Advaxis, Inc., (OTCBB: ADXS), the live, attenuated Listeria monocytogenes (Listeria) immunotherapy company, has begun dosing patients in its 110 patient clinical trial of ADXS11-001 for the treatment of cervix cancer in women for whom cytotoxic treatment has failed.
This 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 initial patient is at the Dr. Kamakshi Memorial Hospital in Chennai.
The U.S. 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 the most 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 demonstrate a median survival of 347 days and a one year survival of 53%.
Because of the progressive and rapidly fatal nature of cervix cancer in women for whom cytotoxic treatment has failed, the design of this trial allows for a rapid appraisal of efficacy. 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.
Source: Advaxis, Inc.