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news.Antisense Therapeutics has received approval from the ethics committee of the University of Essen in Germany to restart the phase IIa trial of its antisense compound, ATL1102, for patients with relapsing-remitting multiple sclerosis.
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The University of Essen is the primary trial site for the phase IIa clinical trial which 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.
The goal of the trial is to obtain preliminary evidence of the drug’s effectiveness, which will be evaluated using magnetic resonance imaging (MRI). MRI scans 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.
The treatment and patient monitoring stages of the trial are expected to conclude by the end of 2006, assuming patient recruitment proceeds as scheduled. The University of Essen will be the primary site for the trial, with eight other trial centers in Germany to be initiated in the coming months.
“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,” said Mark Diamond, CEO.