Neurochem announces the launch of North American Phase III clinical trial on Alzhemed™ for the treatment of Alzheimer's Disease.
- Neurochem Inc. (NASDAQ: NRMX; TSX: NRM) announced today 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 U.S. and 20 Canadian clinical centers across North America.
The multi-center, 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.
"We are on schedule for the launch of our Phase III clinical trial program on Alzhemed™," said Dr. Francesco Bellini, Chairman and CEO of Neurochem. "We are encouraged by the interest shown by the medical community in this Phase III trial and by the attendance at the investigators meeting by clinicians from all 70 sites to ensure that the trial protocol is well harmonized throughout all of North America. 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.
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 U.S. clinical sites and Professor of Neurology and Medicine, and Director, Memory Disorders Program, at Georgetown University Medical Center in Washington, D.C. "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."
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.
"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."
I'm still looking around to find some more, updated information.
I'd like to really get this community active. I really want to encourage everyone to share stories, pictures, art, anything. (Keeping to the topic of Alzheimer's, or loved ones suffering with Alzheimer's, please.)
The difficulty with support groups is the overwhelming pessimism (and unfortunately, more often than not--justified
pessimism). Right now, there is no cure for Alzheimer's. There are some drugs that can cause temporary relief, but for people suffering from late stages of Alzheimer's, there is really nothing that can be done. But Alzheimer's doesn't just effect the person suffering--it effects their entire family.
For people currently suffering with Alzheimer's, we have to remember those clear days, where your loved one is lucid and almost seems normal, or well. Cling to those days, and make them something wonderful.
For people who have dealt with Alzheimer's, who's loved ones have passed on, remember the days before Alzheimer's, before the dazed looks and struggle to remember insignificant things.
Again, I'd like to really encourage everyone to share stories, pictures, art, whatever.