Advaxis Phase I Survival Update
2 of 13 (15%) of Evaluable Patients Remain Alive 3.9 and 3.5 Years After Dosing, Respectively
NORTH BRUNSWICK, N.J.--(BUSINESS WIRE)--Jul 28, 2010 - Advaxis, Inc., (OTCBB: ADXS), the live, attenuated Listeria monocytogenes (Lm) immunotherapy company, has updated the survival information from its phase 1 trial of ADXS11-001 which assessed the safety of this agent in advanced, metastatic, progressive cervix cancer in women whose disease progressed subsequent to treatment with cytotoxic therapy.
The principal investigator for this study has reported that the two (2) patients who were alive in March of 2010 are still alive at 3.9 and 3.5 years post dosing. This observation supports the idea that live attenuated Listeria immunotherapies can result in long lived responses, possibly by stimulating persistent immune memory.
About Advaxis Phase I Trial of ADXS11-001
ADXS11-001 is a live, attenuated Listeria vaccine that targets the human papilloma virus (HPV) oncoprotein E7. HPV is recognized as the cause of cervix cancer. The oncoprotein E7 is one of the HPV proteins believed to be responsible. Doses of 1x109, 3.3x109 or 1x1010 cfu were administered to groups of five (5) women who had failed prior therapy including radiation and chemotherapy. In such cases, no therapy has been found to be effective and the median survival, once disease progression resumes, is typically six (6) months or less; depending upon the treatment given. The one-year historical survival for these patients is approximately five percent (5%).
The phase I trial of ADXS11-001 was intended to assess safety; and, like all phase I trials, was not powered for efficacy. No conclusions can be made based upon the small number of patients treated. However, in this trial, the median survival was 347 days and the one-year survival was fifty-three percent (53%).
About Advaxis, Inc.
Advaxis is a biotechnology company developing proprietary, live, attenuated Listeria monocytogenes (Listeria) vaccines that deliver engineered tumor antigens, which stimulate multiple, simultaneous immunological mechanisms to fight cancer. Today, the Company has nine (9) distinct, cancer-fighting constructs in various stages of development, directly and through strategic collaborations with such recognized sites of excellence as the City of Hope, the Roswell Park Cancer Institute, the National Cancer Institute, the University of Pittsburgh and Cancer Research – UK. Advaxis' technology was developed by Dr. Yvonne Paterson, professor of microbiology at the University of Pennsylvania and chairperson of Advaxis' scientific advisory board.
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.
Contact: Conrad F. Mir
Posted: July 2010