SAN DIEGO, CA -- (Marketwire) -- 02/06/13 -- Genelux Corporation, a clinical-stage biopharmaceutical company developing vaccinia virus-based cancer therapies and companion diagnostics, today announced that researchers at Memorial Sloan Kettering Cancer Center (MSKCC) in New York treated the first patient in a Phase I clinical trial of GL-ONC1 in people with malignant pleural effusion, a complication that occurs in about 30 percent of lung cancers.(1) The safety and dose-escalation study will, for the first time, evaluate GL-ONC1 administered through the lung cavity (intra-pleurally) as a single agent therapy. Patients enrolled in the trial may have one of a number of possible cancer types such as malignant pleural mesothelioma or non-small cell lung cancer (NSCLC). Dr. Valerie W. Rusch, one of the world's leading thoracic surgeons and experts in mesothelioma, serves as Principal Investigator of the MSKCC-sponsored clinical trial.
"We are very pleased that researchers at MSKCC have initiated this important trial," said Dr. Aladar A. Szalay, founder and CEO of Genelux Corporation. "For the first time, this study will allow us to examine the feasibility and effects of administering GL-ONC1 intra-pleurally to some of the most aggressive cancers of the thoracic cavity -- including mesothelioma and non-small cell lung cancer. GL-ONC1 delivers therapeutic and diagnostic capabilities (via green fluorescent proteins) simultaneously and directly to tumors without harming healthy tissues or cells. It has been well-tolerated and shown encouraging results in early human trials against a number of solid tumor cancers," he added.
"Particularly in a rare disease with only one approved regimen the Foundation encourages all patients to consider participation in clinical trials," said Mary Hesdorffer, Nurse Practitioner and Executive Director of the Mesothelioma Applied Research Foundation, a nonprofit support group providing education, patient assistance and advocacy efforts aimed at ending the suffering caused by mesothelioma. "Novel approaches based upon newly developed scientific strategies may lead to more effective treatments and ultimately a cure in this rare and aggressive disease," she added.
The primary goal of the trial is to establish a recommended dose of GL-ONC1, when administered intrapleurally to patients with malignant pleural effusion, which is primarily attributable to NSCLC, malignant pleural mesothelioma (a cancerous tumor of the lining of the lung and chest cavity), and other cancers. Secondary objectives include the feasibility, safety and tolerability of intrapleural vaccinia virus; the detection of virus in body fluids; evaluation of viral appearance in tumors; evaluation of anti-vaccinia virus immune response (e.g. antibody responses) and evidence of anti-tumor activity.
The total number of patients studied will depend on the number of dose levels tested, with a possibility of up to 54 to be enrolled. Importantly, most patients will undergo Video-Assisted Thoracic Surgery (VATS) with pleural biopsies, allowing doctors to use GL-ONC1 as a diagnostic agent to assess for green fluorescent protein (GFP) viral expression in tumor(s) and surrounding tissues. 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; clinical trial identifier number NCT01766739.
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