Neurochem Inc announced that it has launched its North American phase III clinical trial on Alzhemed, following an investigators' meeting attended by more than 200 clinicians and clinical monitors held in Montreal from June 18 to June 20, 2004.
Alzhemed is the Company's investigational product candidate for the treatment of Alzheimer's Disease (AD). The trial will be conducted by 50 US and 20 Canadian clinical centres across North America.
"We are on schedule for the launch of our phase III clinical trial programme on Alzhemed," said Dr. Francesco Bellini, chairman and CEO of Neurochem. "The results of our phase II clinical trial and our on-going open-label phase II extension study appear to indicate that Alzhemed addresses not only the symptoms, but also has the potential to affect the progression of the disease, especially in mild AD patients," he added.
Results of the phase II trial demonstrated that there were no apparent safety findings of concern in patients treated with Alzhemed and that the investigational product candidate was well tolerated in individuals with mild-to-moderate AD. Furthermore, Alzhemed was detected in the cerebrospinal fluid of the patients, suggesting its ability to cross the blood-brain-barrier and its potential to act on amyloid, the underlying pathology of AD. The patients with the greatest decrease of amyloid protein, as measured by immunoassays, were on Alzhemed and the majority of mild AD patients on the highest dose showed stable or improved results on cognitive function tests even after 16 months of follow-up.
Alzhemed is an orally administered, small organic molecule that has been specifically designed to modify the course of AD by binding to amyloid ß (Aß) protein and keeping it in a non-fibrillar form. As part of a "disease modifying" class of product candidates, Alzhemed is expected to act at two levels- in preventing and stopping the formation and deposit of amyloid fibrils in the brain and in inhibiting the inflammatory response associated with amyloid build-up in AD.
"The most promising target in AD therapeutics is the amyloid peptide," said Dr. Paul Aisen, Alzhemed principal investigator for the US clinical sites and Professor of Neurology and Medicine, and director, Memory Disorders Programme, at Georgetown University Medical Center in Washington, DC. "This investigational product candidate has been shown in preclinical development to target the amyloid peptide. Neurochem's phase II study demonstrated that Alzhemed is well tolerated in individuals with AD.
Furthermore, the majority of patients receiving Alzhemed for a very long period in the open-label extension study, that is, for up to 16 months, have shown stable cognitive function tests, especially in the mild population," Dr Paul said.
"Neurochem's study on Alzhemed could offer new hope for the thousands of people afflicted with Alzheimer's disease," said Dr Serge Gauthier, Alzhemed principal investigator for the Canadian sites and Professor of Neurology and Neurosurgery, Psychiatry, Medicine and associate member of Pharmacology and Therapeutics at McGill University in Montreal, Canada. "The outcome measures during treatment with Alzhemed will accurately evaluate the daily life of participants and their families, as well as the biological changes associated with the disease," he added.
The multi-centre, randomized, double blind, placebo-controlled and parallel design North American phase III clinical trial will investigate the safety and efficacy of Alzhemed for the treatment of AD in approximately 950 mild-to-moderate patients. The patients will be randomized to receive either placebo or one of two different dose levels of Alzhemed for a period of 18 months. The Company anticipates launching its Alzhemed European phase III clinical trial early in 2005.
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 because of its enormous impact on individuals, families, the health care system, and society as a whole.