Antisense Therapeutics Provides ATL1102 Phase IIa Multiple Sclerosis Trial Update 01 April 2008
Patient dosing completed
Patient monitoring phase to be completed this month
Results of trial on track to be reported in mid 2008
Antisense Therapeutics Ltd. provided the following update on the Phase IIa clinical trial in patients with relapsing-remitting multiple sclerosis.
The dosing phase of the study has now been completed. All patients enrolled into the study have received either ATL1102 or placebo injections. The next step in the study is the completion of the 8 week monitoring phase of the trial. The last patient is scheduled to complete their final monitoring visit by the middle of this month. This will mark the end of the trial, after which the entry of the clinical trial data into the trial database will be finalised and the database locked for statistical analysis. The results of this analysis will then be reported to the market. The trial remains on track with results to be reported in mid 2008.
As announced last month, ANP has licensed ATL1102 to Teva Pharmaceutical Industries Ltd (Teva). As per the licence agreement, ANP is responsible for the completion of the current Phase IIa trial with Teva to fund and perform all future development of ATL1102 beyond the current trial.
ATL1102 Phase IIa trial is a randomised double-blind, placebo-controlled clinical trial of ATL1102. Patients received either ATL1102 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 The goal of the trial is to obtain preliminary evidence of ATL1102’s effectiveness in reducing the number of MS-related brain lesions as detected by MRI.
ATL1102 is a second generation antisense inhibitor of CD49d, a subunit of VLA-4 (Very Late Antigen-4), and is currently in Phase IIa 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 may prevent white blood cells from entering sites of inflammation, thereby halting progression of the disease. VLA-4 is a clinically validated target in the treatment of MS. Antisense inhibition of VLA-4 has demonstrated positive effects in a number of animal models of inflammatory disease including MS (Myers et al. J Neuroimmunol 160, p12-24, 2005).
Source: Antisense Therapeutics