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Advaxis Receives IRB Approval for Cervical Dysplasia Trial Of ADXS11-001.


Clinical Trial Scheduled to Commence January 2010

NORTH BRUNSWICK, N.J. -- Advaxis, Inc., (OTCBB OTCBB

See OTC Bulletin Board (OTCBB).
: ADXS), the live, attenuated Attenuated
Alive but weakened; an attenuated microorganism can no longer produce disease.

Mentioned in: Tuberculin Skin Test


attenuated

having undergone a process of attenuation.
 Listeria Listeria /Lis·te·ria/ (lis-ter´e-ah) a genus of gram-negative bacteria (family Corynebacterium); L. monocyto´genes causes listeriosis.

Lis·te·ri·a
n.
 monocytogenes (Lm) biotechnology company, has received approval from the New England Institutional Review Board (IRB IRB

See: Industrial Revenue Bond
) to enroll the first patient in a Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored
phase II
 of cervical dysplasia Cervical dysplasia
Dysplasia is the abnormal growth of the epithelial cells. This is what a Pap smear will detect in the cervix.

Mentioned in: Pelvic Exam

cervical dysplasia
 (cervical intraepithelial neoplasia cervical in·tra·ep·i·the·li·al neoplasia
n.
Dysplastic changes beginning at the squamocolumnar junction in the uterine cervix that may be precursor to squamous cell carcinoma.
 or CIN CIN cervical intraepithelial neoplasia.
Cervical intraepithelial neoplasia (CIN)
A term used to categorize degrees of dysplasia arising in the epithelium, or outer layer, of the cervix.
).

The study will be a blinded, randomized ran·dom·ize  
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment.
 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 (1.0x109 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 FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) and found to be in compliance with regulations. We are qualified to serve as the IRB for federally funded research. For further information, please feel free to call 781-431-7577 or email info@neirb.com.

About the Company

Based in North Brunswick, New Jersey, Advaxis is developing proprietary Listeria monocytogenes (Lm) cancer vaccines based on technology developed by Dr. Yvonne Paterson, professor of microbiology at the University of Pennsylvania (body, education) University of Pennsylvania - The home of ENIAC and Machiavelli.

http://upenn.edu/.

Address: Philadelphia, PA, USA.
 and chairperson of Advaxis' scientific advisory board. Advaxis is developing attenuated live Lm vaccines that deliver engineered tumor antigens, which stimulate multiple simultaneous immunological mechanisms to fight cancer.

In a recent Advaxis Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained
phase I
, a live Lm vaccine directed against the tumor-associated antigen HPV-16-E7 was safely administered to fifteen (15) women with recurrent, advanced, metastatic cancer of the cervix. Although this first trial of an Lm vaccine in humans was not designed or powered to prove efficacy, Advaxis believes an efficacy signal was observed that will be further explored in two (2) planned Phase II trials in the US and India in cervical cancer and its predecessor condition, cervical intraepithelial neoplasia (CIN). Advaxis now has nine (9) distinct cancer fighting constructs in various stages of development, both directly and with academic collaborators. For further information on the Company, please visit: www.advaxis.com.

Forward-Looking Statements

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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Date:Oct 28, 2009
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