Avax M-Vax and O-Vax
Executive Summary
Clinical activities for its M-Vax and O-Vax autologous cancer vaccines have been placed on clinical hold pending further FDA review, company announces. "The FDA is currently examining the need to establish the sterility of tumor cells received by the company to prepare individualized cancer vaccines," Avax said. Firm maintains hold is not related to any concern with manufacturing, but is part of FDA's "evolving requirements for cell-derived products"