Updated Advaxis Phase I Survival Data Indicates Long-Term Immune Protection

Main Category: Cervical Cancer / HPV Vaccine
Also Included In: Immune System / Vaccines;  Clinical Trials / Drug Trials
Article Date: 04 Oct 2009 - 0:00 PDT

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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 three (3) of the thirteen (13) evaluable patients treated with Advaxis' therapeutic cancer vaccine, 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 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 their 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, three (3) of the thirteen (13) patients or twenty-three percent (23%) evaluable for efficacy are still alive at over 1,000 days, post-dosing with the study drug, as of September 29, 2009.

About the ADXS11-001 Immunotherapy

ADXS11-001 is a therapeutic vaccine, unlike currently marketed prophylactic vaccines, that treats women who have already developed cervical cancer as a result of human papilloma virus (HPV) infection; the most prevalent sexually transmitted disease in the US today.

Earlier this year, the US Food and Drug Administration (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. For further information on ADXS11-001, please visit: http://www.advaxis.com/lc.htm.

Source
Advaxis

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