Chimerix Announces BK Virus Data In Late-Breaking Poster Session At The 24th International Congress Of The Transplantation Society
RESEARCH TRIANGLE PARK, N.C., July 9, 2012 /PRNewswire/ -- Chimerix, Inc., a biotechnology company developing orally-available antiviral therapeutics, today announced a late-breaking poster presentation at the 24th International Congress of the Transplantation Society being held July 15-19th, 2012 at the International Congress Centre Berlin in Berlin, Germany. The poster presentation, entitled "CMX001, a Novel Broad Spectrum Antiviral, May Mitigate Signs of BK Virus (BKV) Associated Bladder and Kidney End-Organ Damage," is part of the Late Breaking Abstracts session on Monday, July 16th from 12:15-13:30 pm in the Stockholm room.
Herve Mommeja-Marin, MD, Vice President of Clinical Research at Chimerix, will present the data from Study 201, Chimerix's Phase 2 study evaluating CMX001 for the prevention of cytomegalovirus (CMV) disease in hematopoietic stem cells transplant (HSCT) recipients. Phase 2 results presented elsewhere have shown that CMX001, at various doses, was active and well-tolerated in the prevention of CMV infection or disease. This new retrospective analysis focuses on BK virus and shows that CMX001 may prevent end-organ damage in subjects who had BKV infection in the urine upon initiation of therapy.
Chimerix is developing novel antiviral therapeutics with the potential to improve quality of life for patients in multiple settings, including transplant, oncology, acute care and global health. The company's proprietary lipid technology platform has given rise to Chimerix's two clinical stage compounds, CMX001 and CMX157, which have demonstrated the potential for enhanced activity, bioavailability and safety compared to currently approved drugs.
Chimerix's lead candidate, CMX001, is a novel, broad spectrum nucleoside analog that is anabolized intracellularly and inhibits double-stranded DNA (dsDNA) viruses including CMV, adenovirus (AdV), BKV, and herpes simplex virus. CMX001 has completed Phase 2 clinical development for the prophylaxis of CMV and is in Phase 2 development for the preemption and treatment of AdV infection in HSCT recipients. Antiviral activity from completed and ongoing studies, coupled with the lack of myelotoxicity and nephrotoxicity that are associated with currently available therapies, indicate that CMX001 has the potential to improve outcomes for stem cell and solid organ transplant recipients.
Chimerix has completed an End of Phase 2 meeting with the FDA for CMX001 and is preparing to initiate Phase 3 clinical development of CMX001 for the prophylaxis of CMV in HSCT recipients. To date, more than 750 patients have been dosed with CMX001 in controlled clinical trials and open-label treatment protocols. Under a contract from the Biomedical Advanced Research and Development Authority (BARDA), CMX001 is also being developed as a medical countermeasure to protect against a bioterror threat in the event of a smallpox release.
Chimerix is also developing CMX157, a novel nucleoside analog that delivers high intracellular levels of the active antiviral agent, tenofovir diphosphate. CMX157 has completed a Phase 1 clinical trial in healthy volunteers, demonstrating a favorable safety, tolerability and drug distribution profile. High intracellular concentrations of the active antiviral and a long-lasting intracellular half-life may allow for infrequent dosing and therefore increased dosing convenience. In addition, CMX157 exhibited highly potent in vitro activity against HIV, including HIV resistant to current therapies, and against HBV.
Led by an experienced antiviral drug development team, Chimerix is also leveraging its lipid technology and novel chemical library to pursue new treatments for other areas of high unmet medical need. For additional information on Chimerix, please visit http://www.chimerix.com.
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