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 CMX001 will be able to make a significant difference."
"We believe CMX001's rapidly evolving antiviral and safety profile provides strong support for this candidate's broad-spectrum, preemptive usage, which includes the often-overlooked pediatric population," said Kenneth I. Moch, Chimerix President and CEO. "To date, CMX001 has been administered to more than 550 subjects and has demonstrated activity against a broad spectrum of dsDNA viruses. It has been well tolerated and has not shown toxicity in the kidneys or on bone marrow function."