Schering-Plough posts promising HIV data, starts new trial

Schering-Plough reported that results from the ongoing phase II clinical trial showed that vicriviroc, the company’s investigational CCR5 receptor antagonist, demonstrated potent and sustained viral suppression after 24 weeks of therapy in 118 treatment-experienced HIV patients, when administered in once-daily doses in combination with an optimized ritonavir-boosted protease inhibitor (PI)-containing antiretroviral regimen.

In the study, viral load decrease was significantly greater for patients in each vicriviroc group compared to the control group at day 14 and at week 24. Although there was no statistical difference in the viral load reductions between the three vicriviroc arms, a higher rate of virologic failure and emergence of X4 virus was observed at the lowest dose of 5mg.

This is the first trial with a CCR5 receptor antagonist for HIV to report 24-week treatment results.

Based on the findings from this study, as well as extensive pharmacokinetic and pharmacodynamic data, Schering-Plough Research Institute has also initiated a new phase II clinical trial of higher doses of vicriviroc in treatment-experienced HIV patients, with the goal of achieving incremental improvement in viral suppression.

This trial, which is called VICTOR-E1, will evaluate the safety and efficacy of vicriviroc (20mg and 30mg once daily) compared to placebo in combination with an optimized ritonavir-boosted, PI-containing antiretroviral regimen. The primary objective of the study is to evaluate the antiviral activity of vicriviroc as measured by the decline of viral load (log10 copies/mL) from baseline at 12 and 24 weeks.

A total of 120 patients who are currently failing an antiretroviral treatment regimen will be enrolled in the 48-week trial, which will be conducted at sites throughout Europe and North and South America.

In other announcements, Schering-Plough said that it has received clarification of its rights for Golimumab, a fully-human monoclonal antibody being co-developed by Schering-Plough and Centocor as a treatment for certain immune-mediated inflammatory diseases. Schering-Plough confirmed that its rights to market golimumab will extend to 15 years after the first commercial sale in its territories (worldwide, excluding the US, Japan and certain other Asian markets). The company hopes to launch golimumab in 2009 or 2010.