Advaxis Updates Phase I Trial Survival Data: 23% of Patients Still Surviving after 2+ Years
NORTH BRUNSWICK, N.J.--(BUSINESS WIRE)--Mar 23, 2009 - Advaxis, Incorporated (OTCBB: ADXS), has updated survival data for its Phase I trial of its live Listeria vaccine ADXS11-001(formerly named Lovaxin-C) in patients with recurrent, metastatic, carcinoma of the cervix. While the Phase I safety trial was not designed to evaluate efficacy or survival as its primary endpoints, Advaxis has continued to follow the survival of the study participants.
As of March 17, 2009 three (3) of the thirteen (13), or twenty-three percent (23%), evaluable patients in the Phase I clinical trial continue to survive beyond the historical median survival of six (6) months (180 days) or less, based on the National Cancer Institute's Gynecologic Oncology Group (GOG) statistics for the treatment of recurrent, metastatic cervical cancer.
These three (3) patients have survived, respectively, 763 days, 864 days and 894 days after having received their first dose of ADXS11-001.
As inclusion criteria for the ADXS11-001 Phase I study, all patients had failed first line chemotherapy, and most patients had received both chemotherapy and radiation. GOG determined median survival rates in studies of other treatments in patients who have failed prior chemotherapy, vary between 3.8 and 6.2 months (GOG Protocol #127). Median survival for the thirteen (13) ADXS11-001 patients is approximately twelve (12) months (347 days).
Advaxis has applied to the FDA for Orphan Drug Designation for ADXS11-001 in the United States, where approximately 11,000 new cervical cancer cases are diagnosed annually. The FDA has already accepted an Advaxis IND for a Phase II study of ADXS11-001 in cervical intraepithelial neoplasia (CIN), the pre-cancerous phase of human papilloma virus (HPV)-caused cervical cancer.
About Advaxis, Incorporated
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.
About the ADXS11-001 Immunotherapy
Advaxis' technology platform uses modified Listeria monocytogenes to deliver a tumor-specific antigen fusion protein. Pre-clinically, bioengineered attenuated Listeria that secrete Advaxis' proprietary fusion protein have the ability to generate a robust immune response, break immune tolerance to cancer and produce an unusually strong and effective multi-level therapeutic immune response to existing cancer and other diseases.
Advaxis' Listeria-based technology is based on over a decade worth of work by Dr. Yvonne Paterson in her laboratory at the University of Pennsylvania. The Company's proprietary antigen fusion protein technology stimulates innate immunity i.e., both arms of the adaptive cellular immune system, suppresses regulatory T-cells that inhibit many vaccines in the function of activated tumor-killing cells in addition to other anti-tumor effects.
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. Advaxis has already filed an IND for a Phase II trial in HPV-caused cervical intraepithelial neoplasia (CIN), which is pre-cancerous.
For further information on ADXS11-001, please visit: www.advaxis.com/lc.htm.
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: March 2009