Chimerix, Inc., a biotechnology company developing novel antiviral therapeutics, today announced positive results from CMX001 Study 201, a Phase 2 study evaluating CMX001 for the prevention of cytomegalovirus (CMV) disease in hematopoietic stem cell transplant (HCT) recipients. CMX001 is a broad spectrum Lipid-Antiviral-Conjugate completing Phase 2 clinical development for the prevention of CMV in HCT recipients. In CMX001 Study 201, a double-blind, placebo-controlled trial which enrolled 230 HCT recipients, CMX001 had a statistically significant benefit versus placebo in preventing CMV viremia and/or CMV disease 13 weeks post-transplant.
Francisco Marty, MD, Assistant Professor of Medicine at Dana-Farber Cancer Institute and Brigham and Women's Hospital's Division of Infectious Disease, and a lead investigator in Chimerix's CMX001 Phase 2 CMV study, presented the data during the "Best Abstracts Plenary Session" at the 2012 BMT Tandem Meetings on February 3, 2012 in San Diego, California. "This study provides positive data supporting the antiviral activity of CMX001 at different dose levels, and a better understanding of CMX001's safety and tolerability as a prophylactic agent against CMV infection, a major cause of morbidity and mortality in bone marrow transplant recipients," said Dr. Marty. "There is a substantial unmet medical need for safer and effective therapies against CMV. If approved, many patients have the potential to benefit from the future availability of CMX001."
"These results exceeded our high expectations, and we are thrilled to share such positive CMX001 data with the transplant community," said Wendy P. Painter, MD, MPH, Chimerix's Chief Medical Officer. "We look forward to initiating the Phase 3 CMV program later this year. This study reinforces our belief that CMX001's broad spectrum application against multiple viral infections, its safety profile and convenient oral dosing will enable it to become a new standard of care for transplant recipients."