04/14/2010 - Advaxis, Inc., the live, attenuated Listeria monocytogenes (Listeria) immunotherapy company, initiated the Company’s first clinical trial site in its randomized, single blind, placebo-controlled, Phase 2 clinical trial of ADXS11-001 for the treatment of cervical intraepithelial neoplasia (CIN). The study is designed to assess the safety and efficacy of ADXS11-001 for the treatment of CIN grade 2/3 commonly known as cervical dysplasia.
The Institute for Women’s Health & Body in Wellington, Florida is Advaxis’ first clinical trial site in this multicenter study. The principal investigator at the Institute for the trial is Dr. Keith Aqua, MD – an experienced clinical investigator in the development of new therapies for women’s health. His center has two Florida sites with 84,000 active patients and conducts over 2,000 Pap smears, per month.
Numoda Corporation is Advaxis’ strategic partner in the conduction and execution of this trial. Numoda’s expertise in the administration of all aspects of clinical trials administration from initial data structures and site training to database closure and analysis is extensive and provides Advaxis with high quality clinical trials management.
In regards to the trial, Numoda Corporation CEO Mary Schaheen said, “We are proud to be involved with such innovative drug development. Our combined efforts will help bring effective treatment to women suffering from cervical intraepithelial neoplasia.”
“The initiation of our Phase II CIN program for ADXS11-001 is a major milestone for the development of live, attenuated Listeria vaccines,” commented Advaxis Chairman/CEO Thomas A. Moore. “Our goal is to demonstrate that for millions of American women, CIN can be treated safely and effectively without the pain and risks of surgery. Similarly, we hope to show we can immunize against the return of CIN in the future; something surgery cannot do."
About Cervical Dysplasia (CIN)
CIN is the precursor condition to cervix cancer, which is diagnosed in 450,000 American women annually. Progressive CIN is currently treated with surgery to prevent cancer from occurring; however, this treatment is associated with a number of problems, which include the development of an “incompetent cervix” i.e., a condition that prevents women from carrying a baby to full term. The typical CIN patient is a woman between 25 and 45 years of age. Although surgery is a viable short-term solution for the condition, it does not address the cause of the disease, which is a human papilloma virus (HPV) infection. Women who require surgery once may need it again. Current HPV vaccination products have not demonstrated effectiveness against active HPV infections.
About The Advaxis Phase I Clinical Trial
The Advaxis Phase I clinical trial was conducted in women with advanced cervix cancer who had progressed following cytotoxic therapy. In most cases, these women had been treated with multiple therapeutic modalities including surgery, radiation and chemotherapy. It is accepted that once these patients fail cytotoxic therapy there is little that can be offered to cure their disease or extend life. Historically, the median survival for these patients is approximately 180 days with only about 5% surviving one year. In the Advaxis Phase I clinical trial, the median survival was 347 days with 57% of patients surviving one year. More information on this clinical trial can be found in the published results of this trial (Vaccine 27 2009 3975–3983).
The strong efficacy signal seen in the Phase I trial of ADXS11-001 in advanced cervix cancer patients who had failed cytotoxic treatment, suggests that this agent should be useful in the treatment of CIN as well as cervix cancer, as both indications result from persistent HPV infection.
About Numoda Corporation
Numoda Corporation is a leading provider of clinical trial information and logistics services to promising life sciences companies. Numoda's services strengthen the business case for new therapies by ensuring efficient deployment of funds and immediate reporting for early assessment of progress to improve conditions for the acquisition of funding, licensing and partnering money for future success. The business offerings include business evaluation, budget projections and oversight, in conjunction with comprehensive management of clinical trials, patented information systems, logistics management and reporting tools with early transparency.
About Advaxis, Inc.
Advaxis is a biotechnology company developing proprietary, live, attenuated Listeria monocytogenes (Listeria) immunotherapeutics 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. The Company’s technology was developed by Dr. Yvonne Paterson, professor of microbiology at the University of Pennsylvania and chairperson of Advaxis’ scientific advisory board.
