February 18, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
2015 will be a “pivotal year” for Chimerix and its investigational antiviral brincidofovir, the chief medical officer of the company told BioSpace Wednesday, as its team awaits the results of a Phase III trial testing the drug, which are expected in the second half of the year.
“Originally developed to treat smallpox, brincidofovir is also being studied to prevent or treat common viruses, such as cytomegalovirus (CMV) and adenovirus, that can be deadly in people with weakened immune systems, especially following a bone marrow [like hematopoietic cell transplant, HCT, or organ transplant,” W. Garrett Nichols, a medical doctor and chief medical officer of Chimerix, told BioSpace.
Chimerix’s Phase III SUPPRESS trial is measuring for the prevention of CMV infection in bone marrow transplant recipients. If it goes well, the company will likely see a significant boost from pleased shareholders, and the satisfaction of having the only approved therapy for the prevention of CMV in patients with compromised immune systems.
“CMV infections can result in life-threatening pneumonia, particularly in the first 100 days following transplant,” said Nichols.
He said he’s also excited about additional applications of the drug, particularly in the area of organ transplantation.
“We are also discussing with regulators plans for a CMV prevention trial in kidney transplant recipients. While there have been dramatic improvements in kidney transplants, less than half of transplanted kidneys are still functioning 10 years after transplant,” said Nichols. “Reducing injury to the kidneys from viral infection, and the drugs used to treat them, could make a huge difference in better managing one of our most scarce resources.”
Chimerix’s Phase III AdVise trial for the treatment of adenovirus infection is ongoing, another infection that can be fatal in people with weakened immune systems.
“With no approved treatments for adenovirus, short-term mortality rates are as high as 80 percent. We announced on Feb. 12 at the BMT Tandem Meetings preliminary data from the open-label trial showing a short-term mortality rate of less than 40 percent,” Nichols told BioSpace. “We’re encouraged by these data which support our earlier presentation at IDWeek and reinforce the potential for brincidofovir to improve upon historical survival rates for adenovirus infection and to potentially provide the first approved treatment for this life-threatening infection.”
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