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Globeimmune Reports Promising Results From Phase II Hepatitis Trial

Posted on: Tuesday, 4 November 2008, 03:00 CST

Globeimmune, a biopharmaceutical company, has announced that a four-week Phase II clinical trial data showed that GI-5005, the company's hepatitis C virus targeted molecular immunogen, doubled viral clearance overall and in all major subgroups and doubled the rapid virologic response rate in naive patients with high viral load.

The study compared GI-5005 plus standard of care (SOC) - pegylated-interferon plus ribavirin - versus SOC alone in patients with chronic genotype 1 hepatitis C infection.

The GI-5005-02 clinical trial is a randomized, multi-center, Phase II study evaluating 140 patients, all with genotype 1 HCV infection. In the trial, 74% of the patients had never received prior treatment, and the remaining 26% experienced prior treatment failures.

According to the company, treatment-naive patients with high viral loads at baseline (>600,000 IU/ml) saw a 2.6-fold improvement in rapid virologic response (RVR), which is defined as undetectable hepatitis C virus (HCV) RNA levels (<25 IU/ml) by four weeks. RVR is highly predictive of whether a patient will achieve a sustained virologic response (SVR), or 'cure', which is defined as undetectable HCV RNA at six months post-treatment.

A significant improvement was also noted in the rate of viral reduction in the peripheral blood using viral kinetic analysis in all patients, with a two-fold improved slope (0.32 log10/month difference, p=0.02) for patients receiving GI-5005 in addition to SOC. Comparable magnitude of increased viral clearance in GI-5005 treated patients was noted in all patient subgroups including prior non-responders and patients with high viral load at baseline.

John mchutchison, principal investigator of the study, said: "These data represent early but important evidence that a patient's natural immune response can be harnessed to positively influence important virologic endpoints with the potential to impact the course of chronic HCV infection.

"The rational combination of novel immune approaches such as GI-5005 with IFN-based standard of care or with novel direct acting antiviral agents holds promise in terms of ultimately improving clinical outcomes, shortening the exposure to toxic therapies, or both."

Source: Datamonitor

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