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Additional Positive Results Announced in Ongoing Phase II Extension Study for Alzhemed
Out of the 30 AD patients who had previously completed 12 months of treatment on Alzhemed, Neurochem is reporting on the 23 mild-to-moderate AD patients who have received the product candidate for 16 months. The mild-to-moderate AD patients (n=18)4 showed an average ADAS-cog score of +2.33 points, as opposed to +9.65 points on average in comparable historical controls5 with AD patients. The mild AD patients (n= 11) responded the best and showed a change from baseline in their average ADAS-cog score of -0.09 points. This result compares favorably with a score of +7.62 points on average in comparable historical controls. Five patients discontinued the treatment but not for reasons of drug related adverse events. The Company will report on the seven other patients later once they complete 16-months of treatment with Alzhemed.
Overall 82% of the mild AD patients had stabilized or improved cognitive function tests even after 16 months of treatment with Alzhemed.
"Neurochem's product candidate, Alzhemed has the potential to modify the progression of AD by acting directly on its core pathology, something which is of critical importance in the treatment of this disease, and something we have not seen before," said Dr. Serge Gauthier, Professor of Neurology and Neurosurgery, Psychiatry, Medicine and Associate Member of Pharmacology and Therapeutics at McGill University, former President of the Consortium of Canadian Centres for Clinical Cognitive Research (C5R) and co-President of the Symposium with Drs Ezio Giacobini and Jean-Pierre Michel from Geneva. "Alzhemed represents what we believe will become the new paradigm for AD treatment. Unlike current therapies, which treat just the symptoms of the disease, Alzhemed seems to address the underlying cause. If cleared by regulatory agencies, Alzhemed could provide an important treatment to benefit millions of Alzheimer patients," Dr. Gauthier concluded.
The complete data on all the patients who participated in the Phase II clinical trial and the OLPES for a period of up to 20 months will be presented by Dr. Paul S. Aisen at the 9th International Conference on Alzheimer's Disease and Related Disorders to be held in Philadelphia, Pennsylvania, USA, from July 17 to July 22, 2004. Dr. Aisen is the principal investigator of the Phase III clinical trial for Alzhemed in the United States, and is Professor of Neurology and Medicine at Georgetown University Medical Center.
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 Aß protein to reduce the amyloid-induced toxicity on neuronal and brain inflammatory cells associated with amyloid build-up in AD.
About the Phase III Clinical Trials for Alzhemed
Phase III clinical trials to evaluate the safety and efficacy of Alzhemed in AD are expected to begin in the first half of 2004. In preparation for the initiation of the trials, the manufacturing of the product candidate has been successfully completed and the selection of the clinical research organization has been finalized.
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 the day-to-day life.
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. It presents a major health problem for the United States because of its enormous impact on individuals, families, the health care system, and society as a whole. 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 AD is becoming the most widespread and costly age-related disorder in the United States; the total cost of the disease has been estimated at $100 billion per year.
1 - Mini Mental State Exam (MMSE): 19-25
2 - Mini Mental State Exam (MMSE): 13-18
3 - Alzheimer's Disease Assessment Scale, cognitive subpart (ADAS-cog). The ADAS-cog is a 70- point scale designed to measure, with the use of questionnaires, the progression and the severity of cognitive decline as seen in AD. The ADAS-cog scale quantifies the number of wrong answers. Consequently, a high score on the scale indicates a more severe case of cognitive decline. When analysing results, a negative score indicates the improvement of cognitive function and a positive score the deterioration of such function. The ADAS-cog has been validated by the regulatory authorities as the gold standard scale for the monitoring of cognitive function in AD patients. This scale is a compulsory parameter of efficacy when submitting for market approval of an AD drug to the authorities such as the Food and Drug Administration.
4 - n: number of patients per group.
5 - Stern, R.G., et al. Am.J.Psychiatry 151:3, March 1994.