First Patient Treated with Promising New Mesothelioma Therapy

February 11, 2013

517761_hospital_bc_laboratory_form_with_syringe_1.jpgA mesothelioma patient at the Memorial Sloan Kettering Cancer Center in New York was treated with a new therapy called GL-ONC1 for the first time on February 6, 2013. The patient is involved in a Phase I clinical trial, conducted to determine the efficacy of GL-ONC1 in malignant pleural effusions. An estimated 30% of lung cancer patients suffer from pleural effusions, which is a build-up of cancerous fluid between the lung and the wall of the chest cavity.

The therapy was developed by Genelux Corporation, which develops novel virus-based medications for cancer patients. GL-ONC1 is a single agent therapy that delivers both therapeutic and diagnostic capabilities. The diagnostic capabilities involve the use of a green fluorescent protein with deep-tissue imaging technologies, so tumors and circulating cancer cells can be specifically visualized. These imaging capabilities are non-invasive, and will help doctors more effectively diagnose cancers and aid in follow-up therapy monitoring and analysis of tumor biopsies.

The therapeutic aspect of the vaccine uses a modified Lister virus strain that is designed target, infiltrate, colonize, and ultimately destroy cancer cells. Unlike chemotherapy and radiation, the therapy does not harm healthy tissue and organs. The Lister virus has been used safely and successfully in millions of people in a vaccination against smallpox.

In pre-clinical trials, the modified Lister virus eliminated over 40 types of solid tumors. The first clinical trial for GL-ONC1 was conducted at a hospital in Surrey, England. In those patients, the vaccine was tolerated well and with minimum toxicity. The therapy showed positive preliminary evidence of anti-tumor activity in several types of tumors.

The association between viruses like the Lister strain and cancer degeneration was first acknowledged in the early 1900s. It wasn't until modern genetic engineering techniques were developed, however, that significant advancement has been made in virotherapy. Using these new techniques, scientists have been able to create new anti-cancer viruses by modifying existing ones known to be successful. The Lister strain is able to seek and enter cancer cells, which are present in pleural effusions, amplify, duplicate, and ultimately destroy the cancer cells.

The GL-ONC1 is administered intra-pleurally, which means it is injected directly into the affected lung cavity. The primary goal of these clinical trials is to determine what the recommended dosages should be. Secondary objectives include establishing the safety, tolerability, and feasibility of an intrapleural vaccine and to evaluate the appearance and response of the virus in tumors.

A maximum of 54 patients can potentially be enrolled in the GL-ONC1 trials, depending on the amount of dose levels that will be tested. Most patients will be subjected to video-assisted thoracic surgery along with pleural biopsies. This will enable doctors to use the diagnostic aspect of GL-ONC1, assessing for the green fluorescent protein in tumor cells and tissues. The surgery involves only a very small incision (less than an inch) into the chest wall, and enabled doctors to see the inside of the cavity, where the effusions build up.

The first patient at Kettering Cancer Center will be treated with GL-ONC1 and must complete 14 days of post-treatment evaluation before any additional patients may be treated. More information about the clinical trials, including guidance for how to enroll, can be found here. Currently, patients diagnosed with malignant pleural effusions are given a prognosis of only a few months, and treatment options include the use of catheters, pleurodesis, and pleurectomy. These treatment options are extremely invasive and, in the case of pleurectomies, quite dangerous and linked with significant morbidity and mortality.

Mesothelioma lawyers at Pintas & Mullins hope this new vaccine will successfully target and destroy cancer cells in malignant pleural effusions. Mesothelioma is almost exclusively caused by exposure to asbestos. If you or someone you love was diagnosed with mesothelioma, or any other asbestos-related illness, contact a skilled asbestos exposure attorney today for a free legal consultation.