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, 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 programme 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."
CIN is the precursor condition to cervix cancer, which is diagnosed in 450,000 American women annually.
The Advaxis phase-I clinical trial was conducted in women with advanced cervix cancer who had progressed following cytotoxic therapy.
Numoda Corporation is a leading provider of clinical trial information and logistics services to promising life sciences companies.
Advaxis is a biotechnology company developing proprietary, live, attenuated Listeria monocytogenes (Listeria) immunotherapeutics that deliver engineered tumour antigens, which stimulate multiple, simultaneous, immunological mechanisms to fight cancer.