Advaxis' Phase 1 Clinical Cervix Cancer Study Accepted for Publication in Leading Peer-Reviewed Science Journal Vaccine
NORTH BRUNSWICK, N.J.--(BUSINESS WIRE)--Apr 29, 2009 - Advaxis, Inc. (OTCBB: ADXS) Phase 1 clinical study of the therapeutic cancer vaccine ADSX11-001 (formerly Lovaxin C) has been accepted for publication in the peer reviewed journal Vaccine and the abstract is available for review on PubMed (Maciag, Radulovic & Rothman; The First Clinical Use Of A Live-Attenuated Listeria Monocytogenes Vaccine: A Phase I Safety Study of Lm-LLO-E7 in Patients With Advanced Carcinoma of The Cervix.).
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The article discusses the treatment of groups of five (5) patients who received two (2) doses of ADXS11-001 at one (1) of three (3) doses, 1.0 x 109, 3.30 x 109 or 1.0 x 1010 cfu (bacteria) as IV infusions. All fifteen (15) treated patients received ampicillin beginning at five (5) days after each infusion. This trial was designed to assess the safety of ADXS11-001 in a population with recurrent, metastatic cervix cancer who had failed cytotoxic therapy comprised of radiotherapy, chemotherapy or both.
The agent was found to be administered safely with side effects consisting of a flu-like syndrome comprised of fever, nausea, chills, headache, myalgia, etc. This response is common to many immunotherapies and is believed to result from the release of chemical mediators of immunity called cytokines. Cytokine release characterizes what is termed an “innate” immune response. Very strong innate immunity can be associated with hypotension, and this was observed at the highest dose tested, resulting in no further dose escalation. All side effects, including hypotension, were resolved with symptomatic treatment and did not require the administration of antibiotics, except for two (2) cases of fever that persisted at seventy-two (72) hours and, per the protocol, ampicillin was given to these patients at that time. These fevers remitted upon antibiotic administration and both of these patients are still alive. Although not designed to assess efficacy, response and survival data was collected.
The median survival of cervix cancer patients who fail first line cytotoxic therapy, according to work conducted by the Gynecologic Oncology Group of the National Cancer Institute, is 180 days. The median survival in this trial was 347 days.
Historically, one (1) year survival in this disease is approximately 5%. In this study, one (1) year survival was 53%. Four (4) of the thirteen (13) patients evaluable for efficacy (30%) experienced tumor reductions. One (1) patient experienced a greater than 30% reduction of her tumor burden which is the criterion for a partial response. This patient received additional chemotherapy and surgery subsequent to ADXS11-001 and became tumor free for over sixteen (16) months, and is still alive at 903 days. The two (2) patients who experienced fever requiring antibiotics are alive at 804 and 935 days.
ADXS11-001 was safely administered in clinical use in a severely debilitated terminal cervix cancer population. Some indications of efficacy were observed, however the small number of treated patients does not allow for conclusions regarding efficacy to be made at this time.
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. ADXS11-001 is a therapeutic vaccine, like Dendreon's (NGM: DNDN) Provenge that treats active cancer, but at much lower cost, because it is not formulated for a specific patient.
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.
For further information on ADXS11-001, please visit: www.advaxis.com/lc.htm.
About Advaxis, Inc.
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: April 2009