FDA Removes Clinical Hold on Advaxis IND Applications

The good news keeps coming for Advaxis. Days after the Princeton, N.J.-based company scored orphan status in the EU for its anal cancer candidate axalimogene filolisbac, the FDA lifted a clinical hold on all of its IND applications.

As a result of the agency’s decision, Advaxis may resume clinical studies with axalimogene filolisbac, ADXS-PSA and ADXS-HER2.

The announcement came a little more than two months after the FDA placed a clinical hold on axalimogene filolisbac following the death of a patient in a trial. That move covered four trials evaluating the candidate in three areas: anal, cervical and head and neck cancers.

To restart its trials, the company agreed to implement certain risk mitigation measures, including revised study protocol inclusion and exclusion criteria.