Advaxis Provides Updated Phase I Survival Data For Cancer Vaccine

Advaxis’s Vaccine candidate ADXS11-001, in phase I trial has shown 36 month survival in 3 of the 13 evaluable patients treated with the cancer vaccine (ADXS11-001), indicating the possibility of persistent immune protection.

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 3 month intervals.

Reportedly, 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 4 of 13 evaluable patients, treated with ADXS11-001, experienced tumor reductions, 2 patients had their lesions disappear and 53% survived more than 1 year; thus, posting a median survival rate of 347 days. Although this trial was designed to assess safety, not efficacy or survival, 3 of the 13 patients or 23% evaluable for efficacy are still alive at over 1,000 days, post-dosing with the study drug, as of September 29, 2009.

ADXS11-001 is a therapeutic vaccine that treats women who have already developed cervical cancer as a result of human papilloma virus (HPV) infection.

Earlier this year, the FDA granted Advaxis an IND for a phase II clinical trial in human papilloma virus- (HPV) caused cervical intraepithelial neoplasia (CIN), which is pre-cancerous and a precursor to cervix cancer.