DEBIOPHARM TO CONTINUE BRAINZ STUDY WITH DEBIO 9902 SR.Debiopharm Group, Lausanne, Switzerland, a global independent biopharmaceutical development specialist focusing on serious medical conditions See carpal tunnel syndrome, computer vision syndrome, dry eyes and deep vein thrombosis. and particularly oncology, has announced that following a meeting of the independent Data Safety Monitoring Safety Monitoring of a clinical trial is conducted by an independent physician with relevant expertise. This is accomplished by review of adverse event, immediately after they occur, with timely follow-up through resolution. Board (DSMB DSMB Data & Safety Monitoring Board Clinical research A committee of independent clinical research experts who review data in ongoing clinical trials, ensuring that participants are not exposed to undue risk, and look for any differences in effectiveness ), the company received a recommendation to continue its Phase II BRAINz study with Debio 9902 SR (sustained release Sustained-release (SR), extended-release (ER, XR, or XL), time-release or timed-release, controlled-release (CR), or continuous-release (CR or Contin ) for the treatment of Alzheimer's disease Alzheimer's disease (ăls`hī'mərz, ôls–), degenerative disease of nerve cells in the cerebral cortex that leads to atrophy of the brain and senile dementia. (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 David Wilkinson may refer to:
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 huperzine A (hōōˑ·p (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, visit http://www.debiopharm.com or call 212/845-4272.