Product stability is at issue.
VaxGen received a clinical hold notification from the FDA that will postpone the initiation of its second Phase II trial for rPA102, the company’s anthrax vaccine. The FDA’s CBER says that data submitted to date by the company is insufficient to determine that the product is stable enough to resume clinical testing.
In the notification, the agency expressed concerns that the vaccine’s potency could decline during the immunization phase of the trial, potentially resulting in an uninterpretable outcome. The notification is not related to any adverse event or preclinical finding related to the vaccine, the company stresses.
VaxGen, at the FDA’s encouragement, will meet with the agency as soon as possible to discuss approaches to satisfy the agency’s requirements so that the trial can be initiated. “We look forward to meeting with FDA/CBER to further understand their concerns and to examine possible ways to resume clinical development of rPA102,” mentions Lance K. Gordon, Ph.D., president and CEO of VaxGen.