Genzyme has requested a meeting with FDA to "address the next steps" in developing its multiple sclerosis drug Campath (alemtuzumab) after reporting positive interim efficacy results Sept. 14.

The trial has been on clinical hold since September 2005, when dosing was halted after three patients developed severe idiopathic thrombocytopenia purpura, one fatally (¹ Also see "Genzyme’s Campath MS Safety Profile Expected From FDA By July; Phase III Set For Second Half" - Pink Sheet, 19 May, 2006.). Genzyme and partner Schering AG, however continued to collect safety and efficacy data from the study.

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 Serono's Rebif (interferon beta-1a), Genzyme reported.

On the other co-primary endpoint, risk of progression of clinically significant disability, patients at high and low doses experienced at least a 65% reduction compared to Rebif, the company said.

"These results continue to demonstrate that alemtuzumab has great potential to make a meaningful impact on the treatment of multiple sclerosis," said Genzyme Chief Medical Officer Richard Moscicki.

"We will work with regulatory agencies in the [U.S.] 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," Moscicki said.

Campath currently is approved for B-cell chronic lymphocytic leukemia.

- Shirley Haley (s.haley@elsevier.com)

Genzyme Reports Interim Data From Troubled Campath Study

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