Healthcare Industry News: Cytogen
News Release - April 17, 2007
Advaxis Completes Dosing and Enrollment of Third Cohort of Patients in Phase I/II Cervical Cancer Vaccine TrialNORTH BRUNSWICK, N.J.--(HSMN NewsFeed)--Advaxis, Inc. (OTCBB: ADXS ) has completed the enrollment and dosing of the third cohort of patients diagnosed with advanced, recurrent or progressive cervical cancer in its Phase I/II clinical trial of Lovaxin C. The current assessment by an independent safety panel has found that Lovaxin C, a modified Listeria-based live vaccine is safe, even in end-stage cancer patients, and dose escalation is ongoing.
The trial is currently designed to test 4 different doses in cohorts of 5 patients. Side effects experienced by patients included transient mild-moderate fever and chills and transient nausea, all of which usually resolved within hours of dosing. Advaxis has now begun the dosing in the 4th and last cohort of patients. The Company is required to have the results of each dosing from each cohort reviewed by the committee prior to continuing the study and increasing the dosage in patients. The primary endpoint of this work, which is being conducted in Israel, Serbia and Mexico, is to establish a maximal safe dose of Lovaxin C.
"This Phase I/II clinical trial is designed to show the safety of the Lovaxin therapy. As this trial is a first in man assessment of a live Listeria vaccine containing a cancer antigen we are employing a conservative model consisting of a priming dose followed by a single booster vaccination, which is the minimal immunization regimen. We have already shown at three different doses that Lovaxin C, can be safely administered to very late-stage cervical cancer patients and have observed interesting changes in the disease in certain treated patients. We are pleased to be entering our last cohort of patients," said Dr. John Rothman, VP of Clinical Affairs of Advaxis.
This is the first human study by Advaxis in its development of a new class of cancer therapies using the Company's broadly enabling Listeria technology platform. These therapies use modified Listeria to deliver tumor-specific antigen fusion proteins, which have the ability to generate a robust immune response involving simultaneous and multiple integrated immune mechanisms to produce an unusually strong and effective therapeutic immune response to existing cancers and other diseases. Unlike current products on the market, which are ineffective in women already infected with the human papilloma virus (HPV), the cause of cervical cancer, Lovaxin C is designed to treat women who have already developed this cancer as a result of the infection.
Based in North Brunswick, New Jersey, Advaxis is developing proprietary Listeria cancer vaccines based on technology developed by Dr. Yvonne Paterson, professor of microbiology at the University of Pennsylvania, and chairperson of Advaxis' Scientific Advisory Board. Advaxis' is developing therapeutic cancer vaccines that enhance the immune system's cancer-fighting abilities through its proprietary Listeria monoCytogenes based system, which utilizes two immunological mechanisms (Innate and Classical Immunity) to develop safer and more effective Listeria based cancer vaccines. Advaxis is the exclusive licensee of a patented broadly enabling Listeria platform technology that can elicit effective anti-tumor responses. Advaxis' lead Listeria vaccine candidate, Lovaxin C, targets cervical and head and neck cancers. Further Listeria vaccines in development target breast, ovarian and lung cancers. Advaxis has entered a Phase I/II clinical trial. The Listeria platform will also have applications in the fields of infectious disease and autoimmune disorders.
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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