Fifteen Percent of ADXS11-001 Treated Cervix Cancer Patients Still Alive Three Years after Initial Dosing
Updated Advaxis Phase I Survival Data Indicates Continued Long-Term Immune Protection
NORTH BRUNSWICK, N.J.--(BUSINESS WIRE)--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.
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.
Based in North Brunswick, New Jersey, Advaxis is developing proprietary Listeria monocytogenes (Lm) cancer vaccines based on technology developed by Dr. Yvonne Paterson, professor of microbiology at the University of Pennsylvania and chairperson of Advaxis’ scientific advisory board. Advaxis is developing attenuated live Lm vaccines that deliver engineered tumor antigens, which stimulate multiple simultaneous immunological mechanisms to fight cancer.
In a recent Advaxis Phase I clinical trial, a live Lm vaccine directed against the tumor-associated antigen HPV-16-E7 was safely administered to fifteen (15) women with advanced metastatic cancer of the cervix. Although this first trial of an Lm vaccine in humans was not designed or powered to prove efficacy, Advaxis believes an efficacy signal was observed that will be further explored in two (2) planned Phase II trials in the US and India in cervical cancer and its predecessor condition, cervical intraepithelial neoplasia (CIN). Advaxis now has nine (9) distinct cancer fighting constructs in various stages of development, both directly and with academic collaborators. For further information on the Company, please visit: www.advaxis.com.
Certain statements contained in this press release are forward-looking statements that involve risks and uncertainties. The statements contained herein that are not purely historical are forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements deal with the Company’s current plans, intentions, beliefs and expectations and statements of future economic performance. Forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results in future periods to differ materially from what is currently anticipated. Factors that could cause or contribute to such differences include those discussed from time to time in reports filed by the Company with the Securities and Exchange Commission. The Company cannot guarantee its future results, levels of activity, performance or achievements.
Posted: December 2009