The FDA placed a partial clinical hold on the ongoing randomized, double-blind, placebo-controlled AIM2CERV trial, which is evaluating axalimogene filolisbac in high-risk, locally advanced cervical cancer.
The partial hold is related to the FDA’s requests for additional information pertaining to chemistry, manufacturing and controls matters of axalimogene filolisbac (Advaxis), also called AXAL.
The FDA did not cite any safety issues, and all patients currently enrolled in the trial will continue to receive treatment per the trial protocol. However, no new patients will enroll until the partial hold is lifted.
“FDA’s review of the AXAL investigational new drug 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,” Kenneth A. Berlin, president and CEO of Advaxis, said in a press release. “The primary focus of the items raised by the [FDA] relates to providing additional clarifying details for [chemistry, manufacturing and controls] information previously provided in support of phase 3 development.
“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,” he added.