News
August 29, 2005
Advaxis’ Listeria Cancer Vaccine Shows Strong Safety Profile In Toxicology Studies
Princeton, NJ, (BUSINESS WIRE) Advaxis, Inc (OTCBB: ADXS) announced today that it has successfully completed its pre-clinical toxicology studies of Lovaxin C, its Listeria 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 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 program and the safety of Lovaxin C. As we had expected, Lovaxin C, which is made from attenuated 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 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. 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. 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. Advaxis focuses on commercializing the innovative vaccine technology developed by Dr. Yvonne Paterson in the Department of Microbiology at the University of Pennsylvania. 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 cancer vaccines. Advaxis is the exclusive licensee of a patented broadly enabling innate immunity platform technology, which is based on the usage of the attenuated bacteria Listeria Monocytogenes, that, when combined with classical antibody and cellular immune mechanisms, can elicit more effective anti-tumour responses. Advaxis� lead vaccine candidate, Lovaxin C, targets cervical and head and neck cancers. Further vaccines in development target breast, ovarian and lung cancers. Advaxis is presently in the pre-clinical stage of development with Lovaxin C and anticipates this vaccine will enter Phase I clinical trials in early 2005. The Listeria platform will also have applications in the fields of infectious disease and autoimmune disorders. This news release does not constitute an offer to sell or the solicitation of an offer to buy any security. The securities issued in the private placement have not been registered under the Securities Act of 1933, as amended, or applicable state securities laws and may not be offered or sold in the United States absent registration under the Securities Act of 1933, as amended, and applicable state securities laws or an applicable exemption from registration requirements. The Company has agreed to file a registration statement covering the resale of the securities issued in the private placement.
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.
Company Contact:
J. Todd Derbin
CEO & President
Advaxis, Inc.
212 Carnegie Center
Princeton, NJ 08540
derbin@advaxis.com
(609) 895-7150
Jennifer K. Zimmons, Ph.D.
Investor Relations
Strategic Growth International
150 East 52nd St., 22nd Fl.
New York, NY 10021
jzimmons@sgi-ir.com
(212) 838-1444