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Highly Anticipated Gene Therapy Clinical Trial for Mesothelioma Opens Worldwide

A Phase III study of a novel gene therapy known as TR002 has launched. The open-label, randomized, parallel group study is set to recruit up to 300 patients with malignant pleural mesothelioma (MPM) who have failed first-line standard of care chemotherapy.

Developed by Trizell Ltd. (Trizell), TR002 is an interferon alfa-2b gene therapy that triggers the pleiotropic anti-tumor effects of interferon, which is a naturally occurring protein the body uses to fight cancer. TR002 is followed by Gemzar (gemcitabine), a type of chemotherapy drug used to treat non-small cell lung cancer as well as cancers of the ovaries, breast, bladder, and pancreas.

Mesothelioma is an aggressive cancer that affects the pleural (outer) membrane of the lungs. The disease is caused by inhalation of asbestos fibers and it can take decades to develop. There is no cure mesothelioma. However, diagnosis and treatment options have continued to expand and improve, leading to better outcomes.

Today, gene therapies are considered promising therapies applicable to a broad range of difficult to treat diseases such as mesothelioma. To date, more than 2,335 gene therapy clinical trials have been completed, were ongoing or approved (but not started) worldwide. The TR002 study will include sites around the world including Europe, Australia, Russia and the U.S.

According to a Trizell press release, a previous Phase II study of TR002 at Penn Medicine’s Abramson Cancer Center included 40 mesothelioma patients who were newly diagnosed or failed standard chemotherapy (Pemetrexed, Cisplatin). Patients showed an overall disease control rate of 87.5%. The second line treatment cohort showed an almost doubling of median survival time compared to historical study controls (17 months vs. nine months) with approximately 25% of patients living at least two years and approximately 20% at least three years.

In the Phase III study, TR002 will be administered in a single dose by catheter directly into the pleural cavity where the virus enters the cells lining the pleural cavity. “Inside the cells, the virus breaks down leaving the active gene to do its work. The internal gene/DNA machinery of the cells picks up the gene and translates its DNA sequence, resulting in the cells secreting high quantities of the interferon alfa-2b protein.” This approach turns “the patient's own pleural cavity cells into multiple interferon microfactories, enhancing the body's natural defenses against the cancer.”

Chemotherapy begins 14 days after the treatment and continues until disease progression.

In a Phase III study, the safety and effectiveness of treatments that have been shown to work in Phase II studies is compared against the safety and effectiveness of the current standard treatment. Patients are watched closely for side effects, and treatment is stopped if they are too damaging.

The National Institutes of Health (NIH) reports that the first gene therapy was approved in the European Union in 2012. This approval “boosted the investment in developing gene therapies.” Today, “regulators are creating a specific path for rapid access of those new therapies, providing hope for manufacturers, healthcare professionals, and patients.”

With promising results so far and support by regulators, Dr. Daniel H. Sterman, Director of the Multidisciplinary Pulmonary Oncology Program at NYU Langone Health, said, "we will work hard to get this potentially groundbreaking clinical trial completed."

If you have been diagnosed with mesothelioma, a newer or experimental therapy such as TR002 could be helpful in treating the disease. Talk to your doctor about participating in a clinical trial today.

 

Sources

Hanna, Eve, Cécile Rémuzat, Pascal Auquier, and Mondher Toumi. “Gene therapies development: slow progress and promising prospect.” National Center for Biotechnology Information (NCBI), U.S. National Library of Medicine. National Institutes of Health (NIH), 03 Jan. 2017. Web. 26 May 2019.

“Trizell Ltd. announces Phase 3 pivotal study of interferon alfa-2b gene therapy in malignant pleural mesothelioma.” BioSpace. BioSpace.com, 20 Mar. 2019. Web. 26 May 2019.

“Trizell Ltd. announces Phase 3 pivotal study of interferon alfa-2b gene therapy in malignant pleural mesothelioma.” PR Newswire. PR Newswire Association LLC, 20 Mar. 2019. Web. 26 May 2019.

“What Are the Phases of Clinical Trials?” Cancer.org. American Cancer Society, Inc., 2019. Web. 26 May 2019.