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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
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