=Advaxis (ADXS) : cancer-drug study on hold after death

Advaxis announces clinical hold in Axalimogene Filolisbac Phase 1/2 combination study with AstraZeneca's IMFINZI; reports Q1 results 

• The company received notification from the U.S. Food and Drug Administration (FDA) that its Investigational New Drug (IND) application for its Phase 1/2 combination study of axalimogene filolisbac with IMFINZI (durvalumab) for the treatment of patients with advanced, recurrent or refractory human papillomavirus (HPV)-associated cervical cancer and HPV-associated head and neck cancer was placed on clinical hold. The clinical hold pertains to a recent submission of a safety report to the FDA regarding a Grade 5 Serious Adverse Event (patient death) on February 27, 2018 involving respiratory failure which occurred following the sixth combination cycle in the trial. Enrollment and further dosing are on hold in this trial while the company, its partner and the FDA work closely with the site investigator to review this event in detail and to resolve this clinical hold. Enrollment and dosing in all other Advaxis clinical programs are unaffected at this time.
• The net loss for the first quarter ended January 31, 2018 was $20.5 million or $0.49 per share based on 41.4 million shares outstanding
• Advaxis plans to continue to invest in its core clinical programs and expects its current cash position will be sufficient to fund its business plan into the second calendar quarter of 2019.