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# FDA AIM2CERV Clinical Hold
- URL: https://www.fdaweb.com/fda-aim2cerv-clinical-hold/
- Published: 2019-01-24T12:00:00.000Z
- Updated: 2026-09-15T00:56:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143220

FDA has placed a partial clinical hold on Advaxis’ Phase 3 AIM2CERV trial of axalimogene filolisbac (AXAL) in high-risk, locally advanced cervical cancer. The company [says](https://ir.advaxis.com/press-release/advaxis-phase-3-aim2cerv-study-placed-partial-clinical-hold-fda-related-cmc?ref=fdaweb.com) the hold is related to FDA requests for additional information on certain AXAL chemistry, manufacturing, and controls matters. The agency did not cite any safety issues related to the trial, Advaxis says, and all currently enrolled patients will continue to receive treatment per the trial protocol. No new patients will be enrolled under the partial hold is resolved.

Company officials said they are working to respond to the FDA information request as quickly as possible.