Chimerix Announces Late-Breaker Presentation at 51st Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) Annual Meeting CMX001 shows no nephrotoxicity or myelosuppression in 183 patients treated under emergency INDs
DURHAM, N.C., Sept. 16, 2011 /PRNewswire/ -- Chimerix, Inc., a biotechnology company developing orally-available antiviral therapeutics, announced today that investigators will present preliminary data for CMX001 in a late-breaker presentation at the 51st Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC, Chicago – September 17-20).
Genovefa Papanicolaou, M.D., Associate Member of Infectious Diseases Service at Memorial Sloan-Kettering Cancer Center and one of the lead investigators in Chimerix's ongoing Phase 2 cytomegalovirus (CMV) study, will give a presentation entitled, "CMX001 is not nephrotoxic or myelosuppressive in 183 patients with life threatening dsDNA infections including refractory Cytomegalovirus, Adenovirus, and BK Virus," on Sunday, September 18 at 8:30 am CDT. Immediately following Dr. Papanicolaou's presentation, Richard Whitley, M.D., Distinguished Professor at The University of Alabama at Birmingham, will present "New Antivirals for Herpes Viruses: What Can We Look Forward to and When?," which highlights CMX001. Both presentations are part of the "Herpes and Other Viruses" slide session that begins at 8:30 am CDT. In accordance with ICAAC embargo policy, these data remain under embargo until conclusion of the late-breaker session on Sunday, September 18 at 11:00 am CDT.
Data from Dr. Papanicolaou's presentation was generated as part of Chimerix's expanded access program, through which Chimerix has dosed over 300 subjects with CMX001 since March 2009, including 183 subjects under investigator-held Emergency Investigational New Drug applications (EINDs) or foreign equivalents at over 80 medical centers in the United States, Canada, Europe, and Israel. Through EINDs, CMX001 has been used for the treatment of a wide range of life-threatening infections caused by dsDNA viruses, including CMV, adenovirus (AdV), BK virus (BKV), Epstein Barr virus (EBV), herpes simplex virus (HSV), and JC virus (JCV), for which there are no FDA-approved treatments or where patients have failed available treatments. There is no evidence of otherwise unexplained nephrotoxicity or myelosuppression in these immunocompromised patients. These data support positive interim results seen in CMX001's ongoing Phase 2 placebo-controlled clinical trial evaluating the safety, tolerability and ability of CMX001 to prevent or control CMV infection in R+ hematopoietic cell transplant (HCT) recipients.
CMX001 is an oral Lipid-Antiviral-Conjugate (LAC) that delivers high intracellular levels of the active antiviral agent cidofovir-diphosphate. Its broad spectrum activity against double-stranded DNA (dsDNA) viruses without the myelotoxicity and nephrotoxicity of current agents has the potential to improve outcomes for immunosuppressed patients. In development for the treatment or prevention of life-threatening dsDNA viral diseases, more than 600 patients have been dosed with CMX001 in placebo-controlled clinical trials and open-label treatment protocols. More than 300 of these individuals have received CMX001 under Emergency Investigational New Drug Applications (EINDs) or as part of the CMX001-350 Open-Label Study to help treat life-threatening dsDNA viral diseases for which there were no other therapeutic options. CMX001 is also being developed as a biodefense countermeasure in the event of a smallpox release. The growing body of evidence of CMX001's antiviral activity against all five families of dsDNA viruses that cause disease in humans, including smallpox, has strengthened the compound's potential as a dual-use product prescribed as a traditional pharmaceutical and stockpiled as a biodefense countermeasure.
Clinical studies of CMX001 include an ongoing Phase 2 study for the prevention cytomegalovirus (CMV) in adult hematopoietic cell transplant patients (CMX001-201); a Phase 2 study for the treatment of adenovirus infection in pediatric and adult hematopoietic cell transplant patients (AdV HALT Trial/CMX001-202); and an Open-Label Study (CMX001-350) for the treatment of dsDNA viral infections.
Chimerix is developing novel antiviral therapeutics with the potential to transform patient care in multiple settings, including transplant, oncology, acute care and global health. Based on proprietary lipid conjugate technology, the company's two clinical stage compounds have demonstrated enhanced activity, bioavailability and safety compared to currently approved drugs. CMX001 is a lipid-antiviral-conjugate that delivers high intracellular levels of the active antiviral agent cidofovir-diphosphate. Its broad spectrum activity against double-stranded DNA (dsDNA) viruses without the myelotoxicity and nephrotoxicity of current agents has the potential to improve outcomes for immunosuppressed patients. Chimerix's second clinical-stage antiviral compound, CMX157 is a lipid-antiviral-conjugate that delivers high intracellular levels of the active antiviral agent tenofovir-diphosphate. It has the potential to directly address several limitations of current HIV and HBV therapies. 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, influenza, malaria and other global public health needs. For additional information on Chimerix, please visit http://www.chimerix.com.
SOURCE Chimerix, Inc.