Antisense Therapeutics approved to restart phase 2a trial for multiple sclerosis treatment

By Lisa Kerner

Erie, Pa., Jan. 18 - Antisense Therapeutics Ltd. received approval from the Ethics Committee of the University of Essen in Germany to restart the phase 2a trial of its antisense compound, ATL1102, for patients with relapsing-remitting multiple sclerosis (MS).

Multiple sclerosis is a life-long chronic disease of the central nervous system, believed to affect as many as 2.5 million people worldwide, according to a company news release.

ATL1102 is a second-generation antisense inhibitor of CD49d, an immune system protein known as VLA-4 (Very Late Antigen-4). It is currently in development as a treatment for MS.

The University of Essen is the primary trial site for the phase 2a clinical trial. Patient enrollment and dosing are expected to begin in February or March, said the release. The treatment and patient monitoring stages of the trial are expected to conclude by the end of 2006.

This multi-center, randomized, double-blinded, placebo-controlled phase 2a clinical trial is designed to assess the activity and safety of ATL1102 in 80 MS patients. The drug will be delivered by subcutaneous injection on a twice-a-week dosing schedule at a dose of 400 mg per week.

MRI's will be conducted at monthly intervals over the eight-week dosing period and at monthly intervals during the eight-week period following completion of dosing.

"We are pleased to receive approval from the University of Essen to restart the phase 2a trial and advance the development of ATL1102," Mark Diamond, Antisense chief executive officer, said in the release. "This follows the unanimous recommendation we received to continue the development of the compound as a treatment for patients with MS from the independent Medical Advisory Board that we convened last March to evaluate the most appropriate development path for the drug."

Antisense Therapeutics, based in Melbourne, Australia, is a biopharmaceutical drug discovery and development company.

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