New Trial Tests Dosage Recommendations for New Drug
The first new mesothelioma trial of 2013 launched earlier this month in New York.
In collaboration with the biopharmaceutical company Genelux, a Memorial Sloan-Kettering Cancer Center team administered the trial drug — GL-ONC1 — to the first of what they hope to be several dozen patients.
“We have screened three patients to date,” Ulrike Szalay, Genelux Vice President of Strategic Planning and International Communications, told Asbestos.com. “And we anticipate [the study] will take about a year to complete.”
The corporation describes GL-ONC1 as an engineered virus that is programmed to “locate, enter, colonize and destroy cancer cells without harming healthy tissues or organs.”
Many currently used mesothelioma treatments aren’t selective enough to leave healthy tissues alone. That’s why patients often experience nausea and digestive issues during chemotherapy, and rashes and mouth sores during radiation therapy. If approved, GL-ONC1 could help patients avoid such side effects.
Pre-clinical trials support this hypothesis. During animal trials, researchers noted no major complications.
Treated subjects maintained a healthy food intake and weight, while untreated subjects developed cancer cachexia (progressive weight loss). Additionally, none of the treated animals developed infections or signs of toxicity during the observation period. The most frequently reported adverse events were grade 1 and 2 fatigue.
At least three other GL-ONC1 trials (for various malignancies) are currently underway. One of these studies, hosted by the University Hospital in Tuebingen, Germany, is recruiting peritoneal mesothelioma patients as part of their peritoneal cavity cancer focus group.
But in the new Memorial Sloan-Kettering trial, the focus is on pleural mesothelioma, the most common form of the asbestos-caused cancer. And since other trials have shown that the drug is safe for human use, the MSKLC trial will focus on finding a safe dose for mesothelioma patients.
“A safety monitoring period will follow the first patient in each new cohort after he/she is treated, to observe safety and tolerability — in case there should be any unforeseen acute toxicity,” Szalay explained.
During this phase of testing, none of the patients will receive a placebo. The comparison of the drug to other mesothelioma treatment options comes later in the testing process.
GL-ONC1’s Role in Mesothelioma Treatment
“In preclinical testing, the virus has efficiently eliminated more than 40 types of solid human tumors,” researchers assert. “Scientists at Genelux have modified this virus to increase its safety, tumor selectivity and anti-tumor activity without limiting its ability to replicate in cancer cells.”
The virus appears to successfully navigate through the body’s immune response to reach its tumor target. And because it is injected directly into the pleural lining of the lungs, it takes a very short amount of time to reach the tumors and begin attacking the mesothelioma cells.
To make it an even more useful tool in the search for a cure, Genelux scientists also modified it to carry a unique fusion protein known as GFP (green fluorescent protein). This unique compound — initially isolated from a jellyfish — expresses a bright green glow when exposed to ultraviolet light.
GFP provides non-invasive, real-time imaging capabilities to help oncologists get a better understanding of the activity in the tumor. It also makes it easier for doctors to analyze microscopic cell features, assign a stage to the tumors and monitor treatment.
Genelux expects the drug to work efficiently on its own, as well as in conjunction with other therapies.
“GL-ONC1 can be combined synergistically with other therapies, including chemotherapy and/or radiation. In fact, Genelux is currently conducting a Phase I clinical trial in head and neck cancer at UCSD — combining GL-ONC1 with chemotherapy and radiation therapy,” Szalay shared.
As the Memorial Sloan-Kettering trial progresses, more than 50 additional patients can join in the testing. (The team is hoping for roughly 54 patients to thoroughly test each of the dose levels.) For more information on joining the trial, see the National Cancer Institute’s study detail page.