Genzyme’s Interim Campath Results Show Efficacy

Genzyme Corp.’s interim results from a Phase II trial comparing Campath with Rebif for the treatment of multiple sclerosis show efficacy. The results are from a pre-specified analysis conducted after two years of treatment for 334 patients in the three-year trial.

As previously disclosed, dosing of Campath was suspended in September 2005 after three patients developed immune thrombocytopenic purpura (ITP), a condition causing a low platelet count as a result of an immune response directed against the platelets. At that time, most patients had received two cycles of therapy with Campath. Treatment with Rebif in the control arm has continued. The trial remains on clinical hold in the U.S., and the company is working with investigators and regulatory agencies to finish the study and ensure that the ITP risk is managed.

Analysis of the first co-primary endpoint showed that patients taking Campath at high and low doses experienced at least a 75% reduction in the risk for relapse after two years of follow up when compared to patients treated with Rebif. Analysis of the other co-primary endpoint showed that patients taking Campath at high and low doses experienced at least a 65% reduction in the risk for progression of clinically significant disability when compared to patients treated with Rebif. Results of additional secondary and tertiary efficacy endpoints, including MRI data, functional assessments, and quality of life measures, support these findings.

Genzyme has requested a meeting with the FDA to present these data and to address the next steps in the development of Campath. The company is moving forward with a Phase III study at the advice from the European Medicines Agency.