Advaxis' Listeria Cancer Vaccine Shows Strong Safety Profile In Toxicology Studies.PRINCETON, N.J. -- Advaxis, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). : ADXS) announced today that it has successfully completed its pre-clinical toxicology studies of Lovaxin C, its 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. Cancer Vaccine, for treatment of cervical and head and neck cancers. The results from these studies complete the toxicology package necessary for the initiation of its Phase I/II study in cervical cancer Cervical Cancer Definition Cervical cancer is a disease in which the cells of the cervix become abnormal and start to grow uncontrollably, forming tumors. patients. This trial will be the first-in-man assessment of a Listeria monocytogenes based live cancer vaccine. Toxicology and assay assessments were performed at Stillmeadow Inc, Lark Laboratories and Nova Laboratories in conformance with the Good Laboratory Practice procedures that are required by U.S. and European regulatory authorities. Toxicology testing was performed on mice in both single and repeated dosing regimens. Commenting on the completion of this work, John Rothman, Ph.D, Advaxis' Vice President of Clinical Development stated, "We are pleased to report the successful completion of our preclinical toxicology preclinical toxicology (prēˈ·kliˑ·ni·k Alive but weakened; an attenuated microorganism can no longer produce disease. Mentioned in: Tuberculin Skin Test attenuated having undergone a process of attenuation. Listeria, has been proven to be far less toxic than wild type Listeria monocytogenes. Further, no evidence of toxicity was reported at levels that correspond to the doses in our upcoming human clinical studies. This third-party data confirms the results we had already observed in our laboratories. It is interesting to note that we tested the safety of Lovaxin C in a species of mouse known to be most sensitive to Listeria toxicity, thus assessing toxicity in the worst case. Additionally, we have confirmed the susceptibility of Lovaxin C to many common antibiotics, which assures us of the ability to maximize efficacy with regimens that are completely safe, even in immunocompromised immunocompromised /im·mu·no·com·pro·mised/ (-kom´pro-mizd) having the immune response attenuated by administration of immunosuppressive drugs, by irradiation, by malnutrition, or by certain disease processes (e.g., cancer). cancer patients." J. Todd Derbin, Chief Executive Officer of Advaxis commented, "Achieving this milestone takes us one step further with our Listeria based cancer vaccines Cancer vaccines A treatment that uses the patient's immune system to attack cancer cells. Mentioned in: Pancreatic Cancer, Exocrine . Further, given that our Company is based on platform technology and that Lovaxin will be used to treat a variety of other types of cancers, we find this news especially encouraging." Advaxis plans to initially develop Lovaxin C for patients with cervical and head and neck cancers, which both express the antigen HPV-E7, against which Lovaxin C targets an unusually strong cytotoxic immune response immune response n. An integrated bodily response to an antigen, especially one mediated by lymphocytes and involving recognition of antigens by specific antibodies or previously sensitized lymphocytes. . A phase I/II study for late-stage cervical cancer patients is planned for late 2005 followed by Phase II protocols in both cervical and head and neck cancers in late 2006. About Advaxis: Advaxis is based in Princeton, New Jersey
Princeton, New Jersey is located in Mercer County, New Jersey, United States. Princeton University has been sited in the town since 1756. . Advaxis is developing proprietary Listeria cancer vaccines based on the vaccine technology developed by Dr. Yvonne Paterson in the Department 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. . Advaxis is developing therapeutic cancer vaccines that enhance the immune system's cancer-fighting abilities. Advaxis, through its proprietary Listeria monocytogenes based system, is utilizing 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 based on the use of attenuated bacteria Listeria monocytogenes, 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 is entering a Phase I/II clinical trial in late 2005. The Listeria platform will also have applications in the fields of infectious disease Infectious disease A pathological condition spread among biological species. Infectious diseases, although varied in their effects, are always associated with viruses, bacteria, fungi, protozoa, multicellular parasites and aberrant proteins known as prions. and autoimmune disorders Autoimmune Disorders Definition Autoimmune disorders are conditions in which a person's immune system attacks the body's own cells, causing tissue destruction. . 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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