Tarenflurbil (Flurizan): A Promising Alzheimer's Disease Treatment Drug

Alzheimer's disease is a degenerative brain disorder, first discovered by German physician Alois Alzheimer in 1906, and seventh leading cause of death in the United States. Since the discovery of this disease, researchers have learned how this form of dementia (Decline of cognitive function more than expected from normal aging in geriatric population 2) progresses, leading to loss of memory, impairment to think and loss of bodily function. 1 Early stage of the disease includes short term memory loss, which is often hard to diagnose and predominantly occurs in people over the age of sixty-five years old. Later stage of the disease; symptoms include anger, confusion, mood swings, language breakdown, until death occurs. Estimate duration of the Alzheimer's disease five to twenty years. Alzheimer's disease is eighty percent linked to genetic factors. 4 "Approximately four million Americans have this disease and some
14 million are expected to have it by 2050 unless a cure or preventive treatment is found". 3

Researchers (Weill Cornell Medical College and Columbia University College of Physicians Surgeons 5) discovered the cause of Alzheimer's disease attributed to accumulation of amyloid plaques in the brain, which is a Beta-amyloid protein component. 3 Eventually the plaques in the brain kill nerve cells foundation of memory loss, personality changes, and neurological changes linked to Alzheimer's disease. 5 Evidence supporting the conclusion Alzheimer's disease is linked to accumulation of amyloid plaques in the brain, confirmed by disease prone mouse study, conducted by John Disterhoft of the Feinberg School of Medicine at Northwestern University, Chicago and colleagues. 6

Myriad Genetics (public traded company- symbol MYGN) conducting largest clinical studies, determine if the drug Tarenflurbil (generic name Flurizan) effectively will treat Alzheimer's disease. On March 5, 2007 Myriad reported final results of phase two clinical trial 711 Myriad Genetics stated regarding administration of high-dose Flurizan 800 milligrams twice daily: "demonstrated a substantial benefit over other dose groups in the study and that this benefit continued to increase over 24 months, for each of the evaluated areas of cognition, memory loss, global function and activities of daily living". 12 Flurizan subjects taking 800 mg experienced a 60% reduction in psychiatric events, including agitation, aggression, confusional state and depression. 13 The findings of the clinical study published in The Lancet Neurology (April 2008) which recommends a phase three study of the drug Tarenflurbil. "Tarenflurbil reduces production of 42 - amino acid peptide (selective amyloid lowering agent (SALA) 9), which is believed to initiate brain damage characteristic of Alzheimer's disease". The 42 amino acid peptide primary initiator amyloid plaques development in the brain and neurotoxicity linked to Alzheimer's disease patients. 9 Common side effects included dizziness, diarrhea, and nausea. 8: 210 patients with mild to moderate Alzheimer's in Canada and United Kingdom received tanenflurbil 800 mg or 400 mg twice daily or placebo for twelve months. Researchers lead by Dr. Gordon K. Wilcock from Radcliffe hospital, University of Oxford, in the United Kingdom noted as result of phase two clinical trial: Cognitive decline was in the right direction.

Global Phase Three study of Tarenflurbil during an 18 months of dosing, evaluate change in cognitive ability and activities of daily living in patients with Alzheimer's disease (AD). 10 According to Dr. Wilcock phase three study will encompass to treat more than 2000 patients in total. 11 The locations of the study will take place: Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, United Kingdom and United States (130 centers 13). A certain number of patients will be taking a placebo compared to taking Flurizan. "Subjects may be taking approved medication for Alzheimer's disease provided the dose has been stable for at least 6 months." 10 As a result of phase two trial study, subjects well tolerated Tarenflurbil 800-mg twice daily dose, should be used in phase three trials. 11 Myriad Genetics will let the trial run through the first half of 2008 until completion. 12 After the completion of the study, some patients may be eligible to take Flurizan under an open- label protocol. 10 Requirements of the European Medicines Agency for marketing approval of Flurizan in Europe based upon successful results of phase three study. 14 Also, phase three study is the last stage before Food and Drug Administration (USA) consideration for granting approval for sale. 15 More information is available by email: alzheimerstrials@myriad.com10 Participants interested in Phase Three study should call (888) 459 - 4888. 13

Caution should be considered before Flurizan is prescribed. "A drug may be safe when given on its own, but if someone is taking multiple medications (especially elderly), you run the risk of a drug interaction." 15 Tarenflurbil is competing against rival Neurochem's Alzhemed drug, become the first Alzheimer's disease modifying therapy to market. 16 However, reported in August 2007, Neurochem's Alzhemed failed a late stage trial for Alzheimer's. 17

References:

1) What is Alzheimer's? - http://www.alz.org/alzheimers_disease_what_is_alzheimers.asp

2.) Dementia - http://en.wikipedia.org/wiki/Dementia

3.) Lowering - Beta-Amyloid Levels in Blood to Treatment Alzheimer's - http://www.sciencedaily.com/releases/2003/01/030108071621.htm

4.) Alzheimer's disease - http://en.wikipedia.org/wiki/Alzheimers

5.) Researchers Discover Possible Way Beta-Amyloid Protein Kills Nerve Cell in Brains Affected by Alzheimer's Disease - http://www.nyp.org/news/hospital/220.html

6.) Amyloid beta protein may trigger Alzheimer's - http://www.medicalnewstoday.com/articles/5222.php

7.) Tarenflurbil - http://en.wikipedia.org/wiki/R-flurbiprofen

8.) Experimental Drug Eases Symptoms of Mild Alzheimer's - http://news.yahoo.com/s/hsn/20080430/hl_hsn/experimentaldrugeasessymptomsofmildalzheimers

9.) FLURIZAN & Alzheimer's Disease - http://www.myriad.com/alzheimers/flurizan.php

10.) FLURIZAN Alzheimer's Disease Phase 3 Clinical Trial (Global) - http://www.myriad.com/research/alzheimers-disease-clinical-trial-global.php

11.) Tarenflurbil Well Tolerated, May Slow Decline in Function in Mild But Not Moderate alzheimer's - http://www.medscape.com/viewarticle/573841

12.) Myriad Genetics Doesn't Make the Grade - http://www.thestreet.com/b/newsanalysis/biotech/10337586.html

13.) Myriad's 24-Month Study of Flurizan Demonstrates Significant Benefit in Alzheimer's Disease Patients - http://www.investors.com/breakingnews.asp?journalid=40531712

14.) MYRIAD GENETICS ENROLLS PATIENTS IN ALZHEIMER'S STUDY - http://www.fdanews.com/newsletter/article?issueId=9924&articleId=91214

15.) Disease - modifying drugs for Alzheimer's: Hope or hype? - http://www.health.harvard.edu/newsweek/Disease-modifying-drugs-for-Alzheimers.htm

16.) Myriad Genetics: Flurizan hot on the heels of Neurochem's Alzhemed - http://www.pharmaceutical-business-review.com/article_feature.asp?guid=E332D99B-3181-483B-B3E8-38F1A0E996E6

17.) Neurochem hammered on Alzhemed failure - http://www.fiercebiotech.com/story/neurochem-hammered-alzhemed-failure/2007-08-27