Advaxis Completes Dosing of Vanguard Patient Group in Phase II Cervical Dysplasia Clinical Trial
NORTH BRUNSWICK, N.J.--(BUSINESS WIRE)--Advaxis, Inc., (OTCBB: ADXS - News), the live, attenuated Listeria monocytogenes (Lm) biotechnology company, enrolled and has administered its initial dose to its third patient in its US Food and Drug Administration (FDA)-approved, phase II clinical trial in cervical intraepithelial neoplasia (CIN), commonly known as cervical dysplasia. This completes the enrollment of the vanguard group of patients for the first dosage group.
The clinical trial is a multicenter, randomized, placebo controlled, blinded clinical trial of ADXS11-001 -Advaxis' lead immunotherapeutic candidate. This trial is being conducted at the site by Dr. Keith Aqua, M.D. at the Institute for Women's Health & Body.
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 Design.
Advaxis has initiated the Company's randomized, single blind, placebo-controlled, Phase II clinical trial to assess the safety and efficacy of ADXS11-001 for the treatment of cervical intraepithelial neoplasia (CIN) grade 2+, which is late stage cervical dysplasia that requires surgery to prevent invasive cancer. The design that was approved by the FDA required that the first 3 patients in each of the dosage groups to be tested be fully treated and assessed before enrolling the remaining 37 patients in that group. The first 3 patients in the lowest dosage group have now been enrolled and dosing initiated.
About Cervical Dysplasia (CIN)
Cervical dysplasia is the precursor condition to cervix cancer, which is diagnosed in 450,000 American women annually. CIN 2+ (late stage 2 or stage 3) 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. Many women who require surgery once 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.
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