in
over 90 countries, achieved worldwide revenues of US$2,586.4
million. Reported net loss in 2005 was US$106.1 million, reflecting
a charge of US$725 million taken relating to the settlement of the
US Attorney's Office investigation of Serostim. Excluding this
charge as well as other non-recurring items, adjusted net income
grew 28.4% to US$565.3 million in 2005. 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). For more information, please contact Corporate
Media Relations: Tel: +41-22-414-36-00 Fax: +41-22-414-30-85
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SEO.VX / SRA.N Bloomberg: SEO VX / SRA US Investor Relations, USA:
Tel: +1-781-681-2552 Fax: +1-781-681-2912 [1] The PASAT is a
measure of cognitive function that assesses auditory information
processing speed (the ability to attend to orally presented
information, process the information in memory, and then formulate
a response in a timely fashion) and flexibility, as well as
calculation ability. [2] The exact correlation between MRI findings
and the current or future clinical status of patients, including
disability progression, is unknown. DATASOURCE: Serono
International S A CONTACT: For more information, please contact
Corporate Media, Relations: Tel: +41-22-414-36-00, Fax:
+41-22-414-30-85, http://www.serono.com/; Media Relations, USA:
Tel: +1-781-681-2340, Fax: +1-781-681-2935,
http://www.seronousa.com/; Corporate Investor Relations: Tel:
+41-22-414-36-01, Fax: +41-22-414-30-22, Reuters: SEO.VX / SRA.N,
Bloomberg: SEO VX / SRA US; Investor Relations, USA:, Tel:
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