Shares in Advaxis surged as much as 38 percent Wednesday after the FDA lifted clinical holds on the investigational drugs axalimogene filolisbac, ADXS-PSA and ADXS-HER2. The agency placed a clinical hold on axalimogene filolisbac in October after Advaxis disclosed that a patient treated with the therapy in 2013 tested positive for listeria earlier this year and died within a month, with the hold also affecting clinical studies of ADXS-PSA and ADXS-HER.
Last month, US authorities concluded that the patient's death was due to cervical cancer progression. Meanwhile, following discussions with the FDA, Advaxis agreed to implement particular risk mitigation measures, including revision of the study protocol inclusion and exclusion criteria, post-administration antibiotic treatment and patient surveillance and monitoring measures.
"We appreciate the FDA's review of this matter," said Advaxis CEO Daniel O'Connor, adding "we are grateful that our clinical trials will now resume." The drugmaker noted that the nine clinical trials affected by the clinical holds will resume immediately.
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