Chimerix Announces Presentation of Final Data from CMX001 Ph 2 Trial in Prophylaxis of CMV in Hematopoietic Stem Cell Transplant Patients
Chimerix Announces Presentation of Final Data from CMX001 Ph 2 Trial in Prophylaxis of CMV in Hematopoietic Stem Cell Transplant Patients
Chimerix Announces Presentation of Final Data from CMX001 Ph 2 Trial in Prophylaxis of CMV in Hematopoietic Stem Cell Transplant Patients
RESEARCH TRIANGLE PARK, NC, January 25, 2012 – Chimerix, Inc., a biotechnology company developing novel antiviral therapeutics, today announced that final data from CMX001 Study 201, a Phase 2 study evaluating CMX001 for the prevention of cytomegalovirus (CMV), has been accepted for oral presentation at the BMT Tandem Meetings on February 1‐5, 2012 in San Diego, California. CMX001 is a broad spectrum, Lipid‐Antiviral‐Conjugate completing Phase 2 clinical development for the prevention of CMV in hematopoietic cell transplant (HCT) recipients. In total, three abstracts related to CMX001
have been accepted for presentation at the 2012 BMT Tandem Meetings, the combined annual meetings of the Center for International Blood and Marrow Transplant Research (CIBMTR) and the American Society of Blood and Marrow Transplantation (ASBMT).
Francisco Marty, MD, Assistant Professor of Medicine at Brigham and Women's Hospital's Division of Infectious Disease and a lead investigator in Chimerix's CMX001 Phase 2 CMV study, will present the data during the "Best Abstracts Plenary Session" at 4:45 pm on Friday, February 3 in the Elizabeth Ballroom at the Manchester Grand Hyatt in San Diego. The presentation, entitled "CMX001 for Prevention and Control of CMV Infection in CMV‐Seropositive Allogeneic Stem Cell Transplant Recipients: A Phase 2, Randomized, Double‐Blind, Placebo‐Controlled, Dose Escalation Trial of Safety, Tolerability and Antiviral Activity," will highlight safety and efficacy results from the Phase 2 trial in 230 hematopoietic cell transplant recipients.
"Existing therapies for the prophylaxis and treatment of viral infections, including CMV, in the transplant recipient population are limited by their lack of broad spectrum efficacy and major side effects, notably nephrotoxicity and myelosuppression," said Wendy P. Painter, MD, MPH, Chimerix's Chief Medical
Officer. "The prevalence of the disease and the limitations of available therapies contribute to the significant unmet need of affected patients. CMX001 has the potential to fill this major unmet need and become the standard of care with its broad spectrum coverage of multiple viral infections, favorable
safety profile, and convenient oral dosing."
"We are extremely enthusiastic about the positive data emerging from Study 201 and our other clinical studies for CMX001," said Kenneth I. Moch, Chimerix President and Chief Executive Officer. "We look forward to initiating Phase 3 studies during 2012."
Additional CMX001 Presentations
Additional presentations at BMT Tandem will include data supporting use of CMX001 as periengraftment therapy for hematopoietic cell transplant recipients and in pediatric patients with adenovirus. Poster presentations begin on Wednesday, February 1.
‐ "CMX001 in the Peri‐Engraftment Period Does Not Impair Neutrophil Recovery in Pediatric Allogeneic Hematopoietic Stem Cell Recipients," will be presented by Michael S. Grimley, MD, Division of Bone Marrow Transplantation and Immune Deficiency, Cincinnati Children's Hospital Medical Center.
‐ "CMX001 as Therapy for Severe Adenovirus Infections in Immunocompromised Pediatric Patients: Single Experience in 5 Patients," which will also be presented by Dr. Grimley.
About CMX001
CMX001 is a Lipid‐Antiviral‐Conjugate that delivers high intracellular levels of the active antiviral agent cidofovir‐diphosphate and has broad spectrum activity against dsDNA viruses. CMX001 is completing Phase 2 clinical development for the prophylaxis of cytomegalovirus (CMV) and is in Phase 2 development for the preemption and treatment of adenovirus infection in hematopoietic cell transplant recipients. Efficacy results from completed and ongoing studies, coupled with the lack of myelotoxicity and nephrotoxicity seen in currently available therapies, indicate that CMX001 has the potential to improve outcomes for immunosuppressed patients.
CMX001 Study 201 is a randomized, placebo‐controlled Phase 2 study of CMX001 as prophylaxis for CMV in hematopoietic cell transplant recipients. 230 subjects were randomized (3:1) to receive CMX001 or placebo in five sequential, dose‐escalating cohorts. Subjects were dosed either once weekly (QW) or
twice weekly (BIW) for nine to 11 weeks until post‐transplant week 13, with a four‐to‐eight week followup period.
To date, more than 700 patients have been dosed with CMX001 in placebo‐controlled clinical trials and open‐label treatment protocols. Recently presented data from 183 patients who received CMX001 within a compassionate setting indicated that CMX001 showed no indication of the myelosuppression or nephrotoxicity associated with currently available antiviral therapies.
About Chimerix
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.
In addition to the company's development of its lead candidate, CMX001, for transplant recipients, 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, or a household contact of a contraindicated individual, and thus not candidates to receive a smallpox vaccine (for additional information, please see http://www.bt.cdc.gov/agent/smallpox/vaccination/contraindications‐clinic.asp). 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.