Health and Healthcare

Advaxis Skyrockets on Resumed Clinical Trials

Chris Lange

Published: December 16, 2015 10:10 am

Last Updated: January 13, 2020 4:02 pm

Advaxis Inc. (NASDAQ: ADXS) was absolutely running away early in Wednesday’s regular session on the release of an U.S. Food and Drug Administration (FDA) restriction. The company announced that the FDA has lifted the clinical hold on all of the company’s Investigational New Drug (IND) applications for its three product candidates: axalimogene filolisbac, ADXS-PSA and ADXS-HER2.

As a result, the company will resume all clinical trials for the aforementioned candidates.

Advaxis received notification from the FDA in October that its IND applications for axalimogene filolisbac were put on clinical hold in response to the company’s submission of a safety report to the FDA. The clinical hold also included the INDs for ADXS-PSA and ADXS-HER2.

Following discussions with the FDA and in accordance with their recommendations, Advaxis agreed to implement certain risk-mitigation measures, including revised study protocol inclusion/exclusion criteria, post-administration antibiotic treatment and patient surveillance and monitoring measures.

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