Back in October, the FDA slammed the brakes on four studies involving Advaxis' ($ADXS) cervical cancer vaccine, axalimogene filolisbac, dubbed ADXS-HPV. The Princeton, NJ-based company announced on Wednesday that the FDA has lifted the clinical hold, allowing it to carry on with its clinical trials and sending its shares up 38%.
Advaxis will resume testing the candidate in three indications: invasive cervical cancer, head and neck cancer and anal cancer. It is in Phase II trials for cervical cancer and in Phase I/II for the other indications.
The clinical hold was placed in response to a safety report that the company submitted to the FDA, which included the death of a patient with end-stage cervical cancer. The trial's investigator ruled cancer progression as the cause of death, a conclusion with which Advaxis concurred.
The company agreed to enact risk-mitigation measures after discussing them with the FDA, Reuters reported. These include revised study design, patient inclusion criteria and patient surveillance measures, Reuters said.
In September, Advaxis reported "some of the most encouraging data to date in metastatic cervical cancer," from the first stage of its Phase II trial of ADXS-HPV. The company reported that 38.5% of patients who had previously failed at least one line of therapy were still alive after 12 months when each patient had been estimated to live four to 7 months. According to the company's statement, the Gynecologic Oncology Group has conducted more than 17 studies of investigational agents and not one posted a 12-month survival rate above 30%.
- here's the Reuters story