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Data Demonstrating the Safety and Efficacy of Chimerix's Antiviral CMX001 Presented at BMT Tandem Meetings
Date:2/19/2013

up receiving a CMX001 dose of 100 mg twice weekly reached statistical significance (p<0.05).  The lack of renal toxicity as well as the potential activity of CMX001 against BK virus are significant findings from this report.  CMX001 will be evaluated in the Phase 3 study, SUPPRESS, for prevention of CMV.  SUPPRESS will also explore the potential for activity against BK virus in HSCT.  

Monitoring Changes in Serum Albumin Concentrations as an Early and Objective Indicator of Potential CMX001-associated Gastrointestinal Adverse Drug Effects

In Study 201, diarrhea was found to be the dose-limiting side effect associated with CMX001.  As GI adverse events are common in this patient population, differentiating potential drug-related diarrhea from other etiologies is important to limit the impact of GI-related adverse events on optimal dosing duration in this population.  Decreases in serum albumin in association with worsening diarrhea can be used as a clinical and objective tool to discriminate drug-related diarrhea from diarrhea of other etiologies, prompting interruption of study drug in order to avoid progression to higher severity events.  Monitoring serum albumin levels has been incorporated into the overall Safety Monitoring and Management Plan for CMX001 and will be incorporated in the Phase 3 study, SUPPRESS.

BK virus-associated nephropathy (BKVN), an under-recognized cause of renal dysfunction in severely immunosuppressed hematopoietic stem cell transplant (HSCT) patients: Report of 5 cases of BKVN and the potential role of CMX001 for treatment

BK virus-associated nephropathy, BKVN, is observed in patients with renal transplants and is related to kidney graft loss.  In HSCT recipients, hemorrhagic cystitis (HC) is the most common BK virus manifestation.  A recent retrospective analysis at Memorial Sloan-Kettering Cancer Center revealed five cases of HSCT recipients with B
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SOURCE Chimerix, Inc.
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