TOKYO, Nov. 27 /CNW/ - Sosei Group Corporation ("Sosei"; TSE Mothers
Index: 4565), a biopharmaceutical company, today announces an update on the
status of its collaborative project SD118, which is under development for the
treatment of neuropathic pain. SD118 has commenced a multiple dose ascending
Phase I study and the initial single ascending dose Phase I study to explore
higher doses has been extended.
SD118 is being jointly developed with NeuroDiscovery Ltd (ASX Code: NDL)
and its wholly owned subsidiary NeuroSolutions Ltd under a Collaboration
Agreement concluded in June 2006. SD118 was previously under investigation in
Japan for a different indication and now, following re-profiling and
evaluation in experimental animal models, has demonstrated its potential as a
new oral therapy for neuropathic pain.
The latest study is a double blind, placebo controlled, multiple dose,
sequential group, dose escalation trial in healthy male volunteers to assess
the safety, tolerability and pharmacokinetic profile of SD118 administered as
an oral capsule. The study, involving some 36 subjects in 4 cohorts, is being
conducted in a single centre in the UK under a CTA (Clinical Trial
Authorisation) regulatory approval.
Additionally, in recognition of the drug's emerging positive safety
profile and the successful completion of the original trial protocol, it has
been decided to extend the previously announced single dose Phase I study to
explore additional higher doses. Regulatory approval has been obtained for
this trial extension. A further announcement will be made when the extension
phase is completed and all the study results are fully analysed.
Mr Shinichi Tamura, President & CEO of Sosei, said: "I am delighted that
clinical development of SD118 continues to make good progress. This project
has the potential to provide a valuable addition to currently available
therapies in an area of notable unmet medical need."
Notes for Editors:
About Neuropathic Pain
Neuropathic pain refers to pain related to peripheral or central nervous
system injury and can persist for months or years after the initial insult.
The condition has a poor prognosis and is a significant cause of morbidity.
The neuropathic pain market is forecast to reach US$5.5 billion by 2010.
Although there is no single definition of neuropathic pain, approximately
26 million patients worldwide suffer from some form of the condition
(Espicom, 2005). As the currently available treatments for neuropathic pain
provide only partial pain relief, there is a strong need for new agents with
novel mechanisms of action that lead to improved drugs.
Sosei Group Corporation is a leading international biopharmaceutical
company with significant expertise in product discovery and development. It
has established a reduced risk business model primarily upon identifying new
uses for established drugs and exploiting its unique position within Japanese,
European and North American pharmaceutical markets by acquiring compounds
from, and bringing compounds into, Japan.
For further information about Sosei, please visit http://www.sosei.com
NeuroDiscovery Ltd is an ASX listed neurology research and development
company which owns 100% of NeuroSolutions Ltd (ASX Code: NDL).
For further information visit http://www.neurodiscoveryltd.com.
NeuroSolutions Limited is a profitable service company, applying its
broad expertise and drug discovery platforms to become a leading provider of
specialised electrophysiological assays to the biopharmaceutical industry.
Electrophysiology is a specialised technique which is used to record
electrical activity in membranes, cells, tissues or in vivo. NeuroSolutions
current clients include many other established pharmaceutical and
In parallel to running its service business, the Company is also
exploiting its in-house technologies and expertise for its own internal R&D
and has a mature pipeline of programmes underway for the treatment of pain.
During 2007 the Company has commenced Phase I trials on its lead compound
NSL-043 in partnership with Sosei Group Corporation, a listed Japanese
biopharmaceutical company. In addition Phase II trials for its other lead
programme NSL-101 have commenced to explore its utility in dental pain.
For further information visit http://www.nsolns.com.
For further information:
For further information: Sosei Group Corporation: Hiroki Maekawa,
Representative Executive Officer, E-mail: email@example.com, Tel:
+81-3-5210-3399, Fax: +81-3-5210-3291; Sosei R&D Ltd: John DAFFURN, EVP
Corporate Development, E-mail: firstname.lastname@example.org, Tel: +44(0)1799-532-350,
Fax: +44(0)1799-532-351; The Trout Group: Seth Lewis, Tel: (617) 583-1308;
Brandon Lewis, Tel: (646) 378-2931; NeuroDiscovery Ltd: Tel:
+61(0)408-994-313, David McAuliffe, Executive Director, E-mail:
email@example.com; Talk Biotech: Tel: +61(0)422-206-036, Fay Weston,