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Chimerix Commences CMX001 Open-Label Clinical Study for the Treatment of Patients With Life-Threatening or Serious dsDNA Viral Infections
Date:1/7/2011

s, 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."

CMX001-350 Open-Label Study Design

The primary objective of the multicenter open-label study of CMX001 is to provide CMX001 to patients with immediately life-threatening or serious disease caused by any of 12 different viral infections resulting from dsDNA viruses. The open-label study is expected to enroll 200 infected adult and pediatric patients.  Critically-ill patients expected to enroll in this study in the highest numbers include immunocompromised patients suffering from a variety of dsDNA infections, particularly patients undergoing solid organ transplant or hematopoietic stem cell transplant.  However, the study is intended for any patient with a serious dsDNA viral disease for whom no satisfactory alternate therapy is available and who does not qualify for other CMX001 clinical studies.(1)

The study will evaluate the safety, tolerability and antiviral activity of CMX001.  Researchers will also evaluate the activity of CMX001 through changes in clinical signs and symptoms of infection.  Patients will receive CMX001 orally twice weekly for up to three months, and treatment may be extended for up to six months depending on the patient's clinical response.  Antiviral activity will be measured by changes in viral burden from baseline in an individual patient's condition and across all patients with a given dsDNA virus.  Drug pharmacokinetics and any potential signs of drug resistance will also be assessed.

The clinical design parameters of the CMX001-350 study were based in large part on Chimerix's experiences providing CMX001 to patients under investigator-held
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SOURCE Chimerix, Inc.
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