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Chimerix Commences Phase 2 Clinical Study of CMX001 for Prevention of Adenovirus Disease in Pediatric and Adult Hematopoietic Stem Cell Transplant Patients
Date:7/13/2011

Durham, N.C., July 13, 2011 /PRNewswire/ -- Chimerix, Inc., a biotechnology company developing orally-available antiviral therapeutics, today announced that patient dosing has begun in the AdV HALT Trial (A Randomized, Placebo-Controlled, Multi-site Phase 2 Study Evaluating the Safety and Efficacy of Preemptive Treatment with CMX001 for the Prevention of Adenovirus Disease Following Hematopoietic Stem Cell Transplantation [HSCT]).The company also announced that the U.S. Food and Drug Administration (FDA) has granted CMX001 Fast Track designation status for the development program for this indication.

The Phase 2 AdV HALT Trial is a randomized, placebo-controlled study intended to evaluate the safety and efficacy of preemptive treatment with CMX001 in order to prevent immunocompromised pediatric and adult patients with asymptomatic adenovirus infection from developing disease.  Adenoviruses area family of double-stranded DNA (dsDNA) viruses responsible for respiratory diseases, including pneumonia and bronchitis, as well as other infections including gastroenteritis and acute diarrheal diseases. In immunocompromised patients, including those who have undergone HSCT, adenovirus infections are recognized as a significant cause of morbidity and mortality.  Immunocompromised pediatric HSCT patients are particularly susceptible to serious and/or fatal adenovirus infections.

"Pediatric HSCT patients are at increased risk of life-threatening adenovirus infections–yet we have no approved treatment options," said Joanne Kurtzberg, MD, Director, Carolinas Cord Blood Bank Division Chief, Pediatric Blood and Marrow Transplantation, Duke University Medical Center, and a lead investigator of the study. "It is well known that this population is less tolerant of the toxicities associated with conventional antiviral drugs, especially the kidney toxicity associated with cidofovir, and we hope CM
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4. Chimerix Names Wendy Painter, M.D., M.P.H., as Chief Medical Officer
5. Chimerix Names George Painter, Ph.D., Chairman of the Board and Chief Scientific Officer; Appoints Kenneth I. Moch President and Chief Executive Officer
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10. Chimerix Presents Update on CMX001 Development to the World Health Organization Advisory Committee on Variola Virus Research
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