O – Advaxis Inc said the U.S. Food and Drug Administration has put on hold the mid-stage trials of its experimental cancer drug after a patient died, sending its shares down 27 percent in extended trading.
The clinical hold on the drug, axalimogene filolisbac, was issued after Advaxis submitted a safety report to the FDA, the company said on Tuesday.
The company, however, said the patient died due to progression of cervical cancer and the drug played no role in her death.
The patient was admitted with advanced form of cancer and received axalimogene filolisbac in early 2013 in an "investigator-initiated" trial.
The patient was discharged but she returned to the hospital in mid-August with respiratory distress caused by the disease.
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.
Advaxis' shares closed at $10.31 on the Nasdaq on Tuesday. (Reporting by Rosmi Shaji in Bengaluru; Editing by Don Sebastian)