Phase III Trials Of Natalizumab To Begin Soon.(Antegren monoclonal antibody)

2001 OCT 10 - (NewsRx.com & NewsRx.net) --

Antegren (natalizumab), a humanized monoclonal antibody, demonstrated promising results on multiple endpoints in a Phase II study in multiple sclerosis (MS), according to data presented September 15, 2001, at the annual meeting of the European Congress on Treatment and Research in Multiple Sclerosis (ECTRIMS).

Biogen, Inc. and Elan Corporation, plc are collaborating on the development, manufacture, and marketing of Antegren, one of the first in a new class of potential therapeutics discovered by Elan. Antegren, an alpha-4 integrin inhibitor was designed to prevent migration of inflammatory cells from blood vessels into tissues. This pathway was pioneered by both Elan and Biogen.

Elan conducted a Phase II, double-blind, placebo-controlled trial of 213 MS patients at 26 sites in the U.S., Canada, and the U.K. Patients received either of two Antegren doses (3 mg/kg or 6 mg/kg) or placebo by intravenous infusion every four weeks for six months. Participants in the trial had either relapsing-remitting MS or secondary progressive MS.

The primary analysis was based on MRI scans and showed that patients treated with Antegren for six months had fewer new gadolinium-enhancing lesions than patients treated with placebo. In the placebo group (n=71), the cumulative mean number of new enhancing lesions during the treatment period was 9.6, whereas the Antegren 3 mg/kg group (n=68) had a mean of 0.6 new lesions and the Antegren 6 mg/kg group (n=74) had accumulated 1.2 new lesions during the same period.

"The robust effects of Antegren in reducing MRI activity is promising and suggest that the agent's mechanism of action has potential as a new approach to treating MS. This will be investigated in further trials," said David Miller, MD, professor of neurology, Institute of Neurology, London, United Kingdom.

Secondary endpoints in the study included the change in the MSFC (MS Functional Composite) and in the EDSS (Expanded Disability Status Score) over the treatment phase. There were no changes seen (in these parameters) in either the placebo or treatment groups over the six months of treatment.