ARTICLE | Clinical News

FDA places hold on Advaxis' combo trial

March 12, 2018 11:33 PM UTC

Advaxis Inc. (NASDAQ:ADXS) fell $0.49 (22%) to $1.72 in after-hours trading Monday after it said FDA placed a clinical hold on a Phase I/II trial of axalimogene filolisbac (ADXS11-001) in combination with PD-L1 inhibitor Imfinzi durvalumab to treat HPV-related cancers.

According to the company, the hold is related to a patient death reported on Feb. 27 involving respiratory failure following the sixth cycle of combination treatment in the trial. Advaxis said it will work with the site investigator and FDA to review the death and determine a path forward...

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