Successful DSMB Review From Ongoing Phase II BRAINz Study
LAUSANNE, Switzerland, March 4 /PRNewswire/ -- Debiopharm Group (Debiopharm), a global independent biopharmaceutical development specialist focusing on serious medical conditions and particularly oncology, announced today that following a meeting of the independent Data Safety Monitoring Board (DSMB), the Company received a recommendation to continue its Phase II BRAINz study with Debio 9902 SR (sustained release) for the treatment of Alzheimer's disease (AD),without modification.
The DSMB's objective is to monitor the well being and safety of patients participating in a study and to review the safety data throughout its duration.
"This recommendation by the DSMB authorising Debiopharm to continue the BRAINz study confirms the safety profile of Debio 9902 SR" said David Wilkinson, from MARC, Moorgreen Hospital, Southampton, England and Principal Investigator in the United Kingdom, who presented this recommendation at the 10th International Hong Kong Springfield Symposium on Advances in Alzheimer Therapy.
About Debio 9902 SR
Debio 9902 SR is a novel AChE inhibitor which is administered once every 4 weeks. It is transformed non-enzymatically into its active compound, huperzine A (hup A). Hup A has been used in China for centuries to treat distinct disorders such as memory loss, schizophrenia and hypertension, and is widely used in North America and Europe as a food additive to enhance cognition and neuroprotection. The dual mode of action of Debio 9902 SR as a N-methyl-D-aspartate receptor antagonist and an AChE inhibitor, positions it as a third generation anti-Alzheimer's product by improving the general condition and cognitive functions of affected patients as well as having the potential of being a neuroprotectant. In addition, Debio 9902 SR once a month formulation aims to increase the benefit of the treatment by offering a better safety profile compared to already marketed AChE inhibitors, by increasing the compliance and -thus- the overall benefit for both the patients and their relatives.
About Debiopharm Group
Debiopharm Group is a global biopharmaceutical development specialist that in-licenses promising biologics and small molecule drug candidates. Debiopharm develops its products for global registration and maximum commercial potential for out-licensing to pharmaceutical partners for sales and marketing.
Debiopharm independently funds the worldwide development of all of its products while providing expertise in pre-clinical and clinical trials, manufacturing, drug delivery and formulation, and regulatory affairs.
Founded in 1979 and headquartered in Lausanne, Switzerland, Debiopharm
has developed three products with global combined sales in excess of $2.6
billion in 2006.
For more information on Debiopharm Group, please visit: http://www.debiopharm.com.
Debiopharm S.A. Contacts
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|SOURCE Debiopharm Group|
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