GENEVA, November 17, 2010 /PRNewswire/ -- Merck Serono, a
division of Merck KGaA, Darmstadt, Germany, announced today the completion of
patient enrollment in the ORACLE MS 1 clinical study. This
randomized, double blind, placebo-controlled, international Phase
III trial is designed to evaluate the therapeutic effects of
Cladribine Tablets on the time to conversion to multiple sclerosis
(MS) in people with a first clinical event suggestive of the
disease. A total of 617 patients considered at high risk of
developing MS due to a recently experienced isolated demyelinating
event and having magnetic resonance imaging (MRI) brain scans
consistent with early signs of MS were randomized in the study.
"The clinical development program of Cladribine Tablets is
designed to characterize the potential therapeutic effects of
Cladribine Tablets therapy at the various stages of multiple
sclerosis," said Dr. Bruno Musch,
Merck Serono's Head of Global Clinical Development
Neurodegenerative Diseases. "The completion of patient enrollment
in the ORACLE MS study is a significant milestone as this study
will provide insight on the impact of Cladribine Tablets therapy on
the course of multiple sclerosis when administered early in the
disease process."
Besides the ORACLE MS study, the Phase III program of Cladribine
Tablets includes the completed CLARITY 2 study and the ongoing
CLARITY EXTENSION study in patients with relapsing-remitting MS.
Cladribine Tablets were recently approved in Australia and Russia as a treatment of relapsing-remitting
MS, under the brand name Movectro(R), and are under regulatory
review in other countries. Registration applications for Cladribine
Tablets as a treatment for relapsing-remitting MS are supported by
the results from the CLARITY study.
1 ORACLE MS: ORAl CLadribine in Early MS
2 CLARITY: CLAdRIbine Tablets treating MS orallY
ORACLE MS study design
The ORACLE MS study is a two-year (96-week), randomized,
double-blind, placebo-controlled, international trial. It
randomized 617 patients considered at risk of developing MS due to
a recently experienced isolated demyelinating event (e.g. optic
neuritis, myelopathy or brainstem syndrome) and having MRI brain
scans consistent with early signs of MS. Study participants were
randomized to one of three different treatment groups consisting of
two different dose regimens of Cladribine Tablets or matching
placebo tablets (1:1:1 ratio).
Patients will be treated for a period of two years (96 weeks),
or up to the time when they experience a second attack leading to a
diagnosis of clinically definite MS, in which case they would be
offered open-label treatment with Rebif(R) 44 mcg three times a
week for a 96-week maintenance treatment period. Patients who do
not convert to clinically definite MS within the initial 96-week
period of the study will be eligible to enroll in a 96-week
long-term follow-up treatment period. These maintenance and
long-term follow-up periods of the study are intended to assess the
effect of early treatment with Cladribine Tablets on relapses and
subsequent treatment response to disease-modifying therapy for
relapsing-remitting MS and to evaluate the sustained effect of
Cladribine Tablets in delaying the development of definite MS.
In the study, Cladribine Tablets are given in two (3.5 mg/kg
total dose) or four (5.25 mg/kg total dose) treatment courses in
the first year, with each course consisting of once daily
administration for four to five consecutive days (depending on
patient weight), which means study patients take Cladribine Tablets
for only 8 to 20 days during the first year. In the second year,
two treatment cycles are administered to both patient groups
receiving Cladribine Tablets, meaning that patients take Cladribine
Tablets for 8 to 10 days during the second year.
The primary endpoint of the ORACLE MS study is time to
conversion to clinically definite MS, according to the Poser
criteria, defined by either a second attack, or a sustained
increase in EDSS. Other endpoints include time to conversion to MS
according to the McDonald criteria (the main secondary endpoint),
assessments of MRI brain scans, and disability progression.
About Cladribine Tablets
Merck Serono's oral formulation of cladribine (Cladribine
Tablets) is an investigational treatment for patients with
relapsing forms of multiple sclerosis (MS). Cladribine is a small
molecule that may interfere with the behavior and the proliferation
of certain white blood cells, particularly lymphocytes, which are
thought to be involved in the pathological process of MS.
