On January 23, 2019 Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported receipt of notification from the U.S. Food and Drug Administration (FDA) that the Company’s ongoing Phase 3, randomized, double-blinded, placebo-controlled, pivotal study of axalimogene filolisbac (AXAL) in high-risk, locally advanced cervical cancer (AIM2CERV) has been placed on partial clinical hold (Press release, Advaxis, JAN 23, 2019, View Source [SID1234532835]). 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.

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"FDA’s review of the AXAL Investigational New Drug (IND) application was prompted by our 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," said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. "The primary focus of the items raised by the Agency relates to providing additional clarifying details for CMC information previously provided in support of Phase 3 development and which will help support a future Biologics License Application. We have already begun efforts to address the Agency’s requests for information and are working to respond as promptly as we can." He concluded, "Our AXAL product has demonstrated a manageable safety profile in the over 400 patients we have dosed to date and we look forward to enrolling new patients in our AIM2CERV trial after FDA agrees that the information we submit is responsive to its requests."