Interim trial data on Genzyme's Campath show promise

Two-year interim results from Phase II trial comparing Genzyme Corporation's Campath (alemtuzumab) with Rebif (interferon beta-1a) for the treatment of multiple sclerosis (MS) have shown the drug is effective in preventing relapse and reducing MS progression.

The results derive from a pre-specified analysis conducted after two years of treatment for 334 pa-tients in the planned three-year trial.

Dosing of alemtuzumab in this study was suspended in September 2005 after three patients developed immune thrombocytopenic purpura (ITP), a treatable condition in which patients experience a low platelet count as a result of an immune response directed against the platelets.

The trial remains on clinical hold in the US, and Genzyme is working with clinical investigators and regulatory agencies to complete the study and ensure that the risk of ITP is well understood and managed.

Analysis of the first co-primary endpoint showed that patients taking alemtuzumab at high and low doses experienced at least a 75% reduction in the risk for relapse after at least two years of follow up when compared to patients treated with interferon beta-1a. This difference was statistically significant in favour of the alemtuzumab patients at both high and low doses.

Analysis of the other co-primary endpoint showed that patients taking alemtuzumab 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 interferon beta-1a.

Richard Moscicki, chief medical officer for Genzyme said: "We will work with regulatory agencies in the US and Europe, as well as our clinical investigators, to successfully complete this important trial and to prepare for the initiation of a Phase III trial in the first half of 2007."

The company has requested a meeting with the US Food and Drug Administration (FDA) to address the next steps in the development of alemtuzumab. It has already received scientific advice from the European Medicines Agency for a Phase III study.

Campath (alemtuzumab) is the first and only monoclonal antibody to be approved by the FDA, and is used for the treatment of patients with B-cell chronic lymphocytic leukemia. Genzyme is developing the drug in oncology, multiple sclerosis and other indications. Schering holds exclusive worldwide marketing and distribution rights.