BioCentury's websites will be down for upgrades starting at 9 p.m. PDT on Monday, August 26. We expect the downtime to last no more than 6 hours, and we apologize for any inconvenience.

12:00 AM
Aug 04, 2008
 |  BioCentury  |  Product Development

Elan's Phase III dash

Final Phase II data released last week from a Phase II trial of bapineuzumab in Alzheimer’s disease raised red flags, especially after Elan Corp. plc and partner Wyeth had put a positive spin on preliminary data released in June. But Elan said there is no point in doing more Phase II work on the mAb, as the questions raised require the size of the Phase III trials the companies started last December.

Bapineuzumab targets beta amyloid, the primary component of amyloid plaques that is considered to be the causative agent in the pathology of the disease.

When preliminary top-line results were released in June, the companies announced that the overall safety and efficacy findings supported their design and initiation of Phase III trials.

Although they reported that results on the pre-specified efficacy endpoints were not significant, there was significance in the subgroup population who did not carry the apolipoprotein E4 allele (APOE4) (see BioCentury, June 23).

Last week, complete data presented at the International Conference on Alzheimer’s Disease meeting in Chicago showed a lack of dose response for the study’s two main efficacy endpoints: change from baseline in Alzheimer’s Disease Assessment Scale (ADAS-cog) and Disability Assessment Scale for Dementia (DAD). In addition, 12 patients in the treatment arm had vasogenic edema on MRIs.

The trial had safety and tolerability as its primary outcome measure; according to the company, the study was not powered to demonstrate statistical significance on the secondary efficacy outcomes.

A total of 234 patients with mild-to-moderate AD were...

Read the full 1249 word article

User Sign in

Trial Subscription

Get a 4-week free trial subscription to BioCentury

Article Purchase

$150 USD
More Info >