NORTH BRUNSWICK, N.J.--(BUSINESS WIRE)-- Advaxis, Inc., (OTCBB: ADXS), the live, attenuated Listeria monocytogenes (Lm) immunotherapy company, completes recruitment of the first group of patients in its US cervical dysplasia (CIN) phase II study of ADXS11-001 as required for the planned DMSB (safety board) meeting scheduled to be held January 11, 2011.
Following that meeting, the low dose portion of the study will complete recruitment and should be able to be reported on or about September 2011.
Advanced cervical dysplasia CIN leads to invasive cervical cancer. This trial follows from the promising findings in Advaxis’ ADXS11-001 phase I clinical trial in late stage cervical cancer.
About Advaxis’ Phase II ADXS11-001 Cervical Dysplasia Trial
The Advaxis phase II trial of ADXS11-001 for the treatment of CIN 2+ (late stage 2 and 3 CIN) includes a safety and efficacy assessments of the treatment by administering a three (3) dose regimen using 5x107, 3.3x108 or 1x109 cfu as an I.V. infusion at twenty-eight (28) day intervals. Patients are pretreated with over-the-counter anti-inflammatory and antihistamine agents to minimize any possible flu-like side effects and receive an oral course of ampicillin to eliminate any remaining Listeria beginning at 72 hours after each dose.
Women whose CIN requires surgical intervention are treated and observed for a six (6) month period before receiving surgery. Surgical specimens will be compared with pre-treatment biopsies to determine if the dysplastic cells that characterize CIN have been eliminated.
Assessments of human papilloma virus (HPV) and various immunologic parameters will be made throughout the trial to correlate viral and immunologic data with clinical responses. Durability of the immune response to the vaccine will be assessed at one (1) year after enrollment.
This study is a randomized single blind, placebo controlled study that is planned to enroll a total of 120 patients.
About Advaxis Phase I ADXS11-001 Cervical Cancer Trial
ADXS11-001 is a live, attenuated Listeria vaccine that targets the HPV oncoprotein E7. HPV is widely recognized as the cause of cervical cancer. One of three dose strengths (1x109, 3.3x109 and 1x1010 cfu) were administered twice to five (5) women; fifteen (15) in total. All patients had failed prior therapy including radiation and chemotherapy and had progressive, metastatic cancer. In such cases, no therapy has been found to be effective in extending survival compared to no treatment, at all.
Advaxis’ phase I ADXS11-001 cervical cancer trial was intended to assess safety. Like all phase I trials, it was not powered for efficacy; and as such, no conclusions can be made due to the small number of patients treated. However, the median survival in this trial was 347 days versus historical standards of 180 days or less. Further, the one-year landmark survival was 53% versus the historical experience of 5%.
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, Cancer Research – UK and the Department of Homeland Security. 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.
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