Chimerix's CMX001 Shows Potential for Strong Antiviral Activity in Critically-Ill Immunocompromised Transplant Patients With Adenovirus Infection
Outcome Data for Patients Treated with CMX001 Under Emergency-IND Protocol Presented at the IDSA Annual Meeting
VANCOUVER, British Columbia and RESEARCH TRIANGLE PARK, N.C., Oct. 22 /PRNewswire/ -- Chimerix, Inc., a pharmaceutical company developing orally-available antiviral therapeutics, will present promising clinical data for CMX001 in a late-breaker poster session at the Infectious Diseases Society of America (IDSA) 48th Annual Meeting. Data from immunocompromised patients infected with adenovirus and treated with oral CMX001 demonstrated a significant drop in viral load compared to individual patient baseline, including several complete responses.
"Adenovirus infections among immunocompromised patients can be potentially fatal, with no approved treatments available. We are very pleased by the strong antiviral activity of CMX001 observed in these critically ill transplant patients, who had no other viable therapeutic options," said Wendy P. Painter, M.D., Chief Medical Officer of Chimerix. "We believe CMX001 has important potential for the prophylaxis and treatment of double-stranded DNA viruses. Based on the promising data seen in case studies from investigator EINDs, we plan to initiate a controlled Phase 2 study in patients with adenovirus infections early next year, in addition to our ongoing controlled studies of CMX001 for the prevention or control of cytomegalovirus infection."
CMX001 is a broad-spectrum antiviral agent with demonstrated activity against multiple double-stranded DNA viruses, initially being developed by Chimerix for the treatment of viral infections in immunocompromised transplant patients. Thirteen patients with a median age of 12 years (age range of 0.92-66 years) received at least four weeks of treatment with CMX001 for adenovirus disease under investigator-held Emergency Investigational New Drug applications (EINDs). The majority of patients had undergone stem cell transplant procedures and ten had graft-versus-host-disease (GvHD). Patients were diagnosed with adenovirus infection at a median of 68 days post-transplant. All patients initially received treatment with cidofovir for a median treatment of 21 days and were switched to CMX001 due to refractory adenovirus infection or renal toxicity. Patients were treated with oral CMX001 for a median of 68 days. Virologic response was measured at the end of treatment and defined as a greater than 2 log10 reduction in viral load. Of nine patients evaluable at week eight, viral load was lower compared to individual patient baseline with a median difference of 2.98 log10. Importantly, no drug-related serious adverse events were reported.
These data will be presented by Diana Florescu, M.D., Infectious Disease Division, Nebraska Medical Center, at the 48th Annual IDSA Annual Meeting during the late-breaking abstracts poster session on October 23, 2010 in a presentation titled "Experience with CMX001, A Novel Antiviral Drug, for Adenovirus Infections In Immunocompromised Patients" (Abstract # LB-44).
To date, Chimerix has provided CMX001 for more than 100 patients under investigator-held EINDs or foreign equivalent at over 45 leading medical centers in the US, Canada and Europe for the treatment of a wide range of life-threatening infections caused by double-stranded DNA viruses, including cytomegalovirus, adenovirus, BK virus, Epstein Barr virus, Herpes Simplex Virus and JC virus, for which there are either no FDA-approved treatments or where patients have failed the available treatment.
CMX001 combines Chimerix's PIM (Phospholipid Intramembrane Microfluidization) Conjugate Technology with cidofovir, an approved antiviral agent requiring intravenous administration, with the aim of creating a well-tolerated oral antiviral agent with potent broad-spectrum activity. CMX001 is initially being developed for both commercial and medical preparedness uses. A Phase 2 clinical trial is underway to assess the safety, tolerability and ability of CMX001 to prevent or control cytomegalovirus (CMV) infection in stem cell transplant recipients. In addition, Chimerix is completing a Phase 1 clinical trial of CMX001 in renal and stem cell transplant recipients with BK viruria, which like CMV can cause serious complications in immunocompromised patients. In clinical testing to date, CMX001 has shown oral bioavailability in humans and has demonstrated a positive safety profile.
Chimerix is developing novel antiviral therapeutics with the potential to transform patient care in multiple settings, including transplant, oncology, acute care and global health. The company's lead candidate, CMX001, is in Phase 1 and Phase 2 clinical studies in immunocompromised transplant and cancer patients for the treatment of life-threatening viruses, such as BK virus, cytomegalovirus and adenovirus. CMX001 is also being developed as a biodefense countermeasure in the event of a smallpox release. Chimerix has advanced a second antiviral compound, CMX157, into Phase 1 clinical studies as a potent nucleoside analogue against multi-drug resistant HIV infections. Led by a world-class antiviral drug development team, Chimerix is also leveraging the company's extensive chemical library to pursue new treatments for hepatitis C virus, malaria and other global public health needs.
Privately-held, Chimerix has received financing from Sanderling Ventures, Canaan Partners, Alta Partners, Asset Management Company and Frazier Healthcare Ventures, as well as significant funding from the National Institute of Allergy and Infectious Diseases. For additional information on Chimerix, please visit http://www.chimerix.com.
SOURCE Chimerix, Inc.
CONTACT: Kenneth I.
Moch, President and Chief Executive Officer of Chimerix, Inc.,
+1-919-313-2961; or Susan M. Pietropaolo or Michelle Corral, both
of BCC Partners, +1-201-923-2049 or +1-415-794-8662, for Chimerix,
Web Site: http://www.chimerix.com/
Posted: October 2010