Chimerix Presents Data Highlighting Burden Of Care Associated With Current Antiviral Therapies In Stem Cell …

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:

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.

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Chimerix Presents Data Highlighting Burden Of Care Associated With Current Antiviral Therapies In Stem Cell ...