SAN DIEGO, June 14 2012 — Genelux Corporation, a clinical-stage biopharmaceutical company developing vaccinia virus-based oncolytic (cancer-killing) therapies and companion diagnostics for cancer, today announced that the first patient has been dosed in a Phase I clinical trial of GL-ONC1 combined with chemoradiotherapy in patients with locoregionally advanced head and neck cancers. The study will evaluate whether GL-ONC1, administered intravenously as a combination therapy with cisplatin and radiotherapy (standard of care), may be safely given to patients with primary, non-metastatic disease, who have not undergone prior therapy or surgical interventions.
To date we have observed GL-ONC1 only as a single agent therapy in cancer patients, and it has proven to be safe and well-tolerated with early signs of anti-tumor activity, said Aladar A. Szalay, Ph.D., founder and CEO of Genelux Corporation. Through this first combination trial, we hope to evaluate which head and neck cancer subtype(s) may be most responsive to GL-ONC1 and to assess potential synergistic effects of combination therapy that may benefit people with this type of cancer.
This trial is testing a promising and novel treatment paradigm for advanced tumors that have a poor prognosis with standard therapy, and is a quintessential example of bench-to-bedside research taking place at UCSD, said Principal Investigator Dr. Loren K. Mell M.D. Our hope is that this therapy will ultimately advance into controlled clinical trials and lead to a substantial improvement in the treatment of head and neck and other cancers.
The study is being conducted at the Rebecca and John C. Moores Cancer Center at the University of California, San Diego (La Jolla, California), and will enroll up to 24 patients. The endpoints of the trial include safety, dose optimization and anti-tumor effects as measured by RECIST 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 also 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 planned and will begin in the near future. 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.