Antisense is finally restarting their phase II trial after getting caught in the tysabri whirlwind.
Commencement of dosing of patients in Phase IIa Multiple Sclerosis trial
June 21, 2006 - Press Release from Antisense Therapeutics - Antisense Therapeutics is pleased to report that dosing has commenced in the Phase IIa clinical trial of ATL1102 in patients with relapsing remitting multiple sclerosis (MS).
The study, a multi-centre, randomized, double-blinded, placebo-controlled clinical trial in approximately 80 patients with relapsing-remitting MS, is being conducted at 9 clinical trial sites across Germany. The trial will assess the activity and safety of the drug in MS patients.
Mark Diamond, Managing Director of Antisense Therapeutics commented “The Company has been focussed on moving ATL1102, our lead drug candidate, back into clinical development and it is exciting to report that the trial is now underway. There have been recent positive market developments that provide further validation for ATL1102. These include FDA approval for the re-introduction to the market of the high profile MS drug Tysabri® and also positive data from Phase II clinical trials of Isis Pharmaceuticals’ antisense drugs for cholesterol and diabetes.”
Following the Company’s recent capital raising, Antisense Therapeutics is fully funded to undertake this Phase IIa study of ATL1102 in MS patients.
About ATL1102 for MS
ATL1102 is a second generation antisense inhibitor of CD49d, a subunit of VLA-4 (Very Late Antigen-4), and is currently in Phase II clinical trials as a treatment for MS. In inflammation, white blood cells (leukocytes) move out of the bloodstream into the inflamed tissue, for example, the CNS in MS, and the lung airways in asthma. The inhibition of VLA-4 prevents white blood cells from entering sites of inflammation, thereby halting progression of the disease. VLA-4 is a clinically validated target in MS. Antisense inhibition of VLA-4 has demonstrated positive effects in a number of animal models of inflammatory disease including MS.
ATL1102 Phase IIa Study Design Summary
As stated earlier, this study is a multi-centre, randomized, double-blinded, placebo-controlled clinical trial, in approximately 80 patients with relapsing-remitting MS. Patients will receive ATL1102 or placebo over eight weeks. ATL1102 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 Phase IIa trial is to obtain preliminary evidence of the drug’s effectiveness which will be evaluated using MRI (magnetic resonance imaging) indices. MRI’s will be conducted at monthly intervals over the 8 week dosing period and at monthly intervals during the 8 week period following completion of dosing.