NORTH BRUNSWICK, N.J.--(BUSINESS WIRE)-- Advaxis, Inc., (OTCBB: ADXS), the live, attenuated Listeria monocytogenes (Lm) biotechnology company, has dosed the first patient in its US Food and Drug Administration (FDA)-approved, phase II clinical trial in cervical intraepithelial neoplasia (CIN), commonly known as cervical dysplasia.
The clinical trial is slated to be a multicenter, randomized, placebo controlled, blinded clinical trial of ADXS11-001 –Advaxis’ lead immunotherapeutic candidate. The dosing was administered at the site of Dr. Keith Aqua, M.D. of the Institute for Women’s Health & Body.
“Dosing the first patient is a significant milestone for our company,” commented Advaxis Chairman/CEO Thomas A. Moore. “It is a highly awaited development amongst all Advaxis and immunotherapy followers, at large; following the recent Dendreon Corporation (Nasdaq: DNDN) FDA approval. We look forward to completing and reporting the first dosing leg over approximately the next fifteen (15) months.”
About the Institute for Women’s Health & Body
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, M.D. – an experienced clinical investigator in the development of new therapies for women’s health. His center has two (2) Florida sites with 84,000 active patients and conducts over 2,000 Pap smears, per month.
About Advaxis’ Cervical Dysplasia (CIN) Trial
Advaxis has initiated the Company’s first clinical trial site in its randomized, single blind, placebo-controlled, Phase II 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.
About Cervical Dysplasia (CIN)
Cervical dysplasia 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 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.
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