NORTH BRUNSWICK, N.J.--(BUSINESS WIRE)-- Advaxis, Inc., (OTCBB: ADXS), the live, attenuated Listeria monocytogenes (Lm) immunotherapy company, has received formal permission from the Drugs Controller General India (DCGI) to conduct a Phase II clinical trial of ADXS11-001, the Company's flagship drug construct, among 110 women with advanced, metastatic cervical cancer that has progressed subsequent to treatment with cytotoxic therapy. 55 women will receive ADXS11-001 alone, 55 will receive a combined regimen of both ADXS11-001 and cytotoxic therapy.
Advaxis' Phase II clinical trial will provide a real-time survival assessment; making it possible to evaluate the effect of ADXS11-001 on survival compared to historical norms during the trial. Historically, even when given the most effective regimen tested to date, these patients had a median survival of approximately six (6) months with only five percent (5%) surviving one (1) year.
"This design greatly advances the clinical development of ADXS11-001 in a number of ways," said Dr. John Rothman, EVP of Science and Operations. "If we can duplicate the results of our Phase I or improve upon them with three (3) doses of our agent, and if we find our agent to improve the outcome in combination with chemotherapy, then we might be able to show ADXS11-001 to be a safe and effective therapeutic agent where no alternatives exist."
About the Drug Controller General of India
In India, clinical trials are regulated by the Drug Controller General of India (DCGI), who is responsible for assuring that all clinical trials comply with the requirements of the International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, as well as Good Clinical Practices. The ICH requirements ensure that the results of trials conducted in India can be used for regulatory review in the US and Europe.
About Advaxis Phase II Trial of ADXS11-001 in India
This clinical trial differs from Advaxis' Phase I trial in three significant ways: First, unlike Phase I in which two (2) doses of ADXS11-001 was administered, this Phase II will administer three (3) doses. Second, this randomized trial compares ADXS11-001 alone, to ADXS11-001 given in a combined regimen with platinum based chemotherapy. Independent research suggests that combined immuno- and chemo-therapy regimens may be more effective than single agent regimens. Third, the ADXS11-001 regimen has been reduced from a 30 minute 250 ml infusion followed by IV and oral antibiotics over an 11-day period to an 80 ml 15 minute infusion followed by a 7 day oral course of antibiotic, which is easier to administer.
Patients will be randomly assigned to receive either three (3) administrations of ADXS11-001 or a single dose of the immunotherapy, followed by cisplatin treatment and then followed by a three (3) course regimen of ADXS11-001. Various clinical and immunologic measures will be taken and survival will be followed for the life of the patient.
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 and E7 is one of the HPV proteins believed to be responsible. Doses of 1 x 109, 3.3 x 109 or 1 x 1010 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. One (1) year survival for these patients historically is approximately five percent (5%).
The Phase I trial of ADXS11-001 was intended to assess safety, and like all phase I trials, not powered for efficacy; and so, 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 (1) year survival was 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.
Conrad F. Mir
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