DURHAM, N.C., Nov. 11, 2011 /PRNewswire/ -- Chimerix, Inc., a biotechnology company developing orally-available antiviral therapeutics, today announced a late-breaking poster presentation at the American Society of Nephrology's (ASN) Kidney Week 2011 Annual Meeting being held November 8-13, 2011 in Philadelphia, PA.
V. Ram Peddi, MD, Transplant Nephrologist and Director of Kidney Transplant Research at California Pacific Medical Center, will present data from Chimerix's Phase 1/2 trial evaluating CMX001 in transplant patients with BK virus (BKV) infection. The poster presentation, entitled "CMX001 Was Well-Tolerated and Without Nephrotoxicity in Renal Transplant and Hematopoietic Stem Cell Transplant Recipients with BK Virus Infection in a Prospective, Randomized, Double-Blind Study," is part of the "Late-Breaking Clinical Trials Poster" session and begins at 10:00 am on Saturday, November 12 at the Philadelphia Convention Center.
"In the Phase 1/2 trial, CMX001 was generally safe and well tolerated when administered to renal transplant (RT) and hematopoietic stem cell transplant (HSCT) recipients," stated Wendy Painter, MD, MPH, Chief Medical Officer of Chimerix, Inc. "Importantly, no signs of nephrotoxicity were seen following five weekly oral doses of 40 mg and the pharmacokinetics of CMX001 and cidofovir were similar between kidney transplant and bone marrow transplant recipients." These findings are consistent with results from other CMX001 clinical trials and based on Chimerix's experience with subjects treated under emergency INDs.
CMX001 is being tested in ongoing placebo-controlled clinical trials and in open-label treatment protocols for the prophylaxis, pre-emption and treatment of double-stranded DNA (dsDNA) viruses, including herpesviruses and adenoviruses, and as a potential biodefense countermeasure in the event of a smallpox release. Data from an ongoing, placebo-controlled Phase 2 clinical trial of CMX001 in the prophylaxis of cytomegalovirus (CMV, a herpesvirus) in HSCT patients are expected during the first quarter of 2012.
Chimerix is developing novel antiviral therapeutics with the potential to transform patient care in multiple settings, including transplant, oncology, acute care and global health. Utilizing proprietary lipid conjugate technology, the company's two clinical stage compounds have demonstrated the potential for enhanced activity, bioavailability and safety compared to currently approved drugs.
The company's lead candidate, CMX001, is a lipid-antiviral-conjugate that delivers high intracellular levels of the active antiviral agent cidofovir-diphosphate. Its broad spectrum activity against viruses without the myelotoxicity and nephrotoxicity of currently available therapies has the potential to improve outcomes for immunosuppressed patients. CMX001 is in Phase 2 clinical development for the prophylaxis of cytomegalovirus (CMV) and the preemption and treatment of adenovirus infection in hematopoietic cell transplant recipients. Data from an ongoing, placebo-controlled Phase 2 CMV prophylaxis trial is expected during the first quarter of 2012. In an emergency IND cohort of adenovirus-infected transplant recipients, CMX001 has demonstrated its ability to reduce viremia and improve survival. To date, more than 650 patients have been dosed with CMX001 in placebo-controlled clinical trials and open-label treatment protocols.
CMX001 is also being developed as a medical countermeasure in the event of a smallpox release, with the potential to provide an important therapeutic option for the 80 million people in the U.S. currently estimated to be immunocompromised and thus not candidates to receive a smallpox vaccine. Chimerix has received federal funding for the development of CMX001 as a medical countermeasure against smallpox from the National Institute of Allergy and Infectious Diseases under Grant No. U01-A1057233 and from the Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, under Contract No. HHSO100201100013C.
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. CMX157 is in development as a potent nucleoside analogue against HIV and HBV infections, and has the potential to directly address several limitations of current therapies. CMX157 has completed a Phase 1 clinical trial in healthy volunteers, providing pharmacokinetic data which support the compound's enhanced characteristics.
Led by an experienced antiviral drug development team, Chimerix is also leveraging its lipid conjugate technology and extensive chemical library to pursue new treatments for hepatitis C virus, influenza, and other areas of high unmet medical need. For additional information on Chimerix, please visit http://www.chimerix.com.
SOURCE Chimerix, Inc.