Genelux Corporation Announces Early Results of a Phase I/II Clinical Trial of Virotherapeutic GL-ONC1 in Advanced Peritoneal Cavity Cancers
Published: Nov 01, 2012
SAN DIEGO, CA--(Marketwire - November 01, 2012) - Genelux Corporation, a clinical-stage biopharmaceutical company developing vaccinia virus based oncolytic cancer therapies and companion diagnostics, announced early results of the first patient cohort treated in a Phase I/II clinical trial with GL-ONC1, its leading virotherapeutic product candidate, in patients with advanced peritoneal cavity cancers. As presented at the 8th World Congress on Peritoneal Surface Malignancies in Berlin, Germany, GL-ONC1 was found to be clinically well tolerated when applied directly into the peritoneal cavity. Further results also directly display profound infection and lysis (cell rupture resulting in cancer cell death) of malignant cells being present in the peritoneal fluid of these GL-ONC1 treated cancer patients.
"Despite the fact that we are still in the early stages of our trial, we have seen encouraging results across the first patient group, including evidence of efficient replication of viral progeny over a prolonged period of time," said Dr. Ulrich M. Lauer, the study's principal investigator from the Dept. of Gastroenterology of the University Hospital of Tuebingen, Germany. "This replication allows GL-ONC1 to rapidly infect and spread through cancer cells. We have also observed effective cancer cell lysis as evidenced by the detection of marker proteins released into the peritoneal fluid of GL-ONC1 treated patients. For these reasons, direct application of GL-ONC1 into the peritoneal cavity could be of great advantage to patients with peritoneal metastases," said Dr. Lauer.
This safety and dose-escalation study is evaluating GL-ONC1 administered intra-peritoneally as a single-agent cancer virotherapy with a number of particularly aggressive cancers including gastric, colon, pancreatic, liver, and ovarian often metastasizing into the peritoneal cavity. Since April 2012, four patients have received a total of 8 infusions, including three patients in the first dose cohort at 1x10(7) infectious viral particles (defined as the lowest dose cohort), and one patient to date in the second cohort at 1x10(8) infectious virus particles.
"GL-ONC1, our leading product candidate, has been well-tolerated and shown encouraging results in early human trials against a number of solid tumors," said Dr. Aladar A. Szalay, founder and CEO of Genelux Corporation. "It is based on a novel product platform that delivers therapeutic and diagnostic constructs directly to tumors without harming healthy tissues or cells. As we go through the Tuebingen trial's dose escalation scheme, we will further evaluate GL-ONC1's safety profile and anti-tumor effects and determine whether intra-peritoneal administration is the most effective means to reach and kill these aggressive tumor types," he added.
This study 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 (NCT01443260).
Genelux's lead product candidate, GL-ONC1, is a systemically administered virotherapy that preferentially enters and lyses tumors, sparing healthy cells, while activating the body's immune response against cancer. It can be used as a monotherapy, "customized" by inserting desired genes to most effectively treat a variety of cancers, or in combination with chemotherapy and radiation. Moreover, it carries Green Fluorescent Protein (GFP) for imaging of cells that can be used as an aid in diagnosis and cancer staging. Genelux is now conducting a number of clinical trials with GL-ONC1 as a monotherapy and in combination with radiation and chemotherapy to treat various solid tumors. These studies in Europe and in the US have demonstrated that GL-ONC1 is well tolerated at therapeutic dose levels with evidence of anti-tumor activity.
About Genelux Corporation
Headquartered in San Diego, California, Genelux Corporation is a privately held, clinical stage biopharmaceutical company with a mission to fundamentally change 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 company is also incorporating advanced diagnostic deep-tissue imaging technologies into its viral platform to enable highly specific visualization of tumors and circulating tumor cells. GL-ONC1, the company's lead oncology product candidate, is currently under evaluation in human clinical trials in Europe (sponsored by Genelux's wholly owned subsidiary, Genelux GmbH) and in the US. Genelux is also conducting a veterinary clinical trial in the US with its oncolytic vaccinia virus, V-VET1, in canine cancer patients with various measurable malignancies.
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.