Phase III AIM2CERV trial of Axal in cervical cancer placed on hold by FDA.- Advaxis

Advaxis announced receipt of notification from the FDA that the Company�s ongoing Phase III, randomized, double-blinded, placebo-controlled, pivotal study of Axal (axalimogene filolisbac) in high-risk, locally advanced cervical cancer (AIM2CERV) has been placed on partial clinical hold. The FDA�s recent communication, received late last week, states that the partial hold is related to their requests for additional information pertaining to certain AXAL chemistry, manufacturing and controls (CMC) matters.

The Agency did not cite any safety issues related to the trial and all currently enrolled patients will continue to receive treatment, per the trial protocol. However, no new patients can enroll in AIM2CERV until resolution of this partial hold. FDA�s review of the AXAL Investigational New Drug (IND) application was prompted by the company's proposal to modify the AIM2CERV trial�s analysis plan to include, among other things, allowance for a second formal interim analysis for both safety and efficacy.