Pfizer said in a statement that the test results from what’s called Study 302 have been shared with government regulators and doctors conducting the study so that patients participating in all the studies can be notified.
“While we are disappointed in the topline results of Study 302, a more complete understanding of bapineuzumab and its potential utility in mild-to-moderate Alzheimer’s disease will be gained following the availability of additional data,” Dr. Steven J. Romano, Pfizer’s head of primary care medicines development, said in a statement.
Bapineuzumab is an antibody-based drug that targets the beta-amyloid protein, the sticky plaque that clogs patients’ brains and is believed to play a central role in development of Alzheimer’s disease. Researchers are still analyzing the study’s data on biomarkers _ spinal fluid and brain imaging _ to see if bapineuzumab had any effect on clearing amyloid. If so, that might lend support to trying the drug earlier in the course of the disease, before people have so much plaque that it causes symptoms. The biomarker results will be presented at scientific conferences this fall, Sperling said.
Biomarkers are genes or measurable characteristics that indicate a normal biologic process, a disease or a response to a treatment.
“I would defer complete judgment on the drug until I see some biomarker data,” said Dr. Ronald Petersen, director of the Mayo Clinic’s Alzheimer’s Disease Research Center. “It still may leave the door open for some positive news if there are any biomarker movements.”
Many scientists believe the drugs are being tried too late, “like lowering the cholesterol after the heart attack,” said Petersen.
He had no role in these studies but consults for Pfizer on other potential Alzheimer’s treatments.
AP Chief Medical Writer Marilynn Marchione in Milwaukee contributed to this report.
Linda A. Johnson can be followed at http://twitter.com/LindaJ_onPharma
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