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Elan drops top Alzheimer's drug dosage in trial
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Researchers for Elan and Wyeth have decided to drop the highest dose of their Alzheimer's drug bapineuzumab from two late-stage studies after determining that patients in the study were at risk of swelling of the brain. Patients taking the higher dose are being switched to a lower dose of the drug.
These particular trials recruited patients who don't have the ApoE4 gene, which increases risk of brain swelling. TheStreet's Adam Feuerstein notes that the move to drop the dose indicates the risk of brain swelling is higher than either company anticipated. Two other late stage trials that are testing a lower dose of the drug are not affected.
"Our review of the safety data and the feedback from the Safety Monitoring Committee made it clear that continued development of the highest dose was not advisable," said Elan President Carlos Playa in a statement. "The decision to remove the highest dose from development reduces risk to patients and it also helps to reduce risk to the overall development effort."
Researchers have been dogged by disagreement over the implications of a mid-stage study. Researchers concluded that the therapy improved cognition in patients without the critical gene, but some said the results were unconvincing.
The companies didn't disclose how many patients could have been affected.
- here's Elan's statement
- read the report from TheStreet
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Comments
By Anonymous | Posted 3:25pm | April 2, 2009
This event is a big plus. Phase 2 trials showed that rapid removal of amyloid from brain capillaries allowed blood fluid to leak through minute punctures in capillaries caused by amyloid build up. This finding is affirmed by today's news. Lower dossage removes the amyloid imbedded in the capillary walls at a slower rate allowing the capillaries to repair the punctures thereby preventing this brain fluid leakage and preventing fluid build up in the brain. Simple logic. The FDA apparently encouraged this trial of the highest dossage. The results dictated a lower dossage with those patients involved. The lower dossage has been tolorated well showing no further fluid leakage as the capillaries have healed the earlier punctures.
