Main Category: Transplants / Organ Donations
Also Included In: Infectious Diseases / Bacteria / Viruses;  Stem Cell Research
Article Date: 27 Sep 2013 – 1:00 PDT

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CMX001 to Prevent Cytomegalovirus Disease in Hematopoietic-Cell Transplantation

Financial support for the trial was provided by Chimerix.

In a paper in the Sept. 26 issue of the New England Journal of Medicine, the researchers report that patients who took the drug CMX001 shortly after transplant were far less likely to develop cytomegalovirus (CMV) infection than were patients who took a placebo. CMV disease is a common source of illness in transplant patients and can cause pneumonia, diarrhea and digestive tract ulcers, or other problems. Although some antiviral drugs, when administered at the earliest signs of CMV infection, often forestall CMV disease, they often cause kidney dysfunction or impair patients’ ability to make new blood cells.

The senior author of the study is Michael Boeckh, MD, of the Fred Hutchinson Cancer Research Center in Seattle. Co-authors are Drew Winston, MD, of the University of California, Los Angeles; Scott Rowley, MD, of Hackensack University Medical Center, New Jersey; Estil Vance, MD, of Baylor Charles A. Sammons Cancer Center, Dallas; Genovefa Papanicolaou, MD, of Memorial Sloan-Kettering Cancer Center; Kathleen Mullane, DO, of the University of Chicago Medical Center; and Thomas Brundage, MS, Alice Robertson, PhD, Susan Godkin, RPh, and Herve Mommeja-Marin, MD, of Chimerix, of Durham, N.C. N Engl J Med 2013; 369:1227-1236September 26, 2013DOI: 10.1056/NEJMoa1303688

The new, phase II clinical trial involved 230 hematopoietic (blood-making) stem cell transplant recipients at 27 treatment centers across the United States. They participants were randomly assigned to receive either oral CMX001 (at varying doses) or a placebo, which they began taking after the transplanted cells engrafted, or took root in the bone marrow – which usually occurs two to three weeks after the transplant procedure. They took the pills for 9-11 weeks.

Dana-Farber Cancer Institute

“With current agents, between 3 and 5 percent of allogeneic [donor] transplant patients develop CMV disease within six months of transplantation, and a small number of them may die of it,” says study lead author Francisco Marty, MD, of Dana-Farber and Brigham and Women’s. “There clearly is a need for better treatments with fewer adverse effects. This clinical trial examined whether the disease can be prevented, rather than waiting for blood tests to show that treatment is needed.”

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