Apthera receives special protocol assessment (SPA) from FDA for pivotal phase III trial of NeuVax in early-stage breast cancer

June 25, 2009

By Flinn Foundation

[Source: ] – Apthera, Inc. today announced that it reached an agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for its planned Phase III clinical trial of the Company’s lead drug, NeuVax. The SPA is a written agreement between the trial’s sponsor and the FDA regarding the design, endpoints, and planned statistical analysis of the Phase III trial to be used in support of a Biologics License Application (BLA).

The SPA approval letter was received from the FDA on June 19, 2009, concluding a 21-month reiterative process between Apthera, the breast oncology community in the U.S. and the Agency.

For more information: Apthera Receives Special Protocol Assessment (SPA) From FDA for Pivotal Phase III Trial of NeuVax in Early-Stage Breast Cancer