First Patient Treated in Genelux Corporation Phase I Trial With GL-ONC1 at Memorial Sloan-Kettering Cancer Center
Published: Feb 06, 2013
SAN DIEGO, CA--(Marketwire - February 06, 2013) - 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.
About malignant pleural effusion
A pleural effusion is an abnormal amount of fluid in between the thin layers of tissue (pleura) lining the lung and the wall of the chest (pleural) cavity. If cancerous cells are found in this fluid, it is called a malignant pleural effusion. Lung cancer and breast cancer account for about 50-65% of malignant pleural effusions. Other common causes include pleural mesothelioma and lymphoma.
Mesothelioma is a rare cancer of the serous membranes, which enclose a number of organs throughout the midsection of the body. The most common type of mesothelioma, pleural mesothelioma, affects the serous membranes (lining) of the lungs. According to the National Cancer Institute (NCI), exposure to airborne asbestos particles increases one's risk of developing malignant mesothelioma. About 3,000 new cases of mesothelioma are diagnosed each year in the United States.
For more information about mesothelioma please visit the Mesothelioma Applied Research Foundation, www.curemeso.org, or the National Cancer Institute's Malignant Mesothelioma Home page, http://www.cancer.gov/cancertopics/types/malignantmesothelioma.
About non-small cell lung cancer
According to the American Cancer Society 2012 statistics, NSCLC is the most common type of lung cancer, comprising about 85% of all lung cancers. Squamous cell carcinoma, adenocarcinoma, and large cell carcinoma are all subtypes of NSCLC. Lung cancer is by far the leading cause of cancer death among both men and women. Each year, more people die of lung cancer than of colon, breast, and prostate cancers combined.
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 vaccinia virus-based technology platform that can be engineered to insert specific therapeutic genes for delivery and amplification of anti-cancer proteins and RNA into cancer cells without harming healthy cells. This platform also includes a bioluminescent diagnostic, green fluorescent protein (GFP). 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 vaccinia virus (Lister strain) that is currently under evaluation in multiple human clinical trials in the US and Europe. 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.
(1 ) http://lungcancer.about.com/gi/o.htmzi=1/XJ&zTi=1&sdn=lungcancer&cdn=health&tm=100&f=00&su=p284.13.342.ip_p1026.33.342.ip_&tt=2&bt=1&bts=1&zu=http%3A//www.ncbi.nlm.nih.gov/pubmed/19436206%3Fordinalpos%3D10%26itool%3DEntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum