BERLIN -- On the occasion of the United European Gastroenterology Week (UEGW) in Copenhagen, Denmark, Schering AG, Germany, announced plans to initiate an additional phase III trial to evaluate sargramostim as a potential new treatment option for Crohn's disease.
The trial is being initiated as a result of a patient recruitment delay faced by NOVEL 3, one of two ongoing Phase III studies of sargramostim in Crohn's disease, and aims to achieve finalization of the phase III program as soon as possible.
Patient enrollment for NOVEL 4, the other pivotal phase III clinical trial of sargramostim in Crohn's disease, recently completed enrollment of more than 240 patients ahead of schedule. Data from NOVEL 4 are expected to be available in 2006.
These trials are part of N.O.V.E.L.™ (New Opportunities to Verify Evolving Logic in Crohn's disease), a comprehensive, worldwide clinical trials program supported by Schering AG for the ongoing development of sargramostim as a potential new treatment for Crohn's disease.
"Sargramostim provides a unique mechanism of action in Crohn's disease. We are strongly committed to continuing the phase III program with this compound," said Marc Rubin, MD, member of the executive board of Schering AG, responsible for development. "We look forward to initiating this additional phase III trial, which will broaden the patient population and generate additional safety and efficacy data in support of making sargramostim available to Crohn's patients worldwide."
Schering currently anticipates to submit sargramostim in the indication of Crohn's disease by the end of 2007, beginning of 2008.
About Schering
Schering AG is a research-based pharmaceutical company. Its activities are focused on four business areas: gynecology and andrology, oncology, diagnostic imaging as well as specialized therapeutics for disabling diseases.
Source: Schering AG