Advaxis said that this initiation follows extensive review by the office of the Drugs Controller General of India, a blue ribbon commission of scientists convened to assess Advaxis clinical protocol, and a chemical and microbiological assessment of ADXS11-001 by the Indian Central Vaccine Research Laboratory at Kasuli.
The US National Cancer Institute’s Gynecologic Oncology Group has conducted 16 clinical trials in over 500 patients using various therapeutic regimens in this patient population and found effective regimen tested resulted in a median survival of approximately 6 months and a 1 year survival of 5%.
By contrast, in a Phase 1 study not designed to show efficacy, ADXS11-001 demonstrated a median survival of 347 days and a one year survival of 53%.
Advaxis intends to report the effect of ADXS11-001 on survival versus these historical values in real time, as the trial progresses, beginning in Summer, 2011.
Advaxis Indian Phase II Trial of ADXS11-001 differs from Advaxis Phase I trial in this patient population in two significant ways.
First, the Phase II will assess the more therapeutic regimen of three doses compared with two in Phase I, second, this randomised trial compares ADXS11-001 alone with ADXS11-001 combined with platinum based chemotherapy.
Patients will be randomly assigned to receive either three administrations of ADXS11-001 (55 patients) or a single dose of the immunotherapy, followed by cisplatin treatment, followed by a three course regimen of ADXS11-001 (55 patients).