Advaxis reports 3-year survival data from its ADXS11-001 Phase I trial for cervical cancer

Dec 29 2009

The Phase I trial of ADXS11-001, the lead vaccine candidate of Advaxis, Inc., (OTCBB: ADXS), the company that pioneered the live, attenuated Listeria monocytogenes (Lm) vaccine, has shown thirty-six (36) month survival in two (2) of the thirteen (13) evaluable patients treated with Advaxis’ therapeutic cancer vaccine, indicating the possibility of persistent immune protection, from only a two (2) dose initial regimen.

The patients had participated in the first human trial of a live Listeria vaccine for the treatment of advanced, recurrent, metastatic cervix cancer in women who have failed prior cytotoxic treatment. Advaxis is tracking the survival of these patients at three (3) month intervals.

These mortality figures substantially exceed the median survival rate established by the National Cancer Institute's Gynecologic Oncology Group (GOG), which varies between 3.8 and 6.2 months in studies of patients who have failed prior cytotoxic treatment including chemotherapy with various agents (GOG Protocol #127).

Earlier this year, Advaxis published in the medical journal Vaccine the fact that four (4) of thirteen (13) evaluable patients, treated with ADXS11-001, experienced tumor reductions, two (2) patients had lesions disappear and fifty-three percent (53%) survived more than one (1) year; thus, posting a median survival rate of 347 days. Although this trial was designed to assess safety – not efficacy or survival – two (2) of the thirteen (13) patients or fifteen percent (15%) evaluable for efficacy are still alive, at over 1,000 days post-dosing with the study drug, as of December 10, 2009. One patient, who had been the longest surviving patient, passed away since the previous 90-day update.