Doctors at Memorial Sloan Kettering Cancer Center in New York have treated the first patient in a new trial that could offer hope to people with malignant mesothelioma and one of its most common complications.
The trial is a dose-escalation test of a new drug called GL-ONC1, a genetically modified vaccinia virus produced by the California biopharmaceutical company Genelux Corporation. GL-ONC1 is designed to be both therapeutic – actually treating the cancer – and diagnostic (via green fluorescent proteins) in people with mesothelioma and non-small cell lung cancer who have a buildup of lung fluid called malignant pleural effusion.
In the new mesothelioma trial, which is sponsored by Memorial Sloan Kettering in collaboration with Genelux, GL-ONC1 will be administered in a single dose into each participant’s intra-pleural cavity, the space between the lungs and the membrane that surrounds them. About 30% of patients with lung-related cancers (including mesothelioma) experience a build-up of fluid in this area. When cells in the fluid turn cancerous, it is known as malignant pleural effusion. As many as 54 of these patients will be the first recipients of intra-pleural GL-ONC1.
“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,” said Dr. Aladar A. Szalay, found and CEO of Genelux, adding that GL-ONC1 “has been well-tolerated and shown encouraging results in early human trails against a number of solid tumor cancers”.
The goal of the study is to establish a recommended dose for GL-ONC1 when given intra-pleurally to patients with malignant pleural effusion due to mesothelioma or another lung cancer. Doctors will also be assessing the safety and tolerability of the altered virus and will test for its presence in body fluids and tumor tissue. Patients enrolled in the trial will undergo Video-Assisted Thoracic Surgery (VATS) with pleural biopsies to see how much of the green fluorescent protein (GFP) produced by the virus ends up in the tumor and surrounding tissues. This can help doctors track the growth of a tumor.
The trial of GL-ONC1 is now recruiting participants. Dr. Valerie Rusch, a leading thoracic surgeon and mesothelioma expert at Memorial Sloan Kettering, serves as Principal Investigator.
Intra-pleural Administration of GL-ONC1, a Genetically Modified Vaccinia Virus, in Patients with Malignant Pleural Effusion: Primary, Metastases and Mesothelioma”, national Institutes of Health Clinical Trial website.