RESEARCH TRIANGLE PARK, N.C., Sept. 21, 2012 /PRNewswire/ -- Chimerix, Inc., a biotechnology company developing orally-available antiviral therapeutics, today announced data highlighting the significant morbidity and resource utilization associated with the current standard of care for the management of cytomegalovirus (CMV) infection in hematopoietic stem cell transplant (HSCT) recipients. This analysis, entitled "Preemptive Therapy (PrT) for Cytomegalovirus (CMV) Post-hematopoietic Cell Transplantation (HCT) is Associated with Significant Morbidity and Resource Utilization," was presented at the 52nd Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC, September 9-12, San Francisco).
Morbidity and Resource Utilization Associated with Preemptive Therapy
Preemptive therapy is the initiation of antiviral therapy in the presence of viral infection. Chimerix's presentation highlighted adverse effects (AEs) experienced by patients who received preemptive therapy and were treated with currently available antiviral agents, including valganciclovir, ganciclovir, foscarnet and cidofovir.
A retrospective analysis of data from 71 patients who received preemptive treatment of CMV infection showed that the majority experienced at least one significant AE. These AEs included:
- Decreases in neutrophil counts, with some patients requiring granulocyte colony-stimulating factor, or G-CSF, to support neutrophil recovery;
- Other cytopenias, with some patients requiring transfusions;
- Renal impairment;
- Bacterial and fungal infections (including one patient death from sepsis);
- Seizures; and
- Fluid and electrolyte imbalances.
Of these patients, 18% had life-threatening AEs, including bacterial infections, cytopenias, and hemorrhages, and 23% had an AE that required hospitalization. While the currently available antiviral agents are associated with significant adverse events, including cytopenias, nephrotoxicity, electrolyte imbalances, and others, it cannot be determined from this retrospective analysis the degree to which a specific antiviral may have contributed to the occurrence or severity of any particular AE.
Unmet Medical and Economic Needs
It is widely accepted that viral infections, including CMV, adenovirus (AdV) and BK virus (BKV) infections, cause significant morbidity and mortality in HSCT recipients. These data shed light on the unmet medical needs associated with the current standard of care, preemptive therapy, and on the limitations of currently available antiviral agents.
In addition to the impact on morbidity and mortality, preemptive therapy dramatically increases the already significant costs associated with transplantation. The need for intervention and management of AEs, including hospitalization and the employment of expensive antivirals, antibiotics, antifungals and colony stimulating factors, place additional strains on an already over-burdened health care system.
Data from CMX001 Study 201
The data was presented by Herve Mommeja-Marin, M.D., Vice President of Clinical Research at Chimerix. According to Dr. Mommeja-Marin,
"There is a clear and unmet medical need for new antiviral compounds with improved safety, efficacy, and health economic profiles. An ideal antiviral will be sufficiently safe and effective to allow for the prophylactic administration of the drug to all at-risk patients, preventing infection from occurring and avoiding the morbidity, mortality, and costs associated with preemptive therapy."
In an effort to meet these significant medical and economic needs, Chimerix is developing CMX001, a novel broad-spectrum antiviral with activity against double-stranded DNA (dsDNA) viruses. These viruses negatively impact both stem cell and organ transplant recipients. CMX001 has demonstrated clinical activity in the prevention of CMV infection and preemption of AdV infection post-HSCT.
The data presented were derived from CMX001 Study 201*, Chimerix's Phase 2 study evaluating CMX001 for the prevention of CMV disease in HSCT recipients. The subset of patients described above received placebo or an inactive, low dose of CMX001.
Chimerix is planning to explore further the potential benefit of CMX001 in efficacy and safety, and reducing the burden of care. Chimerix is initiating a Phase 3 clinical trial of CMX001 for the prevention of CMV infection in adult CMV seropositive HSCT recipients, in which all subjects will be followed through 24 weeks post-transplant.
About Chimerix and CMX001
Chimerix is developing novel oral antiviral therapeutics with the potential to improve outcomes for patients in multiple therapeutic areas, including transplant, oncology, acute care and global health. The company's proprietary lipid technology has given rise to two clinical-stage lipid acyclic nucleoside phosphonates, CMX001 and CMX157, which have demonstrated the potential for enhanced activity and safety compared with currently approved drugs.
CMX001 is a novel, broad-spectrum, oral antiviral that inhibits dsDNA viruses, including CMV, AdV, BK virus and herpes simplex virus. CMX001 has completed Phase 2 clinical development for the prophylaxis of CMV in HSCT recipients and is in Phase 2 development for the preemption and treatment of AdV infection. To date, more than 800 patients have been dosed with CMX001 in controlled clinical trials and open-label treatment protocols. Chimerix has completed an End of Phase 2 meeting with the FDA and is preparing to initiate Phase 3 clinical development of CMX001 for the prophylaxis of CMV in HSCT recipients in early 2013.
In addition to its commercial use, CMX001 is being developed under a contract from the Biomedical Advanced Research and Development Authority (BARDA) as a medical countermeasure to protect against a bioterror threat in the event of a smallpox release. CMX001 has the potential to provide an important therapeutic option for the estimated 80 million immunocompromised people in the U.S. who are not candidates to receive a smallpox vaccine.
In July 2012, Chimerix granted an exclusive worldwide license to Merck for the development and commercialization of CMX157 for the treatment of HIV infection, further validating the company's propriety lipid technology.
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.
*CMX001 Study 201, NCT00942305
SOURCE Chimerix, Inc.