FDA lifts clinical hold on Advaxis' cancer compounds
Drug developer Advaxis Inc said on the U.S. Food and Drug Administration had lifted a clinical hold on three of its experimental cancer therapies, sending the company's shares up as much as 38 percent.The U.S. health regulator had in October put on hold mid-stage trials of the company's lead therapy, axalimogene filolisbac, after a patient died.Advaxis had then said the patient died due...
The U.S. health regulator had in October put on hold mid-stage trials of the company's lead therapy, axalimogene filolisbac, after a patient died.
Advaxis had then said the patient died due to progression of cervical cancer and that the drug played no role in the death.
The FDA later placed a clinical hold on all three therapies in the company's pipeline.
Advaxis said that it would resume studies on the three therapies, which belong to a class of treatments that spur the body's immunity system against the disease.
The company said it had agreed to implement some risk mitigation measures, including revised study design, patient inclusion criteria and patient surveillance measures, following discussions with the FDA.
Advaxis is testing axalimogene filolisbac in patients with head and neck cancer, cervical cancer and anal cancer.
The company is studying ADXS-PSA in prostate cancer patients in combination with Merck & Co's blockbuster cancer drug Keytruda, and ADXS-HER2 in patients whose cancer is caused by a kind of mutation.