Chimerix, Inc., a pharmaceutical company developing orally-available antiviral therapeutics, today announced that patient enrollment has begun in a multicenter, open-label clinical study of CMX001 (the CMX001-350 study) for the treatment of life-threatening or serious conditions caused by double-stranded DNA (dsDNA) viruses.
Under the expanded-access protocol developed in conjunction with the U.S. Food and Drug Administration (FDA), patients will receive treatment with CMX001 for any of 12 different dsDNA viral infections, including adenovirus (AdV), herpes viruses (cytomegalovirus (CMV), herpes simplex virus (HSV) and Epstein Barr virus), polyoma viruses (BK virus and JC virus), and pox viruses. The CMX001-350 study will enroll 200 patients at major medical centers primarily in the United States.
CMX001 is being developed by Chimerix for dual-use as a broad-spectrum antiviral for the treatment of life-threatening viral infections in immunocompromised patients and as a medical countermeasure in the event of a smallpox outbreak. Chimerix is currently conducting a Phase 2 dose-defining clinical study of CMX001 in immunocompromised hematopoietic stem cell transplant patients at risk of life-threatening infection with CMV, which has enrolled over 130 patients. Additionally, the Company is initiating a Phase 2 clinical study in immunocompromised pediatric and adult hematopoietic stem cell transplant patients with AdV infections.
"Data from this open-label clinical study will be a critical component of our strategy to develop CMX001 as a broad-spectrum antiviral agent," said Kenneth I. Moch, President and CEO of Chimerix. "We anticipate that the CMX001-350 study will provide important supportive data for our overall clinical development program."
"CMX001 is exhibiting a favorable tolerability profile and signs of potent antiviral activity across our clinical studies, including the more than 130 Emergency INDs requested by leading investigators," said Wendy Painter, M.D., M.P.H., Chief Medical Officer of Chimerix. "The demand for CMX001 to treat life-threatening infections continues to grow among the clinical community, and we are extremely proud to provide CMX001 under this open-label study."
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