Mesothelioma Gene Therapy Trial Shows ‘Real Potential’

Gene therapy is moving closer to becoming part of standard-of-care treatment for pleural mesothelioma, according to the latest multicenter clinical trial.

The phase III trial, known as the INFINITE clinical research study, is designed to evaluate the intrapleural delivery of an investigational drug — a type of gene therapy — in combination with celecoxib and gemcitabine, anti-inflammatory and chemotherapy drugs, respectively.

Researchers hope to stop, or at least slow, the growth of mesothelioma tumor cells with the combination therapy.

“This is a very interesting concept,” oncologist Dr. Bernardo Goulart of the Seattle Cancer Care Alliance, told The Mesothelioma Center at Asbestos.com. “There is real potential here. We are excited about moving it forward.”

20 Years in the Making for Gene Therapy

Scientists have worked for more than 20 years to fine-tune gene therapy and make it an effective treatment for mesothelioma.

Success at the phase III level — increasing survival rates — could signal the culmination of decades of development.

“The goal here is to get definitive answers, not a suggestion, as to whether the new treatment is better than [current] standard of care,” said pulmonary oncologist Dr. Dan Sterman at New York University Langone Medical Center. “The hope is we may have a new treatment option.”

Standard of care today remains a combination of chemotherapy, radiation and resection, which has not been effective overall.

Less than a third of the patients with the disease qualify for the surgical option.

Sterman has been a longtime pioneer in the development of gene therapy for mesothelioma, stemming from his years at the University of Pennsylvania Abramson Cancer Center.

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Modified Virus Triggers Anti-Tumor Response

The investigational drug is a genetically engineered adenovirus that triggers the anti-tumor effects of interferon, a naturally occurring protein that destroys tumor cells.

It is injected directly into the pleural space through a catheter and works by helping the body produce more of the protein.

The official name of the therapy is Adenovirus-Delivered Interferon Alpha-2b, often referred to as rAd-IFN.

“We’re hoping the triple-drug combination will demonstrate a significant improvement in survival well beyond standard-of-care treatment,” Sterman said.

Investigators are hoping to enroll at least 300 patients through more than a dozen sites.

Lead investigators and sites in the U.S. already include:

The Seattle Cancer Care Alliance, with Goulart as the investigator, is one of a few more sites expected to begin accepting patients for the trial in the coming weeks.

Patients also are being accepted at centers in Poland, Germany, Australia, France and the United Kingdom. Trizell, a gene therapy company with facilities in the UK and Finland, is sponsoring the clinical trial.

Who Qualifies for the INFINITE Clinical Trial?

To qualify for the INFINITE clinical trial, mesothelioma patients must have already failed a minimum of one and a maximum of two treatment regimens.

Enrollees will be randomized 1-1 for the gene therapy treatment or the control group, which will allow investigators to compare the effectiveness of the treatment.

The gene therapy drug will be given only once, delivered directly into the pleural cavity.

Both groups will receive the celecoxib and gemcitabine.

The celecoxib is given orally twice daily for the first 14 days of the study. Gemcitabine will be given intravenously on days first and eighth day of a repeating three-week cycle until disease progression or withdrawal from the study.

Following Earlier Success

One reason for the optimism going into phase III was the success in earlier phases. In one phase II trial, the disease control rate was 87.5% for patients who either had failed standard chemotherapy or were newly diagnosed.

Among those using it as second-line treatment, there was a three-year survival rate of 20% and a median survival of 17 months.

“A phase III trial gives us the possibility of having another important drug in our armamentarium with potentially proven benefits,” Sterman said.

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