(Posted By: Josi Creek)
Although
this isn't directly related to Multiple Sclerosis, I feel this article
is important due to the trouble that has been surrounding Tysabri.
Recently they were cited for a misleading video about their product
(Tysabri), which grossly underestimated the risks associated with the
drug, and most
recently had to update the safety label of Tysabri after studies showed
a heightened risk of death among patients taking it. Some alzheimer's
medications have been used in the past for cognitive problems associated
with MS.
Elan
Corp. and Transition Pharmaceuticals have called a premature halt on
trials on the two highest doses of their experimental Alzheimer's drug
ELND005 after the deaths of nine study participants.
"Greater rates of serious adverse events, including nine deaths, were
observed among patients receiving the two highest doses. A direct
relationship between ELND005 and these deaths has not been established,"
the companies said.
The announcement was greeted as particularly bad news for Elan, which
recently had to update the safety label of its multiple sclerosis drug
Tysabri after studies showed a heightened risk of death among patients
taking it.
Elan and Transition had already completed a successful Phase I trial of
the new drug, which showed that it built up in high concentrations in
the brain and appeared to preserve higher levels of a key
nerve-protecting enzyme. In the Phase II trial, the companies had been
testing 353 people with either 250 milligram, 1,000 milligram or 2,000
milligram doses of the drug.
The decision to halt the two higher-dose trials was made in consultation
with the study's Independent Safety Monitoring Committee. As no deaths
were seen in the 250 milligram group, those tests will continue.
Although there was little effect on the companies' stock prices,
analysts predicted an uphill battle for approval of the experimental
drug.
"This is a considerable blow for the progress of the drug," Ian Hunter of Goodbody said.
"At the very least, efficacy at the lower dose will need to be
compelling to justify development and ultimate approval," said Jack
Gorman of Davy Stockbrokers.
Elan is also developing another Alzheimer's drug, this one in
partnership with Johnson & Johnson, but progress on that product is
not nearly as advanced.
Alzheimer's disease is the most common form of dementia, affecting more
than five million people in the United States alone. The disease is
characterized by a progressive loss of cognitive function, and is
currently incurable. An Alzheimer's drug has been called the "holy
grail" for pharmaceutical companies, but so far no effective cures seem
forthcoming.
