New Mesothelioma Drug Dosage Recommendations Studied in Trial Tests

Earlier this month, the first new mesothelioma clinical trial of 2013 launched in New York when a team from Memorial Sloan-Kettering Cancer Center working in collaboration with the biopharmaceutical company Genelux administered a 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 “And we anticipate [the study] will take about a year to complete.”

Genelux 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 of the mesothelioma treatments currently in use are not selective enough to ignore healthy tissues, so patients often experience chemotherapy and radiation side effects such as nausea, rashes, and mouth sores. Scientists hope that GL-ONC1 will help patients avoid these and other treatment side effects.

So far, pre-clinical trials have left the researchers hopeful, and no major complications were noted during animal trials.

Subjects treated with GL-ONC1 maintained a healthy weight and food intake, while subjects not given the new drug developed cancer cachexia (weight loss). Furthermore, during the observation period, no treated animals developed infections or signs of toxicity. Among subjects, the most frequent side effects of this drug were grade 1 and 2 fatigue and fever.

Right now, at least three other trials are underway to test GL-ONC1. One study, hosted by Germany’s University Hospital in Tuebingen, is focusing on patients with peritoneal mesothelioma.

The focus in the Sloan-Kettering trial is pleural mesothelioma, the most common form of this type of cancer. Since other trials have shown that the drug is safe for use on humans, the Sloan-Kettering trial will focus on establishing dosing recommendations 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.

None of the patients will receive a placebo during this phase of testing. Later in the testing process, the drug will be compared to other mesothelioma treatment options.

“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.”

En route to its target, the immune system does not attack the virus. Because this drug is injected directly into the pleural lining of the lungs, it quickly reaches tumors and begins to attack mesothelioma cells.

Genelux scientists also modified the drug to contain a unique fusion protein known as GFP, which expresses a bright green glow when exposed to ultraviolet light. GFP allows oncologists to get a better understanding of tumor activity by providing non-invasive, real-time imaging capabilities.

Genelux expects the drug to be effective on its own, as well as as an addition to 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.

The team at Memorial Sloan-Kettering is hoping for roughly 54 patients to participate in the trial so that they can thoroughly test each of the dose levels.