Alzheimer's & Dementia Report on Alzhemed Clinical Trial Says Alzheimer's Stabilized in 4 of 9

Tramiprostate product reduces amyloid accumulation - major culprit in AD

April 24, 2006 – A presentation Saturday on the potential use of tramiprostate (Alzhemed) in the treatment of Alzheimer's disease said stabilization of the disease occurred in four out of nine patients with a mild form of AD after three years of treatment.

"Overall, the Alzhemed program is very exciting. The fact that this product can reduce amyloid accumulation, a major culprit in Alzheimer's disease, and provide a protective effect against amyloid-induced toxicity to brain cells is encouraging," said Paul S. Aisen, M.D., Professor of Neurology and Medicine at Georgetown University Medical Center, and principal investigator in the United States of the ongoing Phase III clinical trial for tramiprosate (Alzhemed).

"Developing a successful treatment to slow the progression of this disease, which today remains an unmet medical need, would be a major advance in the fields of neurology and age-related illnesses," he concluded.

The presentation on Neurochem's investigational product candidate for the treatment of AD by Dr. Aisen took place on April 22, in Geneva, Switzerland, at the 9th International Geneva/Springfield Symposium on Advances in Alzheimer Therapy.

The data from the open-label extension study of the Phase II clinical trial for tramiprosate, involving mild-to-moderate AD patients, continues to show clinically significant benefits on cognitive and global performance measures, with stabilization of the disease in a proportion of mild patients (four out of nine) after three years of treatment.

Furthermore, Dr. Aisen presented for the first time further results on the mechanism of action of tramiprosate (Alzhemed). In addition to the capability of tramiprosate (Alzhemed) to bind to soluble amyloid (B) (A(B)) peptide and interfere with the amyloid cascade, data from in vitro studies have shown that tramiprosate (Alzhemed) has a protective effect on neuronal cells against A(B) peptide-induced toxicity and cell death. Tramiprosate (Alzhemed) decreases A(B)42-induced cell death and DNA damage in neuronal cell cultures by 38% (p-value less than 0.01).

About the Phase III Clinical Trials for Alzhemed

Neurochem is currently conducting a randomized, double-blind, placebo- controlled and parallel designed 18-month Phase III clinical trial in 1,052 mild-to-moderate AD patients, which is being carried out at close to 70 clinical sites across the United States and Canada.

To date, more than 50 patients have completed the trial and more than 500 patients have completed 12 months on study medication. The trial is now scheduled to be completed by January 2007.

All patients who complete the North American Phase III clinical trial will be offered the opportunity to receive tramiprosate (Alzhemed) in an open-label extension study. As announced previously, this open-label extension study will be initiated in the second quarter of 2006.

Neurochem is also actively advancing an 18-month Phase III clinical trial for tramiprosate (Alzhemed) in Europe, which was initiated in September 2005. The ongoing European Phase III clinical trial, a multi-center, international, randomized, double-blind, placebo-controlled and parallel designed study, to investigate the safety and efficacy of tramiprosate (Alzhemed) in some 930 mild-to-moderate AD patients, is progressing on schedule.

Enrollment is brisk with more than 230 patients enrolled in the clinical trial and enrollment expected to be completed in the fall of 2006.

About tramiprosate (Alzhemed)

Tramiprosate (Alzhemed) is a small, orally-administered molecule known as an amyloid (B) antagonist that crosses the blood-brain-barrier, binds to soluble A(B) peptide and interferes with the amyloid cascade, inhibits A(B) protein deposition in the brain and provides protection against A(B)-induced neurotoxicity.

About Alzheimer's disease

Alzheimer's disease (AD) is a progressive form of dementia associated with specific brain pathologies. It impairs a person's cognitive and motor functions and gradually destroys the brain.

AD is the most common cause of dementia in our aging population. Almost 5 million individuals in the United States alone currently suffer from the condition. The U.S. Alzheimer's Association estimates that by 2025, over 22 million people worldwide will be afflicted.

According to a report commissioned by the U.S. Alzheimer's Association, AD costs American businesses approximately US$61 billion a year. That price tag includes US$24.6 billion for direct health care of Alzheimer's patients and US$36.5 billion to cover costs related to caregivers of AD patients, including lost productivity, absenteeism and worker replacement.

About Neurochem

Neurochem says it is focused on the development and commercialization of innovative therapeutics to address critical unmet medical needs. Eprodisate (Fibrillex) is designated as an orphan drug, is a Fast Track product candidate and is also part of FDA Continuous Marketing Application Pilot 1 and Pilot 2 programs. The FDA designated the eprodisate (Fibrillex) new drug application for priority review. Tramiprosate (Alzhemed), for the treatment of Alzheimer's disease, is currently in Phase III clinical trials in both North America and Europe, and tramiprosate (Cerebril), for the prevention of Hemorrhagic Stroke caused by Cerebral Amyloid Angiopathy, has completed a Phase IIa clinical trial. Neurochem, Inc. NASDAQ: NRMX) (NASDAQ:TSX:) (NASDAQ:NRM)

Suggested additions/updates?
e-mail :updates@tramiprostate.com


HOME
nootropic.com
Just For Chemists
The Good Drug Guide
The Drug Companies
Depression and Antidepressants
Alzheimer's disease : health resources