Advaxis' Clinical Trial Survival Data Significantly Exceeds the National Cancer Institute's Median Survival Statistic
23% of “Stage-Four” Metastatic Cervix Cancer Patients Treated With Live Listeria Vaccine ADXS11-001 Alive After 3 Years
NORTH BRUNSWICK, N.J.--(BUSINESS WIRE)--Jun 15, 2009 - Advaxis, Incorporated (OTCBB: ADXS), has updated survival data for its Phase I clinical trial (Trial) of its live Listeria vaccine ADXS11-001(formerly named Lovaxin-C) in the treatment of advanced, metastatic cervix patients who have failed first line cytotoxic therapy.
As of June 12, 2009 three (3) of the thirteen (13) evaluable patients in the Trial, approximately twenty-three percent (23%), are still alive at 981 days, 949 days and 850 days, respectively. The Trial's median patient survival was 347 days. Of the 15 patients treated in the trial, eight patients (53%) survived at least one year.
These figures significantly exceed the median survival rate established by the National Cancer Institute's Gynecologic Oncology Group (GOG). The GOG's median survival rate varies between 3.8 and 6.2 months in studies of patients who have failed prior chemotherapy (GOG Protocol #127).
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) has approved Advaxis' application 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: www.advaxis.com/lc.htm.
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.
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: June 2009