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Tumor Eradication Article Published by Cancer Research
Date:11/12/2007

Preclinical results make compelling case for clinical testing in human

cancer patients

SAN DIEGO, Nov. 12 /PRNewswire/ -- In its Oct. 15 issue, Cancer Research published a peer-reviewed article from Genelux Corporation describing successful eradication of human breast cancer tumors in animals using GL-ONC1, a novel oncolytic virus developed by Genelux scientists. These promising results make a compelling case for the use of GL-ONC1 in human cancer patients. Clinical trials are scheduled to begin in the near future.

"We believe this research represents a significant advance in tumor therapy and diagnosis," said President and CEO Aladar A. Szalay, PhD, an internationally-recognized scientist who founded Genelux Corporation in 2001.

The article, titled "Eradication of Solid Human Tumors in Nude Mice with an Intravenously Injected Light-Emitting Oncolytic Vaccinia Virus," documents animal studies that have resulted in complete eradication of human breast tumors without any observed toxicity using a single intravenous injection of GL-ONC1. In the studies, GL-ONC1 located and replicated selectively within tumors, leading to successful tumor destruction. Scientists were able to monitor tumor regression and elimination in real time using a light-emitting fusion protein encoded in the virus.

GL-ONC1 also stimulated the body's own natural defenses to fight the cancer. After administration, tumor-specific viral colonization enables the immune system to recognize tumors as foreign elements and activate defense mechanisms to fight them. These increased innate and adaptive immune responses further contribute to the regression and eventual eradication of the tumor.

This research was conducted in collaboration with scientists at the National Institutes of Health, Department of Transfusion Medicine and Center for Information Technology, in Bethesda, Maryland; and the Virchow Center for Experimental Biomedicine at the Institute of Biochemistry and Institute for Molecular Infection Biology at the University of Wurzburg in Germany.

Background

GL-ONC1 is a genetically stable oncolytic virus strain designed to locate, enter, colonize and destroy cancer cells without harming healthy tissues or organs. GL-ONC1 is based on vaccinia virus, which was used safely in millions of people as the vaccine against smallpox. Scientists at Genelux have modified this virus to increase its safety, tumor selectivity and anti-tumor activity without limiting its ability to replicate in cancer cells. GL-ONC1 also carries a unique fusion protein designed to provide non-invasive, real-time imaging capabilities, including tumor diagnosis and localization, microscopic analysis of tumor biopsies, cancer staging and follow-up treatment monitoring.

The safety and efficacy demonstrated in preclinical studies, along with vaccinia virus' well-documented safety record as a vaccine against smallpox, make GL-ONC1 a promising candidate for clinical trials. Clinical trials are expected to begin in the near future in the U.S. and Europe.

To read the abstract, visit: http://cancerres.aacrjournals.org/cgi/content/abstract/67/20/10038. For company information, visit: http://www.genelux.com.

Statements made about Genelux Corporation, other than statements of historical fact, reflect Management's current beliefs and assumptions founded on the data and information currently available to us. Statements of the company's progress, results, timing of pre-clinical and clinical trials and projections for product pipelines are examples of forward-looking statements. By definition, such undertakings involve risks, uncertainties and assumptions, and are subject to a number of such factors that could cause actual results to differ substantially from statements made, including but not limited to: risks associated with the success of clinical trials, research and development programs, regulatory approval processes for clinical trials, competitive technologies and products, patents, inception and/or continuation of corporate and other strategic partnerships and the need for additional funding or financing.


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