The commencement of the trial had been expected at the end of 2005, but is now expected to move into 2006.
An accelerated stability study of a vaccine lot manufactured to test phase III manufacturing processes and equipment indicated a stability problem, which may have been due to excess moisture in the product.
Accelerated stability studies are intended to provide data to predict long-term product stability under normal storage conditions. The companies, working with the contract manufacturer, are focused on resolving this issue as quickly as possible.
“We are working with Merck KGaA and others to discover the cause of the problem now evident during the manufacturing process and to take corrective action as quickly as possible,” said Dr Alex McPherson, president and CEO of Biomira.