Advaxis (ADXS) Announces Clinical Hold in Axalimogene Filolisbac Phase 1/2 Combination Study with AstraZeneca's (AZN) IMFINZI

Advaxis (NASDAQ: ADXS) reported Q1 EPS of ($0.49), $0.06 better than the analyst estimate of ($0.55).

Clinical Hold

In the evening of March 9, 2018, 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.

“We care deeply for our patients and for their safety as we work to research and develop new treatment options for advanced cancers. We believe in the potential of our Lm Technology to provide new advancements in the area of cancer care,” stated Anthony Lombardo, interim Chief Executive Officer of Advaxis. “We are confident in the safety and efficacy profile of axalimogene filolisbac, to date, based on our experience in over 250 patients and over 700 doses across multiple trials in HPV-associated cancers.”

For earnings history and earnings-related data on Advaxis (ADXS) click here.

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