ATL1102
Posted: Thu Sep 13, 2007 7:56 am
The ATL1102 trial is progressing, although it's slightly behind schedule.
ATL1102 Phase IIa Multiple Sclerosis Trial Update
Company press release - Antisense Therapeutics is pleased to provide the following update on its ATL1102 Phase IIa Multiple Sclerosis (MS) clinical trial.
The Company is currently conducting this 80 patient trial to assess the safety and efficacy of ATL1102 in relapsing-remitting MS patients in Poland, Czech Republic, Bulgaria, Romania, Slovak Republic and Germany. As previously reported the Company had made an application to conduct the clinical trial in Russia. The Company is pleased to advise that approval for the clinical trial has been granted by the regulatory authorities in Russia. The Company’s ability to receive approval from the regulatory authorities in 7 countries to conduct this study is a reflection of the quality of the ATL1102 clinical trial application.
Screening and enrollment of patients is on-going at all active trial sites. 58 patients have now been enrolled into the study. More than half the enrolled patients have completed the dosing phase of the trial.
The study continues under the supervision of a Data and Safety Monitoring Board - an independent group of neuroscience experts who oversee a strict safety protocol for the conduct of the trial.
While the Company correctly anticipated the timeframe for trial approval in Russia, various administrative processes in Russia have delayed the initiation of the clinical trial at the Russian sites thus impacting on the projected timeline for completion of the trial. The Company now expects that all the remaining patients will be enrolled and the study completed in time for trial results to be reported in 1Q’08, which is slightly later than previous guidance of year end ‘07.
ATL1102 Phase IIa Multiple Sclerosis Trial Update
Company press release - Antisense Therapeutics is pleased to provide the following update on its ATL1102 Phase IIa Multiple Sclerosis (MS) clinical trial.
The Company is currently conducting this 80 patient trial to assess the safety and efficacy of ATL1102 in relapsing-remitting MS patients in Poland, Czech Republic, Bulgaria, Romania, Slovak Republic and Germany. As previously reported the Company had made an application to conduct the clinical trial in Russia. The Company is pleased to advise that approval for the clinical trial has been granted by the regulatory authorities in Russia. The Company’s ability to receive approval from the regulatory authorities in 7 countries to conduct this study is a reflection of the quality of the ATL1102 clinical trial application.
Screening and enrollment of patients is on-going at all active trial sites. 58 patients have now been enrolled into the study. More than half the enrolled patients have completed the dosing phase of the trial.
The study continues under the supervision of a Data and Safety Monitoring Board - an independent group of neuroscience experts who oversee a strict safety protocol for the conduct of the trial.
While the Company correctly anticipated the timeframe for trial approval in Russia, various administrative processes in Russia have delayed the initiation of the clinical trial at the Russian sites thus impacting on the projected timeline for completion of the trial. The Company now expects that all the remaining patients will be enrolled and the study completed in time for trial results to be reported in 1Q’08, which is slightly later than previous guidance of year end ‘07.