The US Food and Drug Administration has put on hold the mid-stage clinical trials involving a experimental cancer drug from Advaxis (ADXS) after a patient died.
The clinical hold on the drug, axalimogene filolisbac, was issued after Advaxis submitted a safety report to the FDA.
The safety report focused on a female patient with end-stage cervical cancer who last received axalimogene filolisbac in early 2013 in an investigator-initiated trial. The patient was hospitalized for end-stage cervical cancer symptoms in July of this year.
Advaxis believes the patient died due to the progression of cervical cancer, but FDA is asking for additional information to confirm the company's experimental therapy, axalimogene filolisbac, played no role. Until the FDA's concerns are resolved, four clinical trials involving Advaxis' axalimogene filolisbac are on clinical hold.
But in mid-August, Advaxis said, the patient returned to the hospital with respiratory distress caused by her metastatic disease. She died later that day. The trial investigator found that the cause of death was progression of her cervical cancer.
Advaxis said the FDA has asked for additional information to prove that the drug did not contribute to the patient's death.
Axalimogene filolisbac is being tested in patients with Human Papilloma Virus-associated cancers.