Cladribine Tablets were approved in Russia in July
2010 and in Australia in
September 2010 as a treatment of
relapsing-remitting MS and are under regulatory review in other
countries.
The clinical development program for Cladribine Tablets
includes:
- The CLARITY (CLAdRIbine Tablets treating MS orallY) study and its
extension: a two-year Phase III placebo-controlled trial designed to
evaluate the efficacy and safety of Cladribine Tablets as a monotherapy
in patients with relapsing-remitting MS and the CLARITY EXTENSION
two-year Phase III study designed to provide data on the long-term
safety and efficacy of extended administration of Cladribine Tablets for
up to four years.
- The ORACLE MS (ORAl CLadribine in Early MS) study: a two-year Phase
III placebo-controlled trial designed to evaluate the efficacy
and safety of Cladribine Tablets as a monotherapy in patients at risk of
developing MS (patients who have experienced a first clinical event
suggestive of MS). This trial was announced in September 2008.
- The ONWARD (Oral Cladribine added oN to interferon beta-1a in patients
With Active Relapsing Disease) study: a Phase II placebo-controlled
trial designed primarily to evaluate the safety and tolerability of
adding Cladribine Tablets treatment to patients with relapsing forms of
MS, who have experienced breakthrough disease while on established
interferon-beta therapy. This trial was announced in January 2007.
- The PREMIERE (PRospective observational long-term safEty registry of
Multiple sclerosis patIEnts who have participated in CladRibinE clinical
trials) registry: an eight-year observational safety registry of patients
who have participated in Cladribine Tablets clinical trials, designed to
support the evaluation of the long-term safety of Cladribine Tablets in
MS.
About multiple sclerosis
Multiple sclerosis (MS) is a chronic, inflammatory condition of
the central nervous system and is the most common, non-traumatic,
disabling neurological disease in young adults. It is estimated
that approximately two million people have MS 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.
About Merck Serono
Merck Serono is the division for innovative prescription
pharmaceuticals of Merck KGaA, Darmstadt, Germany, a global pharmaceutical and chemical
company. Headquartered in Geneva,
Switzerland, Merck Serono discovers, develops, manufactures
and markets innovative small molecules and biopharmaceuticals to
help patients with unmet medical needs. In the United States and Canada, EMD Serono operates through separately
incorporated affiliates.
Merck Serono has leading brands serving patients with cancer
(Erbitux(R), cetuximab), multiple sclerosis (Rebif(R), interferon
beta-1a), infertility (Gonal-f(R), follitropin alfa), endocrine and
metabolic disorders (Saizen(R) and Serostim(R), somatropin),
(Kuvan(R), sapropterin dihydrochloride) as well as cardiometabolic
diseases (Glucophage(R), metformin), (Concor(R), bisoprolol),
(Euthyrox(R), levothyroxine). Not all products are available in all
markets.
With an annual R&D expenditure of more than EUR 1 billion, Merck Serono is committed to
growing its business in specialist-focused therapeutic areas
including neurodegenerative diseases, oncology, fertility and
endocrinology, as well as new areas potentially arising out of
research and development in autoimmune and inflammatory
diseases.
About Merck
Merck is a global pharmaceutical and chemical company with total
revenues of EUR 7.7 billion in 2009,
a history that began in 1668, and a future shaped by approximately
40,000 (including Merck Millipore) employees in 64 countries. Its
success is characterized by innovations from entrepreneurial
employees. Merck's operating activities come under the umbrella of
Merck KGaA, in which the Merck family holds an approximately 70%
interest and free shareholders own the remaining approximately 30%.
In 1917 the U.S. subsidiary Merck & Co. was expropriated and
has been an independent company ever since.
For more information, please visit http://www.merckserono.com or
http://www.merck.de
http://www.merckserono.com
Merck Serono is a division of Merck.