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ATL/TV1102 Trial Results Presented at World Congress on Treatment and Research in Multiple Sclerosis
Date:9/21/2008

nthly over 16 weeks. Primary efficacy variable: cumulative number of new active lesions (CNNAL; new gadolinium-enhancing T1 lesions (T1-Gd), new or enlarging T2 lesions) on MRIs taken at weeks 4, 8 and 12. Secondary efficacy variable: cumulative volume of T1-Gd lesions (CVT1L) on MRIs taken at weeks 4, 8 and 12.

Results: ITT population: 74 patients with a valid baseline MRI and at least one post-baseline MRI scan after first injection of study medication (n=39 placebo, n=35 ATL1102). ATL1102 showed a significant reduction, 54.4%, in CNNAL (6.2 placebo, 3.0 ATL1102; p=0.01). A reduction of 66.7% (p=0.002) was observed in the cumulative number (weeks 4,8,12) of new T1-Gd lesions with ATL1102. A reduction in CVT1L was also observed under ATL1102 but did not reach significance (589.4 mm3 placebo, 358.0 mm3 ATL1102; p=0.1068). Adverse events that were more frequent under ATL1102 included mild to moderate injection site reactions and a tendency for decreased platelet counts which were reversible after treatment interruption.

Conclusions: This proof-of-concept study of a drug designed to inhibit VLA-4 mRNA showed a significant reduction of the cumulative number of new active lesions in RR-MS patients following 8 weeks of treatment. These promising results warrant further investigation.

Background Information

ATL/TV1102 Phase IIa trial is a randomised, double-blind, placebo-controlled clinical trial of ATL/TV1102. Patients received either ATL/TV1102 or placebo injections over 8 weeks, and were monitored with monthly MRI (magnetic resonance imaging) brain scans during treatment, and for the 8 weeks following treatment. 77 patients were enrolled in the trial, which was conducted at multiple trial sites across six European countries.

Multiple sclerosis is a lifelong chronic disease of the central nervous system which is believed to affect as many as 2.5 million people worldwide. Global drug sales for MS are in excess of $US 6 billion and are
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SOURCE Isis Pharmaceuticals, Inc.; Antisense Therapeutics Ltd.
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