Chimerix, Inc., a pharmaceutical company developing orally-available antiviral therapeutics, today announced the publication of the first reported case in which adenovirus (AdV) infection was successfully eradicated following treatment with its broad-spectrum antiviral drug, CMX001. Oral CMX001 was administered under an Emergency Investigational New Drug Application (EIND) to a severely immunocompromised pediatric stem cell patient following the patient's failure to respond to prior treatment with intravenous cidofovir. Data from this case report were published in the February edition of the Journal of Clinical Virology.
"Cases such as this highlight the life-saving potential of CMX001 to successfully and safely resolve severe viral infections. Data generated from Chimerix's clinical studies and numerous EIND cases in which CMX001 has been used to combat the full spectrum of double-stranded DNA viruses have greatly informed our late-stage clinical development plans," said Wendy Painter, M.D., Chief Medical Officer of Chimerix. "We see a unique opportunity to develop this drug for the prevention and treatment of viral infections that are frequently fatal to transplant patients. In particular, the lack of viable treatment options in the pediatric patient population must be rapidly addressed and we are preparing to initiate a Phase 2 clinical study in pediatric and adult transplant patients with adenovirus infections."
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 release. 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 cytomegalovirus. Chimerix is initiating a Phase 2 clinical study in immunocompromised pediatric and adult hematopoietic stem cell transplant patients with AdV infections. An open label study is also underway for the treatment of any of 12 different dsDNA viral infections, including adenovirus, herpes viruses such as CMV, herpes simplex virus and Epstein Barr virus, polyoma viruses such as BK virus and JC virus, and pox viruses.
Emergency IND Case Study of Disseminated Adenovirus Infection
The study was carried out under an EIND granted by FDA in a severely immunocompromised twelve-year-old bone marrow transplant patient. The patient presented with diarrhea, AdV viremia, AdV enteritis and positive cultures for AdV in the lung. Despite a reduction in immunosuppressive medications, the patient's AdV viremia continued to increase. Her clinical condition worsened, with severe gastrointestinal (GI) bleeding, hepatitis and respiratory failure. Initial treatment with intravenous cidofovir did not control the infection.
Once CMX001 treatment was initiated, a prompt and continued reduction in plasma adenovirus load was noted. Within five weeks of initiating treatment with oral CMX001, the patient's viral load was reduced to undetectable levels, while renal and hepatic function improved. Within eight weeks, the patient was transferred out of intensive care, hemodialysis was discontinued, and the patient's GI bleeding and renal impairment were resolved. Following resolution of AdV viremia and clinical signs and symptoms of disease, the patient was maintained on CMX001, which was well tolerated and no drug-related serious adverse events were observed.
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