SOURCE: Genelux

Genelux

May 31, 2012 09:15 ET

Genelux Corporation Announces Treatment of First Patient in Phase I/II Clinical Trial of GL-ONC1 in Advanced Peritoneal Cavity Cancers

Study Marks First Time Cancer Patients Are Treated With Oncolytic Vaccinia Virus in Germany

SAN DIEGO, CA--(Marketwire - May 31, 2012) - Genelux Corporation, a privately-held clinical-stage biopharmaceutical company focused on development and commercialization of best-in-class, vaccinia-virus-based oncolytic viral therapies and companion diagnostics for cancer, today announced that the first patient was treated on April 30, 2012 in a Phase I/II clinical trial of GL-ONC1 in patients with advanced peritoneal cavity cancers. The safety and dose-escalation study will evaluate GL-ONC1 administered intra-peritoneally as a single agent therapy, and will include a number of possible of cancer types -- potentially gastric, colon, liver, kidney, ovarian and pancreatic cancer, among others. Importantly, this is the first time that a vaccinia-based oncolytic viral therapy was administered to a human cancer patient in Germany.

"GL-ONC1, our leading product candidate, has been well-tolerated and shown encouraging results in early human trials against a number of solid tumor cancers. It is based on a novel product platform that delivers therapeutic and diagnostic constructs directly to tumors without harming healthy tissues or cells," said Dr. Aladar A. Szalay, founder and CEO of Genelux Corporation. "In this trial, we hope further to evaluate GL-ONC1's safety profile, dosing scheme and anti-tumor effects specifically within the peritoneal body cavity, and to explore whether, for such cancers, intra-peritoneal administration is the most effective means to reach and kill these cancer cells or tumor types."

The study is being conducted at University Hospital Tuebingen, in Tuebingen Germany, and may enroll up to 30 patients across two phases. Once a maximum tolerated dose (MTD) or Recommended Dose (RD) is determined for patients in the Phase I portion of the study, additional patients may be enrolled to conclude the Phase II portion of the trial. The endpoints of the trial include safety, dose optimization and anti-tumor effects as measured by RECIST and Choi criteria. For more information about the trial, please visit www.clinicaltrials.gov.

About Genelux Corporation

Headquartered in San Diego, California, Genelux Corporation is a privately held, clinical stage biopharmaceutical company dedicated to fundamentally changing the way in which cancer is diagnosed and treated. The company has developed a proprietary oncolytic virus-based technology platform featuring a companion optical imaging [luminescent/fluorescent] diagnostic capability on a therapeutic, replication-competent Lister strain vaccinia virus backbone. It is designed to selectively find and kill cancer cells without harming healthy tissues or cells. The platform can also be "customized" by inserting desired genes to effectively treat a variety of cancers and cancer-related conditions. The company is also incorporating advanced diagnostic deep-tissue imaging technologies into its viral platform to enable highly specific visualization of tumors and circulating cancer cells. GL-ONC1, the company's lead oncology product candidate, is an attenuated (Lister strain) vaccinia virus currently under evaluation in human clinical trials in Europe where they are officially sponsored by Genelux GmbH, a wholly owned subsidiary of Genelux Corporation. Additional US- and European-based trials are set to begin imminently. For more information please visit http://www.genelux.com.

Genelux Forward-Looking Statement

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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