FLURIZAN™ & Alzheimer's Disease

FLURIZAN (tarenflurbil) is an investigational drug being studied in patients with mild Alzheimer's disease. It is a selective amyloid lowering agent (SALA) that reduces levels of the toxic peptide amyloid beta 42 (Aβ42) in cultured human cells and in animal models. [1,2]  Aβ42 is the primary initiator of neurotoxicity and amyloid plaque development in the brains of Alzheimer's disease patients.

FLURIZAN Highlights

• FLURIZAN is currently being studied in two Phase 3 clinical trials in patients with mild Alzheimer's disease.
• FLURIZAN has completed a Phase2 human clinical trial in 207 patients with Alzheimer's disease. (FLURIZAN Phase 2 Results Highlights)
• In clinical studies lasting up to four years, Flurizan has appeared safe and well tolerated.
• FLURIZAN is a selective amyloid beta 42 lowering agent (SALA).
• In nonclinical studies, FLURIZAN reduced the levels of the toxic peptide Aβ42 by approximately 70%, by modulating the action of gamma-secretase. (SALA Animation)
• Amyloid beta 42 (Aβ42) is a toxic peptide that kills neurons (brain cells) and initiates the formation of senile plaques in patients with Alzheimer's disease.
• Aβ42 is produced by an enzyme called gamma-secretase, during the processing of the Amyloid Precursor Protein (APP).
• APP is a protein that is important for normal brain function.

FLURIZAN Clinical Trials' Status

• US Phase 3, Fully Enrolled
  Last Patient, Last Visit: March, 2008
  The independent U.S. Phase 3 Alzheimer's Disease study Data Monitoring Committee (DMC), which has met regularly throughout the study, reviewed the safety data January 2008 and allowed the trial to continue without modification to the protocol.
  
  
• Global Phase 3, Fully Enrolled
  Last Patient, Last Visit: October 2008
  The independent Global Phase 3 Alzheimer's Disease study Data Monitoring Committee (DMC), which has met regularly throughout the study, reviewed the safety data December 2007 and allowed the trial to continue without modification to the protocol.

FLURIZAN Presentations

	Flurizan in AD: Efficacy and Safety in a 24 month Study (Wilcock) (Slides) August 25-28, 2007 European Federation of Neurological Societies (EFNS) 2007; Brussels, Belgium PDF, 227 KB
	Flurizan in AD: Delay to Psychiatric Events (Hendrix) (Poster) August 25-28, 2007 European Federation of Neurological Societies (EFNS) 2007; Brussels, Belgium PDF, 1.39 MB
	Flurizan in AD: A Responder Analysis (Zavitz) (Poster) August 25-28, 2007 European Federation of Neurological Societies (EFNS) 2007; Brussels, Belgium PDF, 162 KB
	Disease Modification in AD: A "Natural History Staggered Start" Analysis (Hendrix) (Poster) August 25-28, 2007 European Federation of Neurological Societies (EFNS) 2007; Brussels, Belgium PDF, 1.08 MB

References

1. Morihara T, Chu T, Ubeda O, Beech W, Cole GM. J Neurochem. 2002 Nov;83(4):1009-12. PMID: 12421374
2. Eriksen JL, Sagi SA, Smith TE, et al. J Clin Invest. 2003 Aug;112(3):440-9. PMID: 12897211 [Full Text]