LAVAL, QC, June 21 /PRNewswire-FirstCall/ - Neurochem Inc. announces that it has received a third recommendation from the European Data Safety Monitoring Board (DSMB) to continue its ongoing European Phase III clinical trial for tramiprosate (ALZHEMED(TM)), Neurochem’s investigational product candidate for the treatment of Alzheimer’s disease (AD).
The DSMB is made up of independent clinical experts who monitor and evaluate the safety of patients taking part in the tramiprosate (ALZHEMED(TM)) Phase III clinical trial. In Europe, this third recommendation by the DSMB members was based on their recent review of the available safety data from 747 patients who have been on study medication for an average of 5.7 months.
Neurochem is progressing with its multicenter, randomized, double-blind, placebo-controlled, three-armed and parallel-designed, 18-month Phase III clinical trial for tramiprosate (ALZHEMED(TM)) in Europe. This clinical trial was initiated in September 2005. More than 950 mild-to-moderate AD patients at close to 70 sites across ten European countries are already enrolled in this clinical trial. The recruitment will continue at least until after top-line results of the North American study are released. With respect to the completed Phase III North American clinical trial for tramiprosate (ALZHEMED(TM)), Neurochem received during the course of the clinical trial five recommendations from the North American DSMB to continue the study.
Tramiprosate (ALZHEMED(TM)) is a small, orally-administered molecule known as an amyloid (B) antagonist, which crosses the blood-brain-barrier, binds to soluble A(B) peptide and interferes with the amyloid cascade that is associated with amyloid deposition and the toxic effects of A(B) peptide in the brain.
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, all of which make it difficult for the person to participate in daily activities.
According to the U.S. Alzheimer Association (2007), there are now more than five million people in the United States living with Alzheimer’s disease. This number includes 4.9 million people aged 65 and older. It also includes at least 200,000 individuals younger than 65 with early-onset Alzheimer’s disease. It is estimated that by 2010, there will be 454,000 new cases of AD a year, 615,000 new cases by 2030 and 959,000 new cases by 2050. In the United States, the direct and indirect costs of AD and other dementias amount to more than US$148 billion annually.
About Neurochem
Neurochem Inc. is focused on the development and commercialization of innovative therapeutics to address critical unmet medical needs. Eprodisate (KIACTA(TM)) is currently being developed for the treatment of Amyloid A (AA) amyloidosis, and is under regulatory review for marketing approval by the U.S. Food and Drug Administration, the European Medicines Agency and Swissmedic. Tramiprosate (ALZHEMED(TM)), for the treatment of Alzheimer’s disease, has completed a Phase III clinical trial in North America and is currently in a Phase III clinical trial in Europe, while tramiprosate (CEREBRIL(TM)), for the prevention of Hemorrhagic Stroke caused by Cerebral Amyloid Angiopathy, has completed a Phase IIa clinical trial.
To Contact Neurochem
For additional information on Neurochem and its drug development programs, please call the North American toll-free number 1 (877) 680-4500 or visit our Web site at www.neurochem.com.
This news release contains forward-looking statements regarding tramiprosate (ALZHEMED(TM)), as well as regarding continuing and further development efforts. These statements are based on the current analysis and expectations of management. Drug development necessarily involves numerous risks and uncertainties, which could cause actual results to differ materially from this current analysis and these expectations. Analysis regarding the results of clinical trials may not provide definitive results regarding safety, tolerability or therapeutic benefits. There is no certainty that regulators will ultimately approve tramiprosate (ALZHEMED(TM)) for sale to the public. Risks and uncertainties may include: failure to demonstrate the safety, tolerability and efficacy of our product, that actual results may vary once the final and quality-controlled verification of data and analyses has been completed, the expense and uncertainty of obtaining regulatory approval, including from the FDA, and the possibility of having to conduct additional clinical trials. Further, even if regulatory approval is obtained, therapeutic products are generally subject to: stringent on-going governmental regulation, challenges in gaining market acceptance, and competition. Neither Neurochem Inc., nor Neurochem (International) Limited undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future events, or otherwise. Please see Neurochem Inc.'s Annual Information Form for further risk factors that might affect Neurochem Inc., Neurochem (International) Limited and their respective businesses.
For further information, please contact: Lise Hebert, Ph.D. Vice President, Corporate Communications Tel: (450) 680-4572 lhebert@neurochem.com
NEUROCHEM INC.
CONTACT: Lise Hebert, Ph.D., Vice President, Corporate Communications,(450) 680-4572, lhebert@neurochem.com
