Santhera Joins EU-funded EndoStem Consortium in Preparation for Clinical Study with Omigapil in Congenital Muscular Dystrophies
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Santhera Joins EU-funded EndoStem Consortium in Preparation for Clinical Study
with Omigapil in Congenital Muscular Dystrophies
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Liestal, Switzerland, April 11, 2012 - Santhera Pharmaceuticals (SIX: SANN)
announced today its participation in the EndoStem Consortium, a pan-European
partnership of 15 academic and industry teams. EndoStem is co-funded by the
European Union and seeks to accelerate the development of effective therapies
for muscular dystrophies. In collaboration with the consortium, Santhera will
conduct a Phase I study with its compound omigapil in Congenital Muscular
Dystrophies. These severe, genetically determined neuromuscular diseases
frequently affect children with life-threatening progressive muscle weakness.
EndoStem is an academic and industry partnership of research and clinical teams
and includes partners in six European countries. The consortium's main goals are
to conduct clinical trials in muscular dystrophies using innovative
biopharmaceuticals with highly specific and well-defined modes of action.
EndoStem is co-funded by the European Commission under the 7th Framework
Programme and is coordinated by Professor David Sassoon, Institut de Myologie at
the Pierre and Marie Curie University in Paris, France.
As part of the program, Santhera will develop a novel formulation of omigapil
and support the planning and conduct of an ascending multiple-dose Phase I
study. The open-label, 12-week clinical trial will determine the
pharmacokinetic, safety and tolerability profile of omigapil in children. In
addition, the study will assess the feasibility and procedures for future
efficacy trials in this patient population. Study centers will be the Dubowitz
Neuromuscular Centre, Institute of Child Health of the University College
London, UK, and the National Institute of Neurological Disorders and Stroke of
the National Institutes of Health in Bethesda, MD, US. The study is supported by
Cure CMD, a dedicated patient advocacy group whose mission is to bring research,
treatments and, in the future, a cure for Congenital Muscular Dystrophies. The
start of patient enrollment is expected during the second half of 2012.
"We look forward to working closely with Santhera in preparation of this
clinical study with omigapil in Congenital Muscular Dystrophies. Santhera's
participation in the EndoStem program is based on their focus and expertise in
advancing drug candidates through preclinical and clinical development in
muscular dystrophies," said David Sassoon, the coordinator of the EndoStem
Consortium. "EndoStem has ambitious goals to coordinate this pan-European
partnership of 15 research and clinical teams from academia, biotech and
pharmaceutical companies. We aim at accelerating the translation of research
into the clinical development of new therapies."
"Santhera's inclusion in this program reflects both our scientific and clinical
expertise in this special therapeutic area," said Thomas Meier, Chief Executive
Officer of Santhera. "We will support the consortium by developing and supplying
a formulation for omigapil that is suitable for use in children with Congenital
Muscular Dystrophies. The planned study will determine the pharmacokinetic
profile of omigapil, determine adequate drug dosing in this vulnerable patient
population and assess procedures for further efficacy trials."
About Congenital Muscular Dystrophies
Congenital Muscular Dystrophies refer to a wide variety of inherited
neuromuscular conditions characterized by different forms of progressive loss of
muscle tissue. Severe forms can affect newborns or young children with life-
threatening progressive muscle weakness ("floppy infant syndrome").
Complications associated with the disorder cause immobility at young age and
early mortality. Patients suffer from loss of body weight, skeletal deformations
and respiratory distress resulting in immobility at young age and early
mortality. No pharmacological therapy is currently available or in advanced
clinical development. Treatment options are confined to ventilatory support and
orthopedic surgery for scoliosis as well as supplementary nutrition to avoid
malnutrition.
About Omigapil
Omigapil is a deprenyl analog and has anti-apoptotic properties. Originally
developed by Novartis, Santhera obtained an exclusive license to develop the
molecule in Congenital Muscular Dystrophies. Nonclinical studies in a disease-
relevant model showed that omigapil inhibits cell death and reduces body weight
loss and skeletal deformation while increasing locomotive activity and
protecting from early mortality [1].
About EndoStem
EndoStem (www.endostem.eu) is a partnership of 15 research and clinical teams
from globally recognised academic centres, small biotech and large
pharmaceutical companies working together to develop new strategies aimed at
stimulating stem cells that are resident in damaged tissue to repair it in situ.
This approach is recognised as one of the most promising approaches to targeting
stem cells for regenerative medicine due to the alignment with existing
therapeutic development approaches used by large industry and recent advances in
understanding the key barriers for tissue regeneration. Coordinated by Professor
David Sassoon, cofinanced by the European Commission via the 7th Framework
Programme the aims of the project over are: (i) the implementation of clinical
trials, with muscular dystrophies as the primary clinical target using
innovative biopharmaceuticals; (ii) the development of novel best in class
biopharmaceuticals with highly specific and well defined modes of action; (iii)
the fast-track clinical translation based on a constant feedback loop between
emerging patient responsiveness to new drugs and the development of the next
generation of therapeutics; and (iv) the better understanding of the key issues
preventing effective tissue repair matched with approaches to circumvent them.
Reference
[1] Erb M. et.al. (2009). Omigapil ameliorates the pathology of muscle dystrophy
caused by laminin-alpha 2 deficiency. Journal of Pharmacology and Experimental
Therapeutics 331: 787-795
* * *
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 with no current therapies. Santhera's first product
Catena® is currently marketed in Canada to treat Friedreich's Ataxia. Catena® is
also under review for marketing authorization by the European Medicine Agency as
the first therapy for patients suffering from Leber's Hereditary Optic
Neuropathy. For further information, please visit www.santhera.com.
Catena® is a trademark of Santhera Pharmaceuticals.
For further information, contact
Santhera Pharmaceuticals:
Thomas Meier, Chief Executive Officer
Phone: +41 61 906 89 64
thomas.meier(at)santhera.com
Thomas Staffelbach, Vice President, Head Public & Investor Relations
Phone: +41 61 906 89 47
thomas.staffelbach(at)santhera.com
EndoStem:
Jonathan Dando, Consortium Manager
Phone +33 6 225 418 20
dandojonathan(at)hotmail.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 EndoStem:
http://hugin.info/137261/R/1601106/505479.pdf
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Source: Santhera Pharmaceuticals Holding AG via Thomson Reuters ONE
[HUG#1601106]
Unternehmensinformation / Kurzprofil:
Datum: 11.04.2012 - 07:00 Uhr
Sprache: Deutsch
News-ID 133672
Anzahl Zeichen: 9670
contact information:
Town:
Liestal
Kategorie:
Business News
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