Many experts found the efficacy data from the Phase II trial mixed and the safety signals about brain swelling — vasogenic edema — concerning.In spite of these concerns, the companies decided to move forward with the Phase III clinical trial before the full results of the Phase II trial were completed.
According to Michael Lampe, a Wyeth spokesman, part of the clinical trial is now being discontinued.
“The decision to discontinue was made in concurrence with the Safety Monitoring Committee...Their review included assessment of the frequency and severity of VE in all the dose groups.”Lampe said he didn’t have the specifics about the number of VE cases that were observed.
The clinical trial will no longer be available to patients receiving the highest dose of the drug. Otherwise, the companies plan to continue the trial as planned.
The Phase III clinical trial for Bapineuzumab is still open and recruiting participants. To learn more about the clinical trial go here.