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Independent Safety Review Board Recommends Continuation of Phase 3 Trial for Alzhemed
"We are encouraged by the Independent Safety Review Board's recommendation and pleased that the study is continuing as planned," said Denis Garceau, PhD, Senior Vice President, Drug Development. "With over 1,000 patients screened, the recruitment in North America is proceeding on schedule and the study is on track for completion as planned."
Neurochem's ISRB for Alzhemed is made up of independent medical experts who monitor and evaluate the safety of patients taking part in the Alzhemed(TM) Phase III clinical trial in North America. The recommendation by the ISRB members was based on their recent review of the safety data from 562 patients who have been monitored in the trial for at least 12 weeks so far. After reviewing the safety information, the ISRB concluded that there were no significant safety concerns to report in the study and that the trial should continue as planned.
Alzhemed is an orally administered, small organic molecule that has been specifically designed to modify the course of AD through its anti-amyloid activity. As part of a "disease modifying" novel class of product candidates, Alzhemed is expected to act at two levels: in preventing and stopping the formation and the deposition of amyloid fibrils in the brain and in binding to soluble A(B) protein to reduce the amyloid-induced toxicity on neuronal and brain inflammatory cells associated with amyloid build-up in AD.
Alzhemed has entered into a multicenter, randomized, double-blind, placebo-controlled, three-armed, parallel-design Phase III clinical trial; 68 clinical centers have been enrolled in North America. The study will include some 950 patients who will receive study medication over a period of 18 months. The Company anticipates launching its Phase III trial in Europe in the fall 2005.
About Alzheimer's Disease
AD is a leading cause of death in older people. The disease is characterized by the progressive death of nerve cells in the brain, making it difficult for the brain's signals to be transmitted properly. A person with AD experiences problems with memory, judgment, thinking, and eventually with motor functions, which makes it hard for the person to participate in day-to-day activities.
According to the National Institute on Aging's "Progress Report on Alzheimer's Disease, 2000," AD is the most common cause of dementia among people aged 65 and older. Scientists estimate that up to four and a half million people in the United States currently suffer with the disease and the prevalence (the number of people with the disease at any one time) doubles every five years beyond age 65. It is also estimated that approximately 360,000 new cases (incidence) will occur each year and that this number will increase as the population ages.
In a 2000 report, the Biotechnology Industry Organization estimated that in the United States the total cost of AD has been estimated at US$100 billion per year.
Source: Neurochem Inc.