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
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.