Santhera Secures Exclusive Rights from NIH for a Novel Approach for the Treatment of Primary Progressive MS
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Santhera Secures Exclusive Rights from NIH for a Novel Approach for the
Treatment of Primary Progressive MS
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Liestal, Switzerland, June 6, 2013 -Santhera Pharmaceuticals (SIX: SANN)
announced today that it has obtained an exclusive license from the National
Institutes of Health (NIH) to its rights on a patent granted in the USA for the
use of idebenone for the treatment of primary progressive Multiple Sclerosis
(ppMS), a currently untreatable disease affecting about 40,000 patients in the
Unites States. The NIH is investigating the efficacy of Catena(®) (idebenone) in
ppMS in a placebo-controlled Phase II clinical trial.
Lead by the Neuroimmunology Branch of the National Institute of Neurological
Disorders and Stroke (NINDS), the NIH is investigating the efficacy of Catena(®)
(idebenone) in patients with ppMS in a double-blind, placebo-controlled Phase II
clinical trial (IPPoMS trial). Santhera is providing study medication under a
clinical trial agreement which gives Santhera the rights to the results.
Santhera has now obtained the exclusive rights to the use patent for idebenone
in ppMS granted in the USA. Patients who complete the IPPoMS trial can enter
into a 12-months open-label extension trial for which Santhera and the NIH
recently signed a Materials Cooperative Research and Development Agreement (M-
CRADA).
"Patients with ppMS do not respond to immunomodulatory therapies with proven
efficacy in relapsing remitting MS," said Bibiana Bielekova, M.D, the principal
investigator of the IPPoMS trial and Chief of the Neuroimmunology Disease Unit
at the NINDS. "Accumulating data indicate that mitochondrial dysfunction and
related oxidative stress may play a major role in the pathogenesis of
progressive MS. Idebenone enhances mitochondrial function and acts as an anti-
oxidant against membrane damage in laboratory models and is a rational treatment
choice in ppMS based on these pharmacological properties. Recruitment is
proceeding well in the IPPoMS trial and we are excited about the opportunity to
study the potential of idebenone in this currently untreatable disease."
"We are very enthusiastic about this collaboration and about the progress
currently being made. ppMS is a disease with high medical need. In contrast to
other forms of MS, there is currently no treatment option available for the
10-15 % of MS patients affected by this primary progressive subtype," commented
Nick Coppard, Santhera's Head of Development.
About primary progressive MS
Multiple Sclerosis (MS) is a chronic neurological disease of the central nervous
system affecting around 2.5 million people worldwide. Notable differences in MRI
findings can distinguish clinical subtypes of MS. The relapsing-remitting form
of MS (rrMS) is the most common form of the disease. Patients affected by rrMS
experience attacks of clinical worsening followed by periods of clinical
stability with partial or even complete recovery. So far, effective treatments
for rrMS are limited to immune-modulatory therapies which have not been proven
to be effective in ppMS patients. This subtype develops much slower than rrMS
but presents a steady functional decline without any distinct episodes of
regeneration or acute relapses. According to the MS Association of America
(MSAA) there are about 40,000 patients with ppMS living in the United States.
About idebenone and rationale for use in ppMS
Mitochondrial dysfunction together with aberrant formation of reactive oxygen
species are believed to underlie at least partially the development of
progressive CNS tissue destruction in ppMS. Idebenone, a synthetic short-chain
benzoquinone and a cofactor for the enzyme NAD(P)H:quinoneoxidoreductase (NQO1)
is capable of transferring electrons directly onto complex III of the
mitochondrial electron transport chain, thereby restoring cellular energy
levels. In addition, idebenone is a powerful anti-oxidant. In view of the
hypothesized involvement of mitochondrial dysfunction, and particularly the
reduced activity of the mitochondrial electron transport chain in patients
affected by ppMS, idebenone is a rational treatment choice for this disease
based on its pharmacological properties including its ability to cross the
blood-brain barrier.
About the IPPoMS trial
Adult ppMS patients up to 65 years of age with disability ranging from none to
moderately severe are eligible to enroll in the trial. This is a Phase I/II
safety/efficacy trial with an adaptive trial design: one year of pretreatment
baseline period serves the dual purpose of collecting patient-specific
biomarkers of disease progression and collecting longitudinal neuroimaging and
clinical data for selection of primary outcome measures. This baseline period is
then followed by a double-blind, idebenone (2250 mg/day) versus placebo
treatment phase for a total of 2 years. Additional information can be obtained
under www.clinicaltrials.gov (NCT00950248).
* * *
About the NINDS
The National Institute of Neurological Disorders and Stroke (www.ninds.nih.gov)
is the nation's leading funder of research on the brain and nervous system. The
NINDS mission is to reduce the burden of neurological disease - a burden borne
by every age group, by every segment of society, by people all over the world.
The National Institutes of Health, the nation's medical research agency,
includes 27 Institutes and Centers and is a component of the U.S. Department of
Health and Human Services. NIH is the primary federal agency conducting and
supporting basic, clinical, and translational medical research, and is
investigating the causes, treatments, and cures for both common and rare
diseases. For more information about NIH and its programs, visit www.nih.gov
About Santhera
Santhera Pharmaceuticals (SIX: SANN) is a Swiss specialty pharmaceutical company
focused on the development and commercialization of innovative pharmaceutical
products for the treatment of orphan neuromuscular and mitochondrial diseases,
areas of high unmet medical need with no current therapies. For further
information, please visit www.santhera.com.
Catena(®) is a trademark of Santhera Pharmaceuticals.
For further information, contact
Thomas Meier, Chief Executive Officer
Phone: +41 61 906 89 64
thomas.meier(at)santhera.com
Disclaimer / Forward-looking statements
This communication does not constitute an offer or invitation to subscribe for
or purchase any securities of Santhera Pharmaceuticals Holding AG. This
publication may contain certain forward-looking statements concerning the
Company and its business. Such statements involve certain risks, uncertainties
and other factors which could cause the actual results, financial condition,
performance or achievements of the Company to be materially different from those
expressed or implied by such statements. Readers should therefore not place
undue reliance on these statements, particularly not in connection with any
contract or investment decision. The Company disclaims any obligation to update
these forward-looking statements.
News release ppMS:
http://hugin.info/137261/R/1707174/565288.pdf
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Source: Santhera Pharmaceuticals Holding AG via Thomson Reuters ONE
[HUG#1707174]
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Datum: 06.06.2013 - 07:16 Uhr
Sprache: Deutsch
News-ID 267060
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