ATL1102 Phase IIa Multiple Sclerosis Trial Update - PipelineReview.com | Business Intelligence Center
12 Sep 2007
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.
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 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, the MS animal data having been published in a peer reviewed scientific journal.
ATL1102 Phase IIa Study Design Summary
The study is a multi-centre, randomized, double-blinded, placebo-controlled clinical trial, in approximately 80 patients with relapsing-remitting MS. Patients receive either ATL1102 or placebo over eight weeks. The goal of the Phase IIa trial is to obtain preliminary evidence of the drug’s effectiveness. This is assessed by using MRI (magnetic resonance imaging) indices. MRI’s are conducted at monthly intervals over the 8 week dosing period and at monthly intervals for a further 8 weeks following completion of dosing.
About Antisense Therapeutics Limited
Antisense Therapeutics Limited (ASX: ANP) is an Australian publicly listed biopharmaceutical drug discovery and development company. Its mission is to create, develop and commercialise novel antisense pharmaceuticals for large unmet markets.
SOURCE: Antisense Therapeutics LimitedAntisense Therapeutics Limited is pleased to provide the following update on its ATL1102 Phase IIa Multiple Sclerosis (MS) clinical trial
VICTORIA, Australia | September 12, 2007 | Antisense Therapeutics Limited (ASX:ANP) is pleased to provide the following update on its ATL1102
http://www.pipelinereview.com/joomla/content/view/14464/104/
12 Sep 2007
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.
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 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, the MS animal data having been published in a peer reviewed scientific journal.
ATL1102 Phase IIa Study Design Summary
The study is a multi-centre, randomized, double-blinded, placebo-controlled clinical trial, in approximately 80 patients with relapsing-remitting MS. Patients receive either ATL1102 or placebo over eight weeks. The goal of the Phase IIa trial is to obtain preliminary evidence of the drug’s effectiveness. This is assessed by using MRI (magnetic resonance imaging) indices. MRI’s are conducted at monthly intervals over the 8 week dosing period and at monthly intervals for a further 8 weeks following completion of dosing.
About Antisense Therapeutics Limited
Antisense Therapeutics Limited (ASX: ANP) is an Australian publicly listed biopharmaceutical drug discovery and development company. Its mission is to create, develop and commercialise novel antisense pharmaceuticals for large unmet markets.
SOURCE: Antisense Therapeutics LimitedAntisense Therapeutics Limited is pleased to provide the following update on its ATL1102 Phase IIa Multiple Sclerosis (MS) clinical trial
VICTORIA, Australia | September 12, 2007 | Antisense Therapeutics Limited (ASX:ANP) is pleased to provide the following update on its ATL1102
http://www.pipelinereview.com/joomla/content/view/14464/104/
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