UB collaborating with Roswell Park on international clinical trial for COVID-19

UB and Roswell Park Comprehensive Cancer Center have launched a collaborative clinical trial that will make a new investigational treatment option available to local patients diagnosed with COVID-19. The study, led by Igor Puzanov of Roswell Park, will allow eligible patients at four local medical facilities to participate in a large international study of the anti-inflammatory agent sarilumab.

“As a career-long investigator in viral diseases, I am excited by the advances possible for treating COVID-19 and HIV by applying new knowledge learned about the immune system by cancer researchers,” says Gene Morse, SUNY Distinguished Professor in the School of Pharmacy and Pharmaceutical Sciences and the Jacobs School of Medicine and Biomedical Sciences.

Morse is co-principal investigator with Puzanov, director of the early phase clinical trials program and chief of melanoma at Roswell Park. Morse will oversee protocol activities for the three additional sites invited to participate in this study: Erie County Medical Center, in collaboration with John Crane, professor of medicine in the Jacobs School, and Buffalo General Medical Center and Millard Fillmore Suburban Hospital, in collaboration with Jamie Nadler, also professor of medicine in the Jacobs School.

Morse is also director of UB’s Global Virus Network Center of Excellence.

Puzanov is overall principal investigator on the trial. He has done extensive work with a similar drug, tocilizumab.

“Some of the ways that COVID-19 affects the body are similar to how cancer and auto-immune conditions affect the body, so we can draw on what we know from those fields to address the pressing challenge of how best to treat the novel coronavirus,” he says. “We are applying the extensive expertise in immunotherapies and the immune response that we have here at Roswell Park and UB, hoping that we can improve outcomes for individual patients and dampen the pandemic’s impact on Buffalo and Western New York.”

“The ability to quickly launch this important clinical trial as a collaborative effort between Roswell Park and UB, and including Kaleida and ECMC, proves the direct, meaningful benefit that these partnerships bring to our entire community at such a critical time,” says Timothy F. Murphy, SUNY Distinguished Professor in the Jacobs School and director of UB’s Clinical and Translational Science Institute.

“This clinical trial, which came together in a matter of days, is a great example of how collaborative research moves farther and faster than work any one of our centers could achieve alone,” notes James Mohler, a urologist who is associate director and senior vice president, translational research, and chief, Inter-Institutional Academics, at Roswell Park. “We hope to announce soon clinical trials of other new or repurposed drugs to help patients suffering from COVID-19 in Western New York and elsewhere.”

The local trial will be part of a large international clinical trial sponsored by Regeneron and Sanofi, the companies that makes sarilumab. The drug, also known as Kevzara, is a monoclonal antibody that inhibits the interleukin-6 (IL-6) pathway by binding and blocking the IL-6 receptor. While it has been approved by the U.S. Food and Drug Administration as a treatment for rheumatoid arthritis, experts believe IL-6 inhibitors may help to prevent or control the overactive inflammatory response in the lungs of patients who are severely or critically ill with COVID-19 — conclusions based in part on preliminary data from a study in China using the similar agent, tocilizumab.

The study is expected to enroll quickly and may only be open to new patients for a brief period.

Additional collaborative studies for COVID-19 and other diseases are anticipated through this network of clinical researchers.