The FDA has removed the partial clinical hold on a Phase 3 clinical trial, AIM2CERV, evaluating Advaxis' (NASDAQ:ADXS) axalimogene filolisbac (AXAL) in patients with high-risk locally advanced cervical cancer after receiving and reviewing the company's response to its request for additional chemistry, manufacturing and controls (CMC) information.
The agency suspended new enrollment in late January pending the company's response.
Advaxis plans to restart patient recruitment as soon as possible.
Axalimogene filolisbac is an immunotherapy based on the company's Lm Technology, which uses live attenuated bioengineered Listeria bacteria to deliver a fusion protein inside cancer cells which then stimulates the immune system to attack the cancer.
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