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Chimerix's Antiviral CMX157 Demonstrates Positive Phase 1 Clinical Results With Favorable Pharmacokinetics, Safety and Tolerability
Date:12/13/2010

the treatment of HIV and other applications, including its potential to address XMRV associated with chronic fatigue syndrome," said Kenneth I. Moch, President and Chief Executive Officer of Chimerix.  "We believe CMX157 holds promise as a highly competitive anti-HIV agent, suitable for combination regimens, with a favorable pharmacokinetic and tolerability profile, and potential for once-weekly dosing.  Further, we have intriguing in vitro data showing our PIM Conjugate Technology may facilitate CMX157 access across the blood-brain barrier to address latent retrovirus in compartments that otherwise have proven to be inaccessible by conventional anti-HIV agents.  There's a significant need for new HIV therapies to help refractory and inadequately treated patients, and our next step is to evaluate CMX157 in HIV patients."

CMX157 Phase 1 Clinical Trial Results

CMX157 is a new chemical entity created by applying Chimerix's PIM (Phospholipid IntramembraneMicrofluidization) Conjugate Technology to chemically modify tenofovir, the molecule underlying the prodrug Viread®, an antiviral agent approved for the treatment of human immunodeficiency virus (HIV) and chronic hepatitis B. The CMX157 Phase 1 clinical study was a randomized, blinded, dose-escalation trial to evaluate safety, tolerability and pharmacokinetics.  Healthy volunteers received a single dose ranging from 25 mg to 400 mg of CMX157 or a standard dose of Viread for comparison of intracellular levels of the active antiviral, tenofovirdiphosphate (TFV-PP). CMX157 was well tolerated and there were no laboratory, vital sign, electrocardiogram changes or adverse event trends attributable to drug. In addition, plasma concentrations of CMX157 increased linearly with dose and target plasma levels were attained. The active antiviral, TFV-PP, was measurable in peripheral blood mononuclear cells (PBMC) from all patients after a single 400 mg dose of CMX
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