UBI has been developing an immunotherapeutic vaccine for Alzheimer's Disease (AD), the degenerative brain disorder that primarily affects the elderly. The UBI vaccine employs the UBITh® helper T cell technology and a particular site-specific epitope to target the amyloid-beta peptide (AŁ]). AŁ] accumulates in the brain as deposits of insoluble AŁ] fibrils. Extensive neuropathological and genetic data from humans and mouse models link the over-production and deposition in the brain of AŁ] as the initiating cause for AD. Presently, compounds targeting AŁ] are the most promising therapies for AD.
The recent study of an immunotherapeutic vaccine directed against AŁ], sponsored by Elan and Wyeth, produced dramatic results showing that the vaccine preserved cognitive faculties in AD patients. However, the Elan/Wyeth trial had to be discontinued due to complications (Schenk D., et al, 2004). UBI decided to give its own AD program the highest priority in consideration of the safety and potency of its own peptide vaccine technologies. Moreover, UBI is convinced of the novelty of its UBITh® AD immunotherapeutic and believes we have the technology necessary to produce a safe and effective peptide-based AŁ] vaccine.
UBI has obtained corporate sponsorship for clinical trials of the UBITh® AD immunotherapeutic vaccine in China. The IND application has been submitted to the SFDA (China). UBI anticipates an accelerated regulatory approval in China once safety and efficacy are established in Phase I and II clinical trials, followed by entry into the China market in 2008 or earlier. IND applications are to follow in Taiwan and the US.
Related Alzheimer's Disease Websites.
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