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Advaxis Receives IRB Approval For Cervical Dysplasia Trial Of ADXS11-001
Posted by: admin in Pharmacy Drugs on November 14th, 2009
Advaxis, Inc., (OTCBB: ADXS), the live, attenuated Listeria monocytogenes (Lm) biotechnology company, has received approval from the New England Institutional Review Board (IRB) to enroll the first patient in a Phase II clinical trial of cervical dysplasia (cervical intraepithelial neoplasia or CIN).
The study will be a blinded, randomized comparison of ADXS11-001 versus placebo for the treatment of cervical dysplasia.
About the Phase II Clinical Trial
In this Phase II clinical trial, patients will receive three (3) administrations of ADXS11-001 at monthly intervals. Six (6) months after receiving their first dose, they will receive the standard of care for the treatment of their disease, which is surgery. Efficacy will be determined by comparing pre-treatment biopsy samples with surgical tissue samples. General observations to be made in the trial include that of patients’ health and well being, progression and state of disease, and clinical immunology.
The experimental protocol calls for thirty (30) patients in each group to be treated, for a total of one hundred, twenty (120) patients. ADXS11-001 dosage groups include two (2) doses that are lower than previously administered (5.0 x107 and 3.3 x108 cfu) and one at the lowest dose administered in Phase I (1.0×109 cfu).
About the New England IRB
New England IRB is an independent institutional review board for sponsors, CROs and individual researchers across the U.S. Its priority is to ensure safety of human subjects in clinical trials and we are committed to an ethical and thorough review process. Its Boards are comprised of highly qualified members with significant experience and knowledge in the ethical, scientific and legal aspects of clinical trials.
Founded in 1988 New England IRB was one of the first central IRBs established to meet the ethical review needs of the clinical trials industry. For studies ranging from one site to several thousand, NEIRB is focused on the protection of human subjects, responsiveness and service.
New England IRB has been audited by the U. S. Food and Drug Administration (FDA) and found to be in compliance with regulations.
Source
Advaxis