- Advaxis (ADXS) reports that the FDA has placed its Phase 1/2 clinical trial assessing the combination of axalimogene filolisbac and AstraZeneca's (AZN) IMFINZI (durvalumab) in patients with advanced, recurrent/refractory human papillomavirus (HPV)-associated cervical cancer and HPV-associated head and neck cancer on clinical hold.
- The agency took action after receiving a report of a patient death due to respiratory failure after the sixth treatment cycle. The company says it, along with its partner, will work closely with the FDA to investigate the event and resolve the clinical hold.
- The company says its other clinical programs will continue as is.
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Update: Shares are down 22% premarket on Tuesday, March 13, on average volume.