RESEARCH TRIANGLE PARK, N.C., Jan. 7, 2011 /PRNewswire/ —
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 studie
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