Missing upon its main measure of effectiveness, Elan and Wyeth’s, Bapineuzumab - drug to combat Alzheimer’s disease - failed to put up the best score in its Phase II trails, the mid-stage trial data released at the International Conference on Alzheimer’s on Tuesday revealed.
While the drug Bapineuzumab helps in curbing the Alzheimer’s disease in some patients, it raises the risk of a potentially serious side-effect - fluid buildup in the brain - especially in people who have a specific gene mutation called ApoE4, results showed.
For the Phase II trail of the drug, drug makers enrolled 234 patients with mild to moderate Alzheimer's disease. Of the lot, 229 patients were put on four different doses of the drug or a placebo.
The patients were to receive six doses of the drug via intravenous infusion over about 18 months.
Thereupon, measuring the patients’ ability on tests like the Alzheimer's disease assessment scale-cognitive subscale, or ADAS-cog, and the disability assessment scale for dementia, or DAD, bapineuzumab did not significantly improve cognitive and functional ability versus placebo, the researchers noted.
Patients treated with bapineuzumab recorded a minimal improvement of 2 to 3 points over those treated with a placebo on the cognitive function test. Bapineuzumab users could not fare better on the Disability Assessment Scale either.
However, the drug fared better on efficacy in a particular group of patients – those without the ApoE4 gene - the gene that predisposes one to Alzheimer’s.
In ApoE4 non-carriers, bapineuzumab usage significantly improved cognitive and functional ability; conversely, in the group carrying the ApoE4 gene, patients were at a high risk of developing a potentially serious side effect - a fluid build-up in the brain called vasogenic edema.
Moreover, vasogenic edema was strongly linked with the dosage administered and "the higher doses get more," Ronald Black, Wyeth’s assistant VP in neuroscience research said.
Though the share prices took a u-turn at the closing, some still hold optimistic views about the drug.
Scott Turner, incoming director of the Memory Disorders Program at Georgetown University Medical Center in Washington quoted, "I think the (drug’s) side effects are going to be perhaps significant, but if they are temporary and tolerable and if the drug shows a benefit, the risk-benefit ratio will be worth the side effects."
"This is potentially the first disease-modifying therapy," Turner marked.
Simply euphoric with the results, Sid Gilman of the University of Michigan, who helped with the study said, "We have absolutely dynamite data…There is a very strong signal among non-carriers, suggesting a beneficial effect."
Earlier in June, the drug makers had announced that an experimental drug for Alzheimer’s disease showed positive results and helped improve brain functioning in patients with the degenerative brain disorder.
